37

Annual report 2013 pdf

Embed Size (px)

DESCRIPTION

Annual report 2013

Citation preview

Page 1: Annual report 2013 pdf
Page 2: Annual report 2013 pdf
Page 3: Annual report 2013 pdf
Page 4: Annual report 2013 pdf

Letter from the Acting Director General

Annual Report 2013

02

Dear Friends,

I am pleased to present IVI’s 2013 Annual Report. IVI was established in 1997 withthe mandate to develop and introduce vaccines in developing countries against deadlyinfectious diseases that afflict the most vulnerable and poor. Over 16 years of existence,IVI has played a unique and important role - we are the only internationalorganization based in Asia dedicated to vaccines and vaccination for developingcountries, and we are one of the very few nonprofit organizations with a vaccineportfolio that comprises of a vaccine approved by the World Health Organization(WHO).

The year 2013 was one of successes and challenges for IVI. It was a year of financialchallenges but despite the issues, we continued to press on in our vaccine research anddevelopment and in our programs.

We made significant progress in the fight against cholera, building on our pastachievements with the inactivated oral cholera vaccine (OCV) that IVI reformulatedand developed in collaboration with partners from Sweden, Vietnam, and India. TheOCV was tech-transferred to a manufacturer in India, and the vaccine (ShancholTM)was licensed and WHO-prequalified in 2011. In 2013, IVI continued to work onoptimizing the use of the OCV and on facilitating its uptake in settings with endemicand epidemic cholera.

Some of the notable achievements made in these areas include a publication in The Lancet InfectiousDiseases of findings from five years of follow-up of a phase III trial of the OCV, which showed that thevaccine provides sustained protection at about 65 percent for at least five years, a major milestone that noother cholera vaccine has shown so far. A bridging trial with the OCV was completed in Ethiopia - thefirst trial of its kind for the cholera vaccine in Africa - that should pave the way for its widespread use inthis country. We completed a mass vaccination demonstration project with the OCV in Odisha, India,proving that vaccination using the existing public health infrastructure is feasible. Based on this evidence,the Odisha state government is planning to conduct vaccinations for at-risk tribal groups.

Last but not least, we are pleased that the GAVI, the Vaccine Alliance made a commitment in late 2013 tosupport the global stockpile for oral cholera vaccines over the next five years. The stockpile will increaseaccess to the OCV in outbreaks and in endemic settings. To ensure a sufficient supply of the OCV for theglobal market, IVI has been working with a second tech transfer partner, EuBiologics of South Korea onclinical development and manufacturing of the OCV.

We continued to progress on the development of a new vaccine against typhoid. IVI formulated a typhoidconjugate vaccine based on conjugation technology from the U.S. National Institutes of Health, and in2013, transferred the technology to two partners, SK Chemicals of South Korea and PT Biofarma ofIndonesia. Clinical development of the vaccine is ongoing, and we anticipate the vaccine will be WHO-prequalified in the next few years.

Our dengue work also continued through the Dengue Vaccine Initiative (DVI), a consortium led by IVIthat aims to accelerate the development and introduction of dengue vaccines. DVI has been funded by theBill & Melinda Gates Foundation, and in 2013, it was granted new funding from the Foundation tocontinue its work. In addition, the German Federal Ministry of Education and Research (BMBF) becamea donor and is supporting the development of a dengue vaccine candidate in Brazil and Vietnam.

John MorahanActing Director General and Chief Financial Officer (CFO)

Page 5: Annual report 2013 pdf

0033

Our International Advanced Course on Vaccinology in the Asia-Pacific Region marked its thirteenth yearin 2013. The course, which takes place at IVI’s headquarters, aims to provide vaccine professionals fromdeveloping countries a comprehensive overview of vaccinology. Over 60 attendees from 22 countriesincluding Bangladesh, China, India, Nigeria, Thailand, and Vietnam participated in the course.

Our collaborations with various groups in South Korea, IVI’s host country, continued to be strong. Inaddition to SK Chemicals and EuBiologics, some of our partners include the Korea National Institute forHealth for joint research projects, and Seoul National University’s School of Engineering for an innovativeproject that will pilot-test renewable energy sources for vaccine cold chain and delivery in Nepal. LGElectronics and Kia Motors are supporting cholera vaccine introduction projects in Ethiopia and Malawi,respectively.

Equally important, we continued to implement the organizational changes initiated in 2012 in order tostrengthen the Institute’s governance, management and operations. As part of efforts to make sure that wedeliver on our projects, program management was introduced in 2013. New positions were created such asprogram leads for our cholera, enteric fever and dengue franchises, and a grant manager.

Funding was a prominent issue in 2013 but we reduced our deficit by 64 percent compared with 2012(refer to the 2013 Financial Summary for more details). Our major stakeholders also respondedaccordingly. A new agreement was established with the Korean Ministry of Education (the ministry thatoversees IVI within the Korean government) that should help ensure a more stable base for core fundingfrom our host country. The Swedish International Development Cooperation Agency (Sida) provided anadditional contribution. We have also been communicating more with our signatory countries as part ofan effort to engage in a more meaningful dialogue about IVI with our stakeholders. For example, aVaccine Diplomacy Forum was convened by IVI and the Korean Ministry of Foreign Affairs in April 2013that invited diplomatic representatives from IVI’s signatory countries based in Seoul.

I would like to thank the Government of the Republic of Korea, the Bill & Melinda Gates Foundation,and Sida for their continued trust and confidence in IVI. In particular, I would like to thank the KoreanMinistry of Education and the National Assembly for their strong support of IVI in 2013. I also thankBMBF and our Korean partners LG Electronics, Kia Motors, and the Korea Support Committee for IVI(KSC) for their support, in addition to numerous other donors and supporters.

Looking forward, IVI will be continuing efforts to diversify our funding and to increase funding for coreand project support. Despite the financial challenges, IVI remains dedicated to bringing new vaccines topoor populations and to help bridge the gap between vaccines and vaccination. We are committed to ourmission of discovering, developing, and delivering safe, effective and affordable vaccines for developing nations.

Sincerely,

John MorahanActing Director General and Chief Financial Officer (CFO)

Page 6: Annual report 2013 pdf

04

IVI IN BRIEF

In 2011, the World Health Organization (WHO) estimated a totalof 6.9 million children below the age of five died. Among thedeaths, fifty-eight percent were from infectious diseases, and themajority was in Africa and South Asia. Many of these deaths canbe prevented by vaccination. Vaccines are one of the most cost-effective tools in public health and have contributed greatly to theprevention and control of infectious diseases in the 20th century.

Thanks to vaccines, smallpox was eradicated and efforts arecurrently being made to eliminate polio and measles. Whilechildren in developed countries have benefitted from vaccination,many children in developing countries remain unprotected againstpotentially fatal vaccine-preventable diseases.

The International VaccineInstitute (IVI) was founded in1997 as an initiative by theUnited Nations DevelopmentProgramme (UNDP) whorecognized there was a need foran independent internationalorganization with the mandateto improve the health of

children in developing nations through vaccines and vaccination.

IVI’s mission is to discover, develop and deliver safe, effective andaffordable vaccines. Headquartered in Seoul, South Korea, IVI’shost country, IVI has thirty-five signatory countries and WHO toits Establishment Agreement.

“Lab bench to community” approachIVI’s vaccine research spans from “bench to community.” IVI isinvolved in all aspects of bringing a vaccine to reality from:discovering new vaccine technology and developing a new vaccineor improving an existing one; transferring the technology andproviding training and technical support to developing countryvaccine manufacturers; developing assays and conducting clinicaltrials for licensure and WHO prequalification; and generatingscientific evidence for global- and national-level decision makersand donor agencies.

To do all of this, IVI works in collaboration with the internationalscientific community, public health organizations, governments,and industry.

•Number of IVI staff: 138 •Countries represented by IVI staff: 14•Number of countries where IVI works: 27

Bangladesh, Brazil, Burkina Faso, Cambodia, Colombia,North Korea, Ethiopia, Gabon, Ghana, Guinea-Bissau,India, Kazakhstan, Kenya, Kyrgyzstan, Madagascar, Malawi,Mongolia, Nepal, Pakistan, Senegal, South Africa, SouthKorea, Sudan, Tanzania, Thailand, Uganda, Vietnam

Annual Report 2013

Page 7: Annual report 2013 pdf

Geographical Range of IVI’s Work in 2013

Annual Report 2013

05

Page 8: Annual report 2013 pdf

•Publication in The Lancet Infectious Diseases of findings fromfive years of follow-up of a Phase III trial of an oral choleravaccine developed through IVI. This clinical trial, whichassessed vaccine safety and protective efficacy in ~67,000individuals one year and older in Kolkata, India, found thevaccine provided sustained protection at about 65 percent for aleast five years, a major milestone that no other cholera vaccinehas shown thus far.

•Completion of a mass cholera vaccination demonstration projectin a rural endemic community in Odisha, India, which showedthat the oral cholera vaccine can be delivered through the existingpublic health infrastructure. This was the first demonstrationproject of its kind in India with the oral cholera vaccine. Basedon the results, the Odisha state government is planning to conductmore vaccinations in remote areas targeting at-risk tribal groups.

•Establishment of a global cholera vaccine stockpile, using theoral cholera vaccine (ShancholTM) developed through IVI. Inlate 2013, GAVI decided to contribute towards the stockpile toincrease access to oral cholera vaccines in outbreak situations andto further a learning agenda on the use of cholera vaccines inendemic settings. GAVI agreed to support increase of thestockpile capacity from two million doses to 20 million dosesover the next five years. The stockpile, managed by WHO, is anovel mechanism through which the cholera vaccine will bemade available to vulnerable populations to control cholera.

•Technology transfer for a new typhoid conjugate vaccine madeto SK Chemicals of South Korea and PT Biofarma of Indonesia.IVI is working with tech transfer partners, SK Chemicals andBiofarma, on clinical development and manufacturing of a newtyphoid vaccine (Vi-DT conjugate vaccine) with the intent ofgetting the vaccine WHO-prequalified.

•Preliminary analyses of typhoid fever surveillance data fromAfrican field sites indicate considerable typhoid fever burden atsites in Kenya, Burkina Faso, Ghana, Madagascar and Tanzania.A significant proportion of Salmonella Typhi isolates in Ghanaand Kenya were found to be multi-drug resistant. Thesefindings may impact policy decisions on the prevention andcontrol of typhoid. The results are being written up forpublication in 2014.

•Funding granted from the Bill & Melinda Gates Foundationfor two enteric fever projects: 1) late-stage preclinical developmentof a new bivalent conjugate vaccine that protects against typhoidand paratyphoid fever; and 2) continuation of the TyphoidFever Surveillance in Africa Program (TSAP), which aims togenerate scientific evidence on the burden of typhoid and otherinvasive Salmonella infections in Africa.

•Funding granted from the Bill & Melinda Gates Foundationand the German Federal Ministry of Education and Research(BMBF) for work in dengue. The Gates Foundation has beensupporting the Dengue Vaccine Initiative (DVI), an initiativeled by IVI, and has granted new funding to DVI to continue itswork in paving the way for dengue vaccine introduction. TheGerman grant, a first for IVI and DVI, will cover provision oftechnical assistance and support to Vabiotech (Vietnam) andInstituto Butantan (Brazil) for the development of their denguevaccine candidates.

•A total of 66 publications in peer-reviewed scientific journalsby IVI scientists. Some highlights include the five-year efficacyresults of the IVI-developed oral cholera vaccine (OCV) in TheLancet Infectious Diseases,1 demonstration of herd protection bythe OCV in Clinical Infectious Diseases,2 and description of anenzyme-linked immunospot assay to measure vaccine-inducedimmune responses in human blood in Nature Protocols.3 For thecomplete list of publications, please see the Appendices.

2013 MILESTONES

Annual Report 2013

1Bhattacharya SK, Sur D, Ali M, Kanungo S, You YA, Manna B, Sah B, Niyogi SK, Park JK, Sarkar B, Puri MK, Kim DR, Deen JL, Holmgren J, CarbisR, Dhingra MS, Donner A, Nair GB, Lopez AL, Wierzba TF, Clemens JD. 5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata,India: a cluster-randomised, double-blind, placebo-controlled trial. Lancet Infect Dis 2013/Dec; 13(12): 1050-6.

2Ali M, Sur D, You YA, Kanungo S, Sah B, Manna B, Puri M, Wierzba TF, Donner A, Nair GB, Bhattacharya SK, Dhingra MS, Deen JL, Lopez AL,Clemens J. Herd protection by a bivalent killed whole-cell oral cholera vaccine in the slums of Kolkata, India. Clin Infect Dis 2013/Apr; 56(8): 1123-31.

3Saletti G, Cuburu N, Yang JS, Dey A, Czerkinsky C. Enzyme-linked immunospot assays for direct ex vivo measurement of vaccine-induced humanhumoral immune responses in blood. Nat Protoc 2013/Jun; 8(6): 1073-87.

06

Page 9: Annual report 2013 pdf
Page 10: Annual report 2013 pdf

IVI conducts basic research to discover and design new vaccines foruse in developing countries. Namely, vaccines that are low-cost,easy to administer in resource-poor settings, can be produced byqualified manufacturers in these countries, and protect againstdiseases of public health importance in these countries. Whenproof of concept is established for a promising vaccine candidate inthe IVI labs, IVI works with a variety of partners to bring thevaccine to market, which includes technology transfer, clinicaldevelopment, and manufacturing - with the end goal of obtainingWHO prequalification for the vaccine.

In 2013, IVI clarified the participation of mucosal dendritic cellsin the induction of protective immunity by vaccines deliveredthrough the sublingual or trans-cutaneous route, and madeprogress in the development of a novel strategy for vaccineadministration that involves sublingual vaccination (absorption ofthe vaccine under the tongue). The following provide in furtherdetail some major highlights from IVI’s basic research programs in2013. IVI’s basic research has been supported by the NationalResearch Foundation of Korea and the Swedish InternationalDevelopment Cooperation Agency (Sida).

Discovery of a new vaccine against dysenteryIn 2013, IVI yielded promising data from its preclinicaldevelopment of a vaccine against bacillary dysentery (shigellosis).Dysentery is caused by the bacterial agent, Shigella, which has fourspecies and 50 serotypes that cause disease. IVI has been workingon the development of the first universal Shigella vaccine thatprotects across all species and serotypes. IVI genetically modifiedthe Shigella bacterium, creating a mutant bacterium that expressesa shorter lipopolysaccharide on the cell wall, which, in turn,increases the surface exposure of membrane antigens, including

protein antigens that are conserved across different species andserotypes of Shigella. IVI demonstrated that intranasal immunizationwith three doses of mutant bacteria (live or formalin-inactivated)induced cross-protection against Shigella flexneri 2a and Shigelladysenteriae 1 in mice. The findings show that a vaccine usinggenetically modified bacteria with enhanced exposure of commonouter membrane proteins could be an efficacious approach todevelop a universal Shigella vaccine.

PROVIDE StudyIVI continued to work on PROVIDE, a study supported by theBill & Melinda Gates Foundation, that assesses the effect ofmalnutrition on the immune response since it has been commonlyobserved that children from developing countries have a decreasedresponse to live oral vaccines compared with that of children fromdeveloped countries. IVI is part of an international consortiumthat includes the University of Virginia, India’s National Instituteof Cholera and Enteric Diseases (NICED), the University ofVermont, Stanford University, Washington University in St.Louis, and Bangladesh’s icddr,b.

IVI, with NICED, is conducting research in Kolkata, India thatmeasures immunogenicity against live oral polio virus (OPV) androtavirus vaccines in young children. Enrollment has beencompleted and laboratory testing of samples is ongoing.Preliminary data analysis suggests there is a poor immune responseoverall to both vaccines with immunogenicity less than 40 percent.Furthermore, there appears to be a negative correlation betweenmaternal breast milk antibody titers and the infant’s immuneresponse to vaccination, suggesting that breast milk antibodies mayinterfere with the infant’s gut immune response.

Discovery and Pre-clinical Studies

Annual Report 2013

09

IVI scientists Deok Ryun Kim (thirdfrom right) and Ayan Dey (seventhfrom right) at the enrollment of thefirst child in the PROVIDE study atthe field site in Kolkata, India.

Page 11: Annual report 2013 pdf
Page 12: Annual report 2013 pdf

Critical to IVI’s work is vaccine development. When a promisingvaccine candidate is discovered and proof of concept is establishedin IVI’s labs, IVI takes it to later stages of product developmentthat include: process and formulation development; technologytransfer to manufacturing partners; manufacturing, and qualitycontrol; clinical development; and regulatory review and approval,including WHO prequalification. The ultimate aim is to makesafe, effective and affordable vaccines available for the world’s mostimpoverished people.

In 2013, IVI’s Process Development and Technology Transferteam made progress in the development of new production methodsto reduce the cost of manufacturing typhoid and paratyphoid

vaccines, which can help lower the vaccine cost and make it moreaffordable. Additionally, they came one step closer to realizing anew typhoid vaccine for the poor by conducting technologytransfer to two partners, SK Chemicals in South Korea and PTBiofarma in Indonesia. Having two suppliers of the new typhoidvaccine will help ensure a cost-competitive and adequate globalsupply for those who need the vaccines the most. More detailsprovided in IVI’s Vaccine Portfolio below.

This work has been made possible with support from the Bill &Melinda Gates Foundation, the National Research Foundation ofKorea, and the Swedish International Development CooperationAgency (Sida).

Process Development and Technology Transfer

Annual Report 2013

Vaccine IVI’s Role Status

Two-dose killed whole-cell oral cholera vaccine

IVI, in collaboration with partners in Sweden,Vietnam and India, reformulated anddeveloped an existing oral cholera vaccineto meet WHO standards, thereby allowingglobal access of the vaccine.

IVI’s first product to be licensed and WHO-prequalified (licensed in India as ShancholTM

in 2009 and WHO-prequalified in 2011). AWHO global cholera vaccine stockpile wasestablished in late 2013, and the vaccine hasbeen deployed in endemic and epidemicareas in countries such as Haiti, Guinea,South Sudan, Bangladesh, and India.

IVI continued to optimize the use of thevaccine through several clinical studies (e.g.,single-dose study and dose-interval study)and to increase the global supply of thevaccine by working with an additional techtransfer partner, EuBiologics, in South Korea.

Vi polysaccharide-diphtheria toxoid (Vi-DT) conjugate typhoid vaccine

IVI developed this new typhoid vaccinebased on conjugation technology from theU.S. National Institutes of Health. The Vipolysaccharide of Salmonella Typhi isconjugated to diphtheria toxoid.

Unlike existing typhoid vaccines, this vaccineis anticipated to confer protection in infants,as well as a longer duration of protection.

Technology transferred to two partners, SKChemicals of South Korea and PT Biofarmaof Indonesia, in 2013. Clinical developmentto follow.

Bivalent enteric fever conjugate vaccine (protects against both typhoid and paratyphoid fever)

Based on similar conjugation technology forthe Vi-DT typhoid vaccine, IVI developedtyphoid and paratyphoid conjugates for thevaccine; formulation work is ongoing.

Under preclinical development. Developednew methods of production to reduce themanufacturing cost, which can lower the costof the vaccine and make it more affordable.

Vi-PspA conjugate vaccine (Viconjugated to PspA, a commonprotein antigen of Streptococcuspneumoniae); has potential toprotect against typhoid andpneumonia.

IVI developed the Vi-PspA conjugates and isassessing the use of PspA in Vi conjugate vaccines.

Under preclinical development.

IVI’s Vaccine Portfolio

13

Page 13: Annual report 2013 pdf

IVI staff Jayoung Kim with children at the field site in Odisha, India.

IVI’s Cholera Vaccine Program aims to reduce the burden ofcholera through the development and deployment of safe, effective,and affordable oral cholera vaccines in populations at risk forendemic or epidemic cholera. IVI has made significant stridestowards this goal. With partners in Vietnam, India, and Sweden,IVI reformulated and developed a two-dose, killed, whole-cell, oralcholera vaccine that was licensed in India (ShancholTM) in 2009and WHO-prequalified in 2011.

In 2013, IVI continued to work on optimizing the use of the oralcholera vaccine and on promoting its uptake in developingcountries. IVI concluded five years’ follow-up of a phase 3 clinicaltrial in Kolkata, India, demonstrating that the vaccine providessustained protection at an efficacy of 65 percent for at least fiveyears - a milestone that no other cholera vaccine has been shown toachieve thus far.1

IVI completed a study in Kolkata that evaluated a boostingregimen of ShancholTM. Interestingly, a one-dose boosting regimenof the vaccine was found to be comparable with that of a two-dose.This has significant public health implications since administeringa single dose of the vaccine could reduce the logistical challengesand costs of vaccination campaigns that are conducted in resource-limited settings. IVI, in collaboration with icddr,b, finalizedpreparations to conduct a large trial that will evaluate the efficacyof a single dose of ShancholTM in Dhaka, Bangladesh. Positivefindings from this study could greatly influence strategies fordelivery of this vaccine, particularly in cholera outbreaks andhumanitarian crises.

In addition, IVI completed a mass vaccination demonstrationproject in a rural, cholera-endemic community in Odisha, India,which showed that the oral cholera vaccine can be deliveredthrough a program that effectively engages the community anduses Odisha’s existing public health resources - the first project ofits kind. Based on the study’s success, the state government ofOdisha is planning to conduct cholera vaccinations in more remoteareas targeting vulnerable tribal groups.

Similarly, IVI worked with the governments of Ethiopia andMalawi to conduct mass vaccination demonstration projects incholera-affected areas in those countries. A bridging trial with theoral cholera vaccine was completed in Ethiopia, the first trial of itskind for the cholera vaccine in Africa. The mass vaccinations areslated for 2014. At a broader level, IVI collaborated with JohnsHopkins University to document and synthesize lessons learnedfrom past cholera vaccination campaigns and to develop a practicalmanual for planning and implementing cholera vaccination

campaigns in developing countries; such information will includehow to implement and evaluate communications and estimationsof vaccination campaign costs, health impact, and cost effectiveness.

IVI continued to work with GAVI by providing them technicalsupport and data regarding the oral cholera vaccine and on theburden of cholera. This contributed to their decision at the end of2013 to invest in a global cholera vaccine stockpile that wasestablished by WHO. The stockpile, initially consisting of twomillion doses of the oral cholera vaccine, is a novel mechanismthrough which the cholera vaccine could be made available tovulnerable populations to control cholera.

While the stockpile should help increase access of the vaccine forimpoverished and at-risk groups, there is currently only onesupplier of the oral cholera vaccine. Given that the global demandmay outstrip supply, IVI has been collaborating with additionalmanufacturers to help ensure a sufficient global supply of the oralcholera vaccine. IVI transferred the production technology for theoral cholera vaccine to a manufacturer in South Korea (EuBiologics)and has been working with this group to develop the vaccine andbring it to licensure and WHO prequalification. IVI has beenworking closely with other manufacturers in Vietnam andBangladesh to support the development of the oral cholera vaccine.

IVI gratefully acknowledges the government of Korea, the SwedishInternational Development Cooperation Agency (Sida), Bill &Melinda Gates Foundations, LG Electronics, and Kia Motors fortheir generous support of the Cholera Program.

Cholera Program

Annual Report 2013

1Bhattacharya SK, Sur D, Ali M, Kanungo S, You YA, Manna B, Sah B, Niyogi SK, Park JK, Sarkar B, Puri MK, Kim DR, Deen JL, Holmgren J, CarbisR, Dhingra MS, Donner A, Nair GB, Lopez AL, Wierzba TF, Clemens JD. 5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata,India: a cluster-randomised, double-blind, placebo-controlled trial. Lancet Infect Dis 2013/Dec; 13(12): 1050-6.

14

Page 14: Annual report 2013 pdf

IVI’s Enteric Fever Program was established with the goal ofreducing the burden of enteric fever in developing countries through:1) generating evidence on the disease burden; 2) deployingcurrently available vaccines; 3) developing new vaccines; and 4)advocating for the control of enteric fever by vaccination.

Many people associate enteric fever with typhoid fever, a potentiallyfatal illness caused by Salmonella enterica, subspecies entericaserovar Typhi. But enteric fever also includes paratyphoid fever,which is caused by related serovars Paratyphi A, B, and C, and ismainly a public health problem in South Asia; and non-typhoidalSalmonella infections, which tend to be common in sub-SaharanAfrica.

IVI’s Vi-based Vaccines for Asia (VIVA) Initiative has a two-foldapproach: 1) to develop a new Vi-based typhoid conjugate vaccine;and 2) to pave the way for vaccine introduction in endemic Asiancountries through policy and advocacy activities and provision ofevidence that the vaccination is effective and programmaticallyfeasible. VIVA is supported by the Bill & Melinda Gates Foundation.

A new typhoid conjugate vaccineIVI has been developing a new typhoid conjugate vaccine thatconsists of Vi-polysaccharide conjugated to diphtheria toxoid (Vi-DT). Unlike existing Vi-polysaccharide vaccines, the new vaccineis anticipated to confer protection in infants and provide a longerduration of protection. In 2013, IVI transferred the vaccineproduction technology to SK Chemicals of South Korea and PTBiofarma of Indonesia. IVI is working with these partners ondevelopment of the vaccine and obtaining WHO prequalification.

To support clinical development of the typhoid conjugate vaccine,IVI has been developing a functional serum bactericidal assay(SBA) for Salmonella Typhi. The assay is currently being validatedand will be available for transfer to interested partners in 2014.

Paving the way for vaccine introductionIVI and local partners coordinated school-based vaccinationcampaigns in Nepal and Pakistan using the Vi-polysaccharidetyphoid vaccine in 2012. Case-control studies to assess the impactof the Vi-polysaccharide vaccine were completed in Nepal andPakistan in 2013. As a follow-up, IVI was invited by Nepal’sNational Committee on Immunization Practices (NCIP), animmunization technical advisory group that providesrecommendations to the Nepal government, to discuss the studyresults and the status of typhoid vaccination in Nepal, focusing onthe new typhoid conjugate vaccine. Meanwhile, in Pakistan, aworkshop is being planned in order to share and discuss the studyresults with key stakeholders.

IVI continued to work on developing a global investment case fortyphoid vaccines, which will serve as a decision-making tool for

policy makers, vaccine manufacturers, and donors at global,regional, and national levels, particularly the WHO and the GAVIAlliance. To assist in the development of the investment case, IVIformed an internal advisory committee and an external technicalreview committee in coordination with the Coalition againstTyphoid (CaT). The committees will review and advise on thetechnical aspects of the investment case. In 2013, a dynamicdisease transmission model to predict the transmission of typhoidthat was developed by IVI was refined and finalized. Publicationsregarding this model are being prepared.

Future steps - a new bivalent enteric fever vaccineIn 2013, IVI made progress in its efforts to develop a new bivalentvaccine against both typhoid and paratyphoid fever based onsimilar conjugation platform technology used for the Vi-DTconjugate vaccine. Preclinical work of the vaccine continued inIVI process development laboratory. In addition, IVI isdeveloping a functional assay for Salmonella Paratyphi A (thebacterial agent of paratyphoid fever), which will be used tomeasure immunogenicity of the bivalent vaccine in clinical trials.

A flyer about typhoid and vaccination was distributed to the communityas part of social mobilization efforts for the typhoid vaccination campaignin Nepal.

Enteric Fever Program

Annual Report 2013

15

Page 15: Annual report 2013 pdf

IVI scientist Dr. Florian Marks conducting training with local collaboratorsat a TSAP field site in Senegal.

Finally, IVI conducted a landscape analysis to assess the globalstatus of the development of typhoid and paratyphoid conjugatevaccines, looking at target product profile among other criteria. Inaddition, IVI was granted funding from the Bill & Melinda GatesFoundation to support late-stage preclinical development of thebivalent vaccine.

IVI’s Typhoid Fever Surveillance in Africa Program (TSAP), amulti-year program supported by the Bill & Melinda GatesFoundation aims to generate scientific evidence on the burden oftyphoid fever in Africa through conducting standardizedsurveillance among a network of field sites in ten African countries(Ghana, Kenya, South Sudan, Madagascar, Guinea-Bissau,Senegal, South Africa, Tanzania, Ethiopia, and Burkina Faso). IVIcoordinates the network and provides training and technicalsupport to each of the sites. The surveillance process involvedenrollment of patients with fever at the field site hospitals anddiagnostics of the patients’ blood cultures at TSAP-monitoredlaboratories.

In 2013, surveillance was completed at most of the sites, and dataanalyses started. The incidence of typhoid fever was high at sites inKenya, Burkina Faso and Ghana, as well as at sites in Madagascarand Tanzania. Risk factors that may be associated with the disease(e.g., age, residence, clinical parameters) will be evaluated furtherand may impact policy decisions on prevention and treatmentefforts by national stakeholders.

TSAP provides insight into the burden of other diseases causingfebrile illness, and as such has yielded data on other vaccine-preventable illnesses such as infections caused by Streptococcuspneumoniae. In addition, it was found that a significant proportionof Salmonella Typhi isolates in Ghana and Kenya were found to bemulti-drug resistant, which has raised considerable attention.These results are being summarized for publication in 2014.

IVI was granted follow-on funding from the Bill & Melinda GatesFoundation to continue the program. IVI also received fundingfrom the Else Kroner-Fresenius-Stiftung of Germany to conductcapacity-building activities at two of the TSAP study sites: BurkinaFaso and Madagascar.

16

Page 16: Annual report 2013 pdf

IVI is the lead coordinating agency of the Dengue VaccineInitiative (DVI), an integral part of IVI’s efforts to accelerate thedevelopment and delivery of new dengue vaccines. DVI is aconsortium consisting of IVI, the International Vaccine AccessCenter (IVAC) of Johns Hopkins University, the Initiative forVaccine Research (IVR) of the World Health Organization(WHO), and Sabin Vaccine Institute. Supported by the Bill &Melinda Gates Foundation, DVI’s mission is to encourage thedevelopment and consideration of new vaccines to prevent dengue,and as such, lays the groundwork for dengue vaccine decision-making and introduction in endemic areas. Currently thegeographic scope of DVI’s work is Brazil, Colombia, Thailand,and Vietnam - the potential ‘early adopter’ countries or countriesthat have expressed interest in dengue vaccine introduction as soonas one becomes available.

As a DVI member, IVI is responsible for developing scientificevidence for decision-making regarding dengue vaccineintroduction, which includes disease burden and economic burdenestimates, serological studies, vaccine demand estimates, andvaccine impact projections. WHO IVR is responsible forregulatory issues while IVAC oversees financing and demandforecasting and Sabin is responsible for advocacy andcommunications.

In 2013, IVI made significant progress with the development of amathematical model to project vaccine impact in Thailand, theresults of which were published in the open access journal PLOS

Neglected Tropical Diseases.1 A similar model for Latin America isunder development. IVI and local research partners in Thailand,Columbia, and Vietnam continued field work on surveillance,sero-prevalence studies, cost-of-illness surveys, and healthcareutilization surveys. Additionally, IVI prepared for the launch ofdengue surveillance and sero-prevalence studies at selected fieldsites in Africa - a first for DVI - to assess the public healthmagnitude of dengue in Africa.

In order to create an enabling environment at the national,regional, and global levels for the introduction of dengue vaccines,DVI has continued to maintain the Dengue Prevention Board(DPB), one for the Asia-Pacific region and one for the Americasregion, since its establishment in 2007. The two boards, which arecomprised of dengue experts, policy makers, and other keystakeholders, usually meet annually, and in 2013, the Asia-PacificDPB convened in Bangkok, Thailand. DVI also convenedmeetings in Brazil and Thailand with the National RegulatoryAuthorities of countries that have expressed interest in the earlyadoption of dengue vaccines. Finally, in 2013, DVI receivedfunding from the Bill & Melinda Gates Foundation and theGerman Federal Ministry of Education and Research (BMBF). Forthe German grant, DVI will provide technical assistance andsupport to Vabiotech (Vietnam) and Instituto Butantan (Brazil) onthe development of their dengue vaccine candidates.

For more information about DVI and the work of DVI partners,visit: http://www.denguevaccines.org/

Dengue Program

Annual Report 2013

1Chao DL, Longini IM Jr, Halloran ME. The effects of vector movement and distribution in a mathematical model of dengue transmission. PLoS One2013/Oct/21; 8(10): e76044.

17

Dengue disease outcome studies are conductedby IVI and local partners at the field site inBang Phae district of Ratchaburi, Thailand.

Page 17: Annual report 2013 pdf

IVI has been working in the Democratic People’s Republic ofKorea (DPRK; North Korea) since 2006 in collaboration with theAcademy of Medical Science (AMS), North Korea’s main center ofmedical research, to improve the health of children in the country.The North Korea Program was launched in 2007 with supportfrom the South Korean Ministry of Unification (MOU) to preventand control Japanese encephalitis (JE) and Haemophilus influenzaetype b (Hib), two deadly infectious diseases affecting the centralnervous system. North Korean scientists were introduced to modernapproaches in vaccine development and regulation, and laboratorydiagnostic methods for JE and Hib through study visits andworkshops in China and Vietnam. IVI also provided technicalsupport in the implementation of pilot JE and Hib vaccinationcampaigns that targeted a total of 6,000 children in Nampo, SouthPyongan Province (Hib) and Sariwon, North Hwanghae Province(JE).

IVI, in collaboration with AMS, initiated a new project in 2012 toreduce the burden of diarrheal disease and acute encephalitissyndrome (AES) among children in North Korea, with supportfrom MOU. In 2013, IVI supported a JE vaccination campaigncoordinated by Caritas Germany and the North Korean Ministryof Public Health (MOPH) in which over 3 million children wereimmunized. IVI also conducted training of AMS scientists for thesurveillance of AES and diarrheal diseases, and several workshopson the clinical and laboratory diagnosis of AES and diarrhealdiseases were organized by IVI. By the end of 2013, five hospitalsin two provinces were selected to start systematic diarrheal andmeningeal disease surveillance with the possibility of extending toinclude diagnoses of invasive bloodstream infections and otherdiseases. Surveillance will be launched in 2014 contingent uponfunding.

North Korea Program

Annual Report 2013

18

IVI provided technical support to North Korea’sAcademy of Medical Sciences and Ministry of PublicHealth in the implementation of a Hib vaccinationcampaign in Nampo, South Pyongan Province.

Page 18: Annual report 2013 pdf

IVI’s Policy and Economic Research (PER) Center focuses onincreasing the use of evidence-based analyses by global-andnational-level policymakers in vaccine introduction decision-making. The PER Center works closely with major players in theglobal health community (e.g., GAVI Alliance and WHO) toensure that the evidence generated by IVI’s research is incorporatedin major vaccine introduction deliberations. The PER Centerdisseminated research findings through 14 presentations at various meetings and conferences worldwide in 2013.

In 2013, the PER Center conducted several cholera analyses basedon IVI data that was used by GAVI in their Cholera VaccineInvestment Strategy, resulting in the decision by GAVI to financethe global cholera vaccine stockpile. The stockpile, managed byWHO, will deploy the oral cholera vaccine (ShancholTM) that wasdeveloped by IVI mainly in emergency situations to combatepidemic cholera. The establishment of the stockpile has created anew framework for the supply and financing of the cholera vaccinein several developing countries where cholera outbreaks arecommon.

As part of the PER Center’s work on making the case for aninvestment in oral cholera vaccines, a report detailing the scientificevidence for the introduction of the oral cholera vaccine inBangladesh1 was published in March 2013. The PER Center alsopublished several other abstracts and papers regarding the choleraburden in Uganda,2 the cholera vaccine stockpile,3 and the cost-effectiveness of vaccination at the global level.4

The PER Center also conducts studies and analyses for typhoidand dengue vaccines. In 2013, the Center completed severalanalyses for an investment case in typhoid vaccines and disseminatedthe findings to key stakeholders such as GAVI and WHO. Theresults were used by GAVI as evidence to support their decision toinvest in the new typhoid conjugate vaccine. The WHO will alsoconsider the findings generated by the PER Center for policyrecommendations on typhoid vaccines. The PER Center conducteddengue studies (cost-of-illness study and willingness-to-pay-for-vaccine study) in Thailand, Vietnam, and Colombia in collaborationwith the Dengue Vaccine Initiative (DVI). The findings fromthese studies will help make the case for dengue vaccine use.

Policy && Economic Research CenterEnsure that the vaccines developed by IVI will actually be used in places that need them the most

Annual Report 2013

1Country investment case study of cholera vaccination: Bangladesh. International Vaccine Institute. Seoul, South Korea, 2013.

2Bwire G, Malimbo M, Maskery B, Kim YE, Mogasale V, Levin A. The burden of cholera in Uganda. PLoS Negl Trop Dis. 2013 Dec;7(12):e2545.

3Maskery B, DeRoeck D, Levin A, Kim YE, Wierzba TF, Clemens JD. Strategy, demand, management, and costs of an international cholera vaccinestockpile. J. Infect. Dis 2013; 208 Suppl 1: S15-22.

4Mogasale V, Levin A. Maskery B, DeRoeck D, Kim YE, Clemens J, Lopez AL, Burgess C, Wierzba T. Oral cholera vaccines to control endemic disease:an economic and epidemiological modelling analysis. Lancet. 2013 Oct; 382:6 (abstract).

19

IVI has developed analyses such as investment cases for oral cholera vaccines,which have been referenced by decision makers and donors.

Page 19: Annual report 2013 pdf

Biostatistics && Data Management

Annual Report 2013

20

Biostatistics & Data Management supports IVI’s field research,which includes clinical trials, vaccination campaigns, and diseasesurveillance studies. The Biostatistics & Data Management teamconducts data management, statistical analyses, mathematicalmodeling of infectious diseases, and medical geographic research(i.e., population-based studies in which study participants can beidentified by their geographic location such as the evaluation ofherd protection conferred by vaccines). Besides providing supportto IVI’s field research, the team also conducts their own research.

In 2013, there were three major scientific publications forBiostatistics & Data Management. The five-year efficacy results ofthe inactivated oral cholera vaccine (OCV) developed by IVI werepublished in The Lancet Infectious Diseases.1 Data analysis by theBiostatistics & Data Management team found that the OCVprovides sustained protection at a field site in Kolkata, India forfive years at 65 percent. This level of protective efficacy has notbeen demonstrated with other oral cholera vaccines. The team alsodemonstrated evidence of herd protection by the OCV in Kolkata,India, which was published in Clinical Infectious Diseases.2 Herdprotection occurs when the vaccination of a significant portion of apopulation prevents the spread of infectious disease to unvaccinatedindividuals. The team conducted an analysis and found that non-vaccinees were protected against cholera. The findings havepractical implications since this additional and indirect benefit ofthe OCV can help further develop the case for vaccine use. Lastly,high-risk areas for cholera were identified and analyzed using ageneralized additive model (GAM) to detect risk areas, and toevaluate the importance of socio-environmental characteristics, whichwas published in PLoS One.3 The GAM-based risk map is usefulfor policymakers, especially those from countries where choleraremains to be endemic with periodic outbreaks.

1Bhattacharya SK, Sur D, Ali M, Kanungo S, You YA, Manna B, Sah B, Niyogi SK, Park JK, Sarkar B, Puri MK, Kim DR, Deen JL, Holmgren J, CarbisR, Dhingra MS, Donner A, Nair GB, Lopez AL, Wierzba TF, Clemens J. 5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata, India:a cluster-randomised, double-blind, placebo-controlled trial. Lancet Infectious Disease 2013 Dec; 13(12):1050-6.

2Ali M, Sur D, You YA, Kanungo S, Sah B, Manna B, Puri M, Wierzba TF, Donner A, Nair GB, Bhattacharya SK, Dhingra MS, Deen JL, Lopez AL,Clemens J. Herd protection by a bivalent killed whole-cell oral cholera vaccine in the slums of Kolkata, India. Clin Infect Dis 2013/Apr; 56(8): 1123-31.

3You YA, Ali M, Kanungo S, Sah B, Manna B, Puri M, Nair GB, Bhattacharya SK, Convertino M, Deen JL, Lopez AL, Wierzba TF, Clemens J, Sur D.Risk Map of Cholera Infection for Vaccine Deployment: The Eastern Kolkata Case. PLoS One 2013 Oct 11;8(10).

Page 20: Annual report 2013 pdf

IVI scientist Dr. Batmunkh Nyambat (first row, far left) at the consultativeworkshop on strengthening of NCIP of the Republic of Maldives co-organized by the WHO South-East Regional Office and in collaborationwith SIVAC Initiative in Male, Maldives, July 15-17, 2013.

The SIVAC (Supporting Independent Immunization and VaccineAdvisory Committees) Initiative was established in 2008, with theaim to support low- and middle-income countries in Asia andAfrica in establishing or strengthening National ImmunizationTechnical Advisory Groups (NITAGs). NITAGs issuerecommendations to governments based on scientific evidence, andthus, are a key means through which countries can make informeddecisions with regards to vaccine introduction and immunizationprograms. SIVAC is implemented jointly by IVI and the France-based Agence de Medecine Preventive (AMP), and is supported bythe Bill & Melinda Gates Foundation.

As a result of SIVAC, NITAGs were established for the first timein Mongolia, Kyrgyzstan, and Kazakhstan. Following their launch,IVI has continued to work with these NITAGs to ensuresustainability and smooth operations. In 2013, IVI provided avariety of technical support to the NITAGs and their scientificsecretariats in Mongolia, Kyrgyzstan, and Kazakhstan.

SIVAC builds capacity in existing NITAGs by providing training,technical assistance, and an information resource center forNITAGs that can be accessed on the SIVAC website. In particular,IVI has been working with Nepal’s National Committee onImmunization Practices (NCIP), and in 2013, provided technicalsupport to the NCIP regarding cholera and typhoid vaccinationprogram. SIVAC also organizes training workshops for NITAGs inthe Asia-Pacific Region. In 2013, SIVAC, in collaboration withthe WHO Regional Office for Europe and the US Centers forDisease Control and Prevention (CDC), organized a trainingworkshop for NITAG members from Central Asia and EasternEurope in Antalya, Turkey. In addition, SIVAC and the WHORegional Office for South-East Asia co-organized an orientationworkshop on strengthening of the National Committee ofImmunization Practices (NCIP) of the Republic of Maldives.Finally, SIVAC co-organized a study tour in Canberra, Australiafor a delegation from Nepal to observe the Australian TechnicalAdvisory Group on Immunization in June.

For more about SIVAC: http://www.sivacinitiative.org/

SIVAC Initiative

Annual Report 2013

21

Page 21: Annual report 2013 pdf
Page 22: Annual report 2013 pdf

Participants of the 2013 Advanced Vaccinology Course.

IVI’s International Advanced Course on Vaccinology in the Asia-Pacific Region marked its thirteenth year in 2013. The annualcourse, which runs for about a week in May at IVI’s headquartersin Seoul, aims to provide vaccine professionals from developingcountries a comprehensive overview of vaccinology. During thecourse, AVC faculty, which consisted of more than 30 internationalexperts, lectured on topics that span from basic epidemiology tovaccine development to vaccine introduction.

Over 60 attendees from 22 countries including Bangladesh, China,India, Nigeria, Sudan, Thailand and Vietnam participated in thecourse. The participants were a diverse mix of scientists, publichealth officials, and policymakers from private and public sectors,including 14 fellows - IVI annually awards competitive fellowshipsto individuals with demonstrated financial need.

This year’s course focused on vaccine development and evaluation,as well as on hepatitis E, human papilloma virus, tuberculosis,HIV, influenza, and malaria. The course was supported byGlaxoSmithKline, Pfizer, Korea Exchange Bank (KEB) Foundation,and the Export-Import Bank of Korea.

Advanced Vaccinology Course(AVC)

Annual Report 2013

25

Page 23: Annual report 2013 pdf

IVI’s Scholar in Residence (SIR) is a program supported by Merck& Co. that invites leading scientists and scholars from around theworld to the IVI headquarters in Seoul, Korea where they caninteract with IVI scientists and scientists from Korea. Theprogram, which was initiated in 2006, aims to expose the latest

developments in vaccinology to IVI scientists and the Koreanscientific community; provide mentoring opportunities for youngresearchers; and provide opportunities for research collaborations.In 2013, IVI welcomed six scholars, the details of which are below.

Scholars in Residence Program

Annual Report 2013

Scholar Affiliation Research Interests Dates at IVI Lecture Topic

Dr. Marcel TannerSwiss Tropical & Public Health Institute, Switzerland

Research on communicable diseases control (malaria and schistosomiasis), on health planning/priority setting, health systems, and on environmentand health/ecosystem health

Aug. 23, 2013

From efficacy to effectiveness - communicable diseases control and its integration into health systems

Prof. Robert Black

Johns Hopkins University Bloomberg School of Hygiene & Public Health, USA

Field trials of vaccines, micronutrients and other nutritional interventions, effectiveness studies of health programs

Oct. 21-23, 2013

Trends in major causes of child mortality and estimates for 2012

Dr. Claudio LanataInstituto de Investigacion Nutricional, Peru

Clinical trials and vaccine development

Oct. 21-23, 2013

Causes of death due to diarrheal diseases in children <5 years old in the world: The CHERG estimates

Dr. Peter SmithLondon School of Hygiene & Tropical Medicine, UK

Epidemiological and statistical research, large-scale intervention studies against tropical diseases, including vaccine trials

Oct. 21-23, 2013

Progress in the evaluation of the RTS,S malaria vaccine for deployment in Africa

Dr. Pearay OgraState University of New York at Buffalo, USA

Mucosal immunity, childhood vaccines and, definition of biologic markers of immunity against human infections acquired via mucosal routes

Oct. 21-23, 2013

Development of immune system in early childhood: Implications in effective vaccination approaches

Dr. David Sack

Johns Hopkins University Bloomberg School of Public Health, USA

Diarrheal diseases, especially cholera and enterotoxigenic E. coli

Oct. 21-23, 2013

Cholera vaccine: The role of operations research during the transition from effectiveness to implementation

26

Page 24: Annual report 2013 pdf
Page 25: Annual report 2013 pdf

Members-at-large

Prof. Adel A.F. Mahmoud (Chair)Department of Molecular Biology and the WoodrowWilson School of Public and International Affairs,Princeton UniversityU.S.A.

Mr. George Bickerstaff (Treasurer / Chair of FinanceCommittee)Partner and Managing Director, M.M. Dillon & Co.U.S.A

Prof. Juhani EskolaDirector GeneralNational Institute for Health and Welfare (THL)Finland

Representatives of WHO, UNDP, and the HostCountry (Republic of Korea)

Dr. Shin Young Soo Regional Director WHO Western Pacific Regional Office (WPRO)Philippines

Mr. Romulo GarciaSenior AdviserRegional Bureau for Asia and the Pacific, UNDP New York

Mr. Moon-hwan Kim Director General International Organizations BureauMinistry of Foreign Affairs Republic of Korea

Dr. Young-Soon Kang Director General International Cooperation BureauMinistry of EducationRepublic of Korea

Representatives of State Parties to Establishment Agreement

Prof. Dr. Claire J.P. Boog Scientific Director Institute for Translational Vaccinology (Intravacc)The Netherlands

Dr. Viveka Persson - Vice Chair / Chair of Governance & Nominating CommitteeUredare/Senior Project ManagerSwedish National Agency for Higher EducationSweden

Ex-officio

Dr. Christian Loucq Director GeneralInternational Vaccine Institute

Board of Trustees(as of December, 2013)

Annual Report 2013

29

Page 26: Annual report 2013 pdf

Dr. Robert E. Black - Chairman Professor - International HealthJohns Hopkins University, School of Hygiene & Public HealthU.S.A.

Dr. Duane J. Gubler Professor - Program on Emerging Infectious DiseasesDuke-NUS Graduate Medical School Singapore

Dr. Gagandeep Kang Professor and HeadThe Wellcome Trust Research LaboratoryIndia

Dr. Byoung S. Kwon Endowed InvestigatorNational Cancer CenterRepublic of Korea

Dr. Claudio F. Lanata Senior Researcher Instituto de Investigacion Nutricional - IIN, Peru Science Director US Navy Medical Research Unit 6 - NAMRU 6, Centro Medico NavalPeruProfessor School of Medicine, Peruvian University of Applied Sciences Peru

Dr. G. Balakrish Nair Executive DirectorTranslational Health Science and Technology InstituteIndia

Dr. Jacques Louis Professor [Emeritus] Faculty of Medicine University of Lausanne, SwitzerlandInstitut Pasteur, FranceDirector [Emeritus] Department of Parasitology and Mycology, Institut Pasteur, Paris(2003-2008)

Dr. Pearay L. Ogra Professor and Chairman [Emeritus]State University of New York at Buffalo Children's HospitalU.S.A.

Dr. David A. SackProfessor, Department of International Health Johns Hopkins University Bloomberg School of Public Health U.S.A.

Dr. Rho Hyun Seong Professor Seoul National University Republic of Korea

Dr. Peter Smith Professor London School of Hygiene & Tropical Medicine U.K.

Scientific Advisory Group

Annual Report 2013

30

Page 27: Annual report 2013 pdf

President and Chair of the Board

Prof. Cho Dong-sungProfessor Emeritus, Seoul NationalUniversity

Vice Presidents

Prof. Park Sang-ChulExecutive Vice President, Well AgingResearch Center, Samsung AdvancedInstitute of Technology

Dr. Rhee Byung-GeonPresident, Green Cross

Executive Director

Prof. Hong Seung HwanProfessor, Seoul National UniversityCollege of Natural Sciences

Executive Advisor

Prof. Cho Wan-KyooFormer President, Bioindustry Associationof Korea / Former President, SeoulNational University / Former Minister ofEducation

Chief Advisor

Prof. Park Sang-DaiVice-chair, Presidential AdvisoryCouncil on Science & Technology /Professor Emeritus, Seoul NationalUniversity

Legal Advisor

Mr. Choi Sang-YupLawyer, Former Minister of Justice /Vice Prosecutor-General

Advisors

Mr. Chae Hee-ByungPresident, Dongjin Chemical Co., Ltd.

Dr. Chae Young BogFormer Chairman, Gyeong Gi Bio-Center / Former Minister of Science &Technology

Dr. Chung Won-ShikChairman, The Yuhan Foundation /Former Prime Minister

Mr. Kang Choong HyunChairman, Samjin Globalnet Co., Ltd.

Mr. Kang Shin-HoChairman, Dong-A Socio Group

Mr. Kim JaisonPublisher, The Samtohsa / FoundingPresident of KSC / Former Speaker ofGeneral Assembly

Dr. Kim Kee-HyongHonorary President, Korea CeramicsCulture Promotion Society / FormerMinister of Science & Technology

Prof. Kim Nak DooProfessor Emeritus, Seoul NationalUniversity College of Pharmacy

Prof. Kim Sang-JooFormer President, the National Academyof Sciences, Republic of Korea

Prof. Kim Si JoongChairman, The Science-TechnologyForum / Former Minister of Science &Technology

Prof. Kwon E. HyockProfessor Emeritus & Former President,Seoul National University / FormerMinister of Education / Public Health /Environment

Dr. Lee Gil-yaPresident, Gachon Gil Foundation

Prof. Lee Ho-WangFormer President, the National Academyof Sciences, Republic of Korea

Mr. Lee Kyu HyungAdvisor, Samsung Research Institute,Former Ambassador of the Republic ofKorea in China and Russia, FormerDeputy Minister of MOFA

Prof. Lee Sang SupProfessor Emeritus, Seoul NationalUniversity College of Pharmacy

Mr. Lee Se-UngChairman, Shin Il Co. / Chairman, SeoulCyber University / Former President,Korea National Red Cross

Prof. Park Soo-GilChair Professor, Korea University /Former Permanent Representative ofthe Republic of Korea to the UN

Dr. Rhee Shang-HiChairman, Greenlife Intellectual Network,Former President, Korea Patent AttorneysAssociation / Former Minister of Science& Technology

Prof. Son Bong HoChairman, Korea Community SharingCampaign, Professor Emeritus, SeoulNational University

Prof. Yoo Chong-HaChair Professor, Graduate School ofInternational Studies, Sogang University/ Former President, Korea National RedCross / Former Minister of ForeignAffairs & Trade

Dr. Yoon Hong-GeunChairman & CEO, GENESIS BBQGroup

Prof. Yu Jae-CheonFormer President, Sangji University

Mr. Won Dae YunnChairman, Korea Fashion Association

Board of Trustees

Mr. Auh JinPresident, Ahn Gook Pharm.

Mr. Chi Chang-HoonPresident & CEO, Korean Air Lines

Dr. Choi DavisPresident, Korea Vaccine Co., Ltd.

Korea Support Committee for IVI (KSC)Established in 1998, the KSC is a nonprofit organization that mobilizes support in the Republic of Korea for IVI. The Committee consists of prominent leaders from government, industry, and academia in Korea. For more information, please visit: http://www.ivi.int/ksc.

Annual Report 2013

31

Page 28: Annual report 2013 pdf

Mr. Choo Hak-YooPresident, Dong Woo Chem. Corp,

Mr. Chun Hong JaeCEO, Chun Loss Prevention Co., Ltd.

Dr. Chung Chan BokPresident & CEO, Bioland

Prof. Chung Kil SaengFormer President, The Korean Academyof Science Technology; Emeritus &Former President, Konkuk University

Mr. Chung Pal DoChairman, Korealand Co.

Prof. Huh Kap BumProfessor Emeritus & Former Dean,Yonsei University College of Medicine

Mr. Jeffrey D. JohnsChairman, Partners for the FutureFoundation

Mr. Kang Shin JangPresident, Monaissance

Mr. Kim Duck SangCEO, Sartorius Korea Biotech Co.,Ltd.

Ms. Kim Eun-SunChairman, Boryung Pharm.

Prof. Kim Ki SeokProfessor, Seoul National UniversityCollege of Education

Mr. Kim Kyong HoChairman, Hankyong Instrument &ENG Co., Ltd

Prof. Kim KyungjinProfessor, Seoul National UniversityCollege of Natural Science

Prof. Kim Sun YoungProfessor, Seoul National UniversityCollege of Natural Sciences

Mr. Kim Young-KeeExecutive Vice President / CSR TeamLeader, LG

Mr. Kim Peter PumsooChairman, InnoS&S Co., Ltd.

Mr. Kim Sun KiPresident, Bio-Medical Science Co.,Ltd

Mr. Kim Young JePresident & CEO, Sky 72 Golf Club

Mr. Lee Doung YoungCEO, Marketing Production, SeoulDairy Cooperative

Mr. Lee Jae HooSenior Partner, Kim & Chang

Mr. Lee In JungPresident & CEO, Taein Co., Ltd.

Mr. Lee In serkCEO, SK Chemical Life Science Biz

Ms. Lee Kyung JaChairman, Association of Research &Development for Experience Education

Mr. Lee Suk HoFormer President, Ulsan BroadcastingCorp.

Prof. Lee Young SoonProfessor Emeritus, Seoul NationalUniversity

Dr. Limb Thok-KyuChairman, Magazine "Diplomacy"

Mr. Moon Kyung AhnPresident & CEO, Volvik

Dr. Oh Tae KwangPresident, Korea Research Institute ofBioscience and Biotechnology

Prof. Paek DomyungProfessor, Seoul National UniversityGraduate School of Public Health

Prof. Park Kyung AProfessor, Yonsei University Collegeof Medicine

Mr. Park Nam SeoCEO, Sanha Engineering & Construction Co.

Prof. Song Jin WonProfessor, Korea University College ofMedicine

Mr. Stanley ChoCEO, Smart Optech

Mr. Shin Hyun IlChairman, Bomoon Co.

Dr. Yang Yoon SunCEO & President, MEDIPOST

Prof. Yim Jeong-binChair Professor, Soon Chun HyangUniversity

Mr. Yoo Myung HwanChairman, Global Yoo Myung Co., Ltd.

Dr.Yoon Eun KeyChair Professor, aSSIST(Seoul Schoolof Integrated Science & Technology)

Dr. Yoon Kang JunPresident, St. Peter’s Hospital

Mr. You Kyung NamCEO, Liftec Co., Ltd.

Auditors

Mr. Kim Yong-WonPartner, Samil PricewaterhouseCoopers

Prof. Seong Rho HyunDean for Research Affairs, & Professor,Seoul National University College ofNatural Sciences

32

Page 29: Annual report 2013 pdf

Core funding to IV I is provided by the governmentsof the Republic of Korea and Sweden. Public-and private-sector organizations and individualsalso provide support, both monetary and in-kind,for the Institute’s research and programs.Prominent organizations and individuals in Koreaprovide support due to efforts of the KoreaSupport Committee for IV I (KSC). While thereare too many donors to list here, their generosityis deeply appreciated. To see the full list of IV Idonors, please refer to the IVI website,http://www.ivi.int.

Bill & Melinda Gates Foundation

Catholic University of Korea

Chosun Ilbo

Community Chest of Korea

Export-Import Bank of Korea

Federal Ministry of Education and Research, Germany (BMBF)

GlaxoSmithKline Biologicals

Inviragen, Inc.

Kia Motors

Korea Exchange Bank Foundation

Korea Health Industry Development Institute

Korea Research Institute of Bioscience and Biotechnology (KRIBB)

Korea Support Committee for IVI (KSC), Republic of Korea

LG Electronics

Merck & Co.

Ministry of Education (MOE), Republic of Korea

Ministry of Foreign Affairs (MOFA), Republic of Korea

Ministry of Unification (MOU), Republic of Korea

National Research Foundation of Korea

NC Soft Corporation

Pfizer, Inc.

Richmont Group

Sanofi Pasteur

Swedish International Development Cooperation Agency (Sida)

Thrasher Foundation

Yanghyun Foundation

Major Donors in 2013

Annual Report 2013

33

Page 30: Annual report 2013 pdf

Academy of Medical Sciences, DemocraticPeople’s Republic of KoreaAga Khan University, PakistanAgence de Medecine Preventive (AMP), FranceAjou University, Republic of KoreaApplied Strategies, USA Armauer Hansen Research Institute (AHRI),EthiopiaAVIR Green Hills Biotechnology AGBandim Health ProjectBangladesh Institute of Child Health, BangladeshBeams Biotechnology Co., Ltd.Bernhard Nocht Institute for Tropical Medicine,GermanyBharat Biotech, India BioFarma, IndonesiaBio-Korea, Republic of KoreaBusan University, Republic of KoreaCaritas, GermanyCatholic University, Republic of KoreaCelltrion, Republic of KoreaChonbuk National University, Republic of KoreaChonnam University, Republic of KoreaChristian Medical College, IndiaChungnam National University, Republic ofKoreaCity District Government of Karachi, PakistanCoalition against Typhoid Directorate of Health Services, Department ofHealth and Family Welfare, State Governmentof Orissa, IndiaDistrict Public Health Offices of Lalitpur andBakhtapur, NepalDuke University Medical Center, USA Emory University, USAEthiopian Health and Nutrition Research Institute,Ethiopia EuBiologics, Republic of KoreaEwha Womans University, Republic of KoreaKorea Food and Drug Administration, Republicof KoreaFred Hutchinson Cancer Research Center GAVI, SwitzerlandGreen Cross, Republic of KoreaGreen Tree Foundation, Republic of KoreaGroup for Technical Assistance, NepalHallym University, Republic of KoreaHanyang University, Republic of Koreaicddr,b, BangladeshIncepta Pharmaceuticals Ltd., BangladeshIndian Council of Medical Research, India

Institut Pasteur, KoreaInstitut Pasteur, SenegalInstitut Superieur des Sciences de la Population(ISSP), Burkina FasoInstituto Butantan, BrazilJohns Hopkins University - International VaccineAccess Center (IVAC), USAKangwon National University, Republic ofKoreaKenya Medical Research Institute, KenyaKilimanjaro Christian Medical Centre, TanzaniaKonkuk University, Republic of Korea Korea Center for Disease Control, Republic ofKoreaKorea Institute of Tuberculosis, Republic ofKorea Korea National Institute of Health (KNIH),Republic of KoreaKorea Research Institute of Bioscience andBiotechnology (KRIBB), Republic of KoreaKumasi Centre for Collaborative Research inTropical Medicine, GhanaKyunghee University Mahidol University, ThailandMerck & Co., USAMetrosalud ESE / Unidad Hospitalaria communaSanta Cruz, Medellin, ColombiaMinistries of Health (Ethiopia, Kazakhstan,Kyrgyzstan, Mongolia, Sudan)Ministries of Public Health (Brazil, Colombia,Thailand)Ministry of Health and Population, NepalMinistry of Health of Sindh Province, PakistanMinistry of Tourism and Civil Aviation, NepalMITRA Samaj, NepalNational Center for Communicable Diseases,Ulaanbaatar, MongoliaNational Institute for Communicable Diseases(NICD), South AfricaNational Institute of Cholera & Enteric Diseases(NICED), IndiaNational Institute of Hygiene and Epidemiology(NIHE), Vietnam National Institutes of Health (NIH), USANihon University, Japan Oromia Regional Health Bureau, EthiopiaOxford Economic Forecasting, United KingdomPan American Health Organization (PAHO)Patan Hospital, NepalPATH, USAPohang University of Science and Technology

(POSTECH), Republic of KoreaPrograma de Estudio y Control de EnfermedadesTropicales (PECET), Universidad de Antioquia, Medellin, ColombiaRegional Medical Research Centre, Bhubaneswar,Orissa, IndiaSabin Vaccine Institute, USASanofi Pasteur, FranceScientific Research Center for EpidemiologicalExpertise and Monitoring, Almaty, KazakhstanSecretaria de Salud, Medellin, ColombiaSejong University, Republic of KoreaSeoul National University, Republic of KoreaShantha Biotechnics, IndiaSK Chemicals, Republic of KoreaStanford University, USATakeda Pharmaceutical Company Limited, JapanTransgovernment Enterprise against PandemicInfluenza of Korea (TEPIK)Trust for Vaccines and Immunization (TVI), PakistanUNICEF, NepalUnited States Centers for Disease Control andPrevention (CDC), USAUniversity of Alabama at Birmingham, USAUniversity of Antananarivo, MadagascarUniversity of Antioquia, ColumbiaUniversity of Florida, USAUniversity of Gezira, SudanUniversity of Gothenburg, SwedenUniversity of Melbourne, AustraliaUniversity of Ouagadougou, Burkina FasoUniversity of Queensland, AustraliaUniversity of Vermont, USAUniversity of Virginia, USAUniversity of Wisconsin, USAVaBiotech, VietnamVaccine Technologies, Inc. (VTI)Walter Reed Army Institute of Research (WRAIR),USAWashington University, USAWellcome Trust Sanger Institute, UKWHO Initiative for Vaccine Research (IVR)WHO Programme for Immunization PreventableDiseases (IPD), NepalWHO Regional Office for Europe (EURO)WHO Regional Office for South-East Asia(SEARO)WHO Regional Office for the Western Pacific(WPRO)World Health Organization (WHO)Yonsei University, Republic of Korea

•••••

•••••

•••••••••••

•••

•••

•••

••••••••••

•••

••

••••

••••

•••••

••••••••

•••

••••••••

•••••••••••••••••••

••••

••

••

Major Collaborators in 2013

Annual Report 2013

34

Page 31: Annual report 2013 pdf

2013 IVI Scientific Publications

Annual Report 2013

1. Adolph TE, Tomczak MF, Niederreiter L, Ko HJ, Bock J,Martinez-Naves E, Glickman JN, Tschurtschenthaler M,Hartwig J, Hosomi S, Flak MB, Cusick JL, Kohno K,Iwawaki T, Billmann-Born S, Raine T, Bharti R, Lucius R,Kweon MN, Marciniak SJ, Choi A, Hagen SJ, Schreiber S,Rosenstiel P, Kaser A, Blumberg RS. Paneth cells as a site oforigin for intestinal inflammation. Nature 2013/Nov/14;503(7475): 272-6.

2. Ali M, Kim DR, Yunus M, Emch M. Time series analysis ofcholera in Matlab, Bangladesh, during 1988-2001. J HealthPopul Nutr 2013/Mar; 31(1): 11-9.

3. Ali M, Sur D, You YA, Kanungo S, Sah B, Manna B, PuriM, Wierzba TF, Donner A, Nair GB, Bhattacharya SK,Dhingra MS, Deen JL, Lopez AL, Clemens J. Herd protectionby a bivalent killed whole-cell oral cholera vaccine in the slumsof Kolkata, India. Clin Infect Dis 2013/Apr; 56(8): 1123-31.

4. Al-Mamun A, Mily A, Sarker P, Tiash S, Navarro A, AkterM, Talukder KA, Islam MF, Agerberth B, GudmundssonGH, Cravioto A, Raqib R. Treatment with phenylbutyrate in apre-clinical trial reduces diarrhea due to enteropathogenicEscherichia coli: link to cathelicidin induction. Microbes Infect2013/Nov; 15(13): 939-50.

5. Amarasinghe A, Black S, Bonhoeffer J, Carvalho SM,Dodoo A, Eskola J, Larson H, Shin S, Olsson S, BalakrishnanMR, Bellah A, Lambach P, Maure C, Wood D, Zuber P,Akanmori B, Bravo P, Pombo M, Langar H, Pfeifer D,Guichard S, Diorditsa S, Hossain MS, Sato Y. Effectivevaccine safety systems in all countries: a challenge for moreequitable access to immunization. Vaccine 2013/Apr; 31 Suppl2: B108-14.

6. An SJ, Jung UJ, Choi MS, Chae CK, Oh GT, Park YB.Functions of monocyte chemotactic protein-3 in transgenicmice fed a high-fat, high-cholesterol diet. J Microbiol Biotechnol2013/Mar; 23(3): 405-13.

7. Bhattacharya SK, Sur D, Ali M, Kanungo S, You YA,Manna B, Sah B, Niyogi SK, Park JK, Sarkar B, Puri MK, KimDR, Deen JL, Holmgren J, Carbis R, Dhingra MS, DonnerA, Nair GB, Lopez AL, Wierzba TF, Clemens JD. 5 yearefficacy of a bivalent killed whole-cell oral cholera vaccine inKolkata, India: a cluster-randomised, double-blind, placebo-controlled trial. Lancet Infect Dis 2013/Dec; 13(12): 1050-6.

8. Bhattacharya SK, Sur D, Dutta S, Kanungo S, Ochiai RL,Kim DR, Anstey NM, von Seidlein L, Deen J. Vivax malariaand bacteraemia: a prospective study in Kolkata, India. Malar J2013; 12: 176.

9. Biggs HM, Hertz JT, Munishi OM, Galloway RL, Marks F,Saganda W, Maro VP, Crump JA. Estimating leptospirosisincidence using hospital-based surveillance and a population-based health care utilization survey in Tanzania. PLoS Negl TropDis 2013/Dec/05; 7(12): e2589.

10. Birkett AJ, Moorthy VS, Loucq C, Chitnis CE, KaslowDC. Malaria vaccine R&D in the Decade of Vaccines:breakthroughs, challenges and opportunit ies. Vaccine2013/Apr; 31 Suppl 2: B233-43.

11. Bwire G, Malimbo M, Maskery B, Kim YE, Mogasale V,Levin A. The burden of cholera in Uganda. PLoS Negl Trop Dis2013/Dec/05; 7(12): e2545.

12. Caini S, Beck NS, Yacouba H, Maiga I, Chaibou I, HinsaI, Adakal A, Issoufou A, Kim SH, Pezzoli L. From Agadez toZinder: estimating coverage of the MenAfriVacTM conjugatevaccine against meningococcal serogroup A in Niger, September2010 - January 2012. Vaccine 2013/Mar/15; 31(12): 1597-603.

13. Capeding MR, Bravo L, Santos J, Kilgore PE, Kim SA,Balter I, Hubler R, Ye J, Moscariello M. Prospective SurveillanceStudy of Invasive Pneumococcal Disease Among UrbanChildren in the Philippines. Pediatr Infect Dis J 2013; 32(10):e383-e389.

14. Chang SY, Lee SN, Yang JY, Kim DW, Yoon JH, Ko HJ,Ogawa M, Sasakawa C, Kweon MN. Autophagy controls anintrinsic host defense to bacteria by promoting epithelial cellsurvival: a murine model. PLoS One 2013/Nov/19; 8(11):e81095.

15. Chang SY, Song JH, Guleng B, Cotoner CA, Arihiro S,Zhao Y, Chiang HS, O’Keeffe M, Liao G, Karp CL, KweonMN, Sharpe AH, Bhan A, Terhorst C, Reinecker HC.Circulatory antigen processing by mucosal dendritic cellscontrols CD8(+) T cell activation. Immunity 2013/Jan/24; 38(1):153-65.

16. Chao DL, Longini IM Jr, Halloran ME. The effects ofvector movement and distribution in a mathematical model ofdengue transmission. PLoS One 2013/Oct/21; 8(10): e76044.

17. Chu H, Park SM, Cheon IS, Park MY, Shim BS, Gil BC,Jeung WH, Hwang KJ, Song KD, Hong KJ, Song M, JeongHJ, Han SH, Yun CH. Orientia tsutsugamushi InfectionInduces CD4+ T Cell Activation via Human Dendritic CellActivity. J Microbiol Biotechnol 2013/Aug; 23(8): 1159-66.

18. Delgado G, Souza V, Morales R, Cerritos R, Gonzalez-Gonzalez A, Mendez JL, Vazquez V, Cravioto A. Genetic

35

Page 32: Annual report 2013 pdf

Annual Report 2013

Characterization of Atypical Citrobacter freundii. PLoS One2013/Sep/12; 8(9): e74120.

19. Douglas DL, DeRoeck DA, Mahoney RT, Wichmann O.Will dengue vaccines be used in the public sector and if so,how? Findings from an 8-country survey of policymakers andopinion leaders. PLoS Negl Trop Dis 2013; 7(3): e2127.

20. Frickmann H, Dekker D, Boahen K, Acquah S, SarpongN, Adu-Sarkodie Y, Schwarz NG, May J, Marks F, PoppertS, Wiemer DF, Hagen RM. Increased detection of invasiveenteropathogenic bacteria in pre-incubated blood culturematerials by real-time PCR in comparison with automatedincubation in Sub-Saharan Africa. Scand J Infect Dis 2013/Aug;45(8): 616-22.

21. Frickmann H, Hanle A, Essig A, Dekker D, Boahen K,Acquah S, Sarpong N, Adu-Sarkodie Y, Schwarz NG, MayJ, Marks F, Hagen RM, Poppert S. Fluorescence in situhybridization (FISH) for rapid identification of Salmonella spp.from agar and blood culture broth-an option for the tropics? IntJ Med Microbiol 2013/Jul; 303(5): 277-84.

22. Gordon A, Kuan G, Mercado JC, Gresh L, Aviles W,Balmaseda A, Harris E. The Nicaraguan pediatric denguecohort study: incidence of inapparent and symptomatic denguevirus infections, 2004-2010. PLoS Negl Trop Dis 2013/Sep/26;7(9): e2462.

23. Guzman MG, Alvarez M, Halstead SB. Secondary infectionas a risk factor for dengue hemorrhagic fever/dengue shocksyndrome: an historical perspective and role of antibody-dependent enhancement of infection. Arch Virol 2013/Jul;158(7): 1445-59.

24. Halstead SB. Dengue: the syndromic basis to pathogenesisresearch. Inutility of the 2009 WHO case definition. Am J TropMed Hyg 2013/Feb; 88(2): 212-5.

25. Halstead SB. Dengue Vascular Permeability Syndrome:What, No T Cells? Clin Infect Dis 2013/Mar; 56(6): 900-1.

26. Hong EH, Chang SY, Lee BR, Kim YS, Lee JM, KangCY, Kweon MN, Ko HJ. Blockade of Myd88 signaling inducesantitumor effects by skewing the immunosuppressive functionof myeloid-derived suppressor cells. Int J Cancer 2013/Jun/15;132(12): 2839-48.

27. Hong EH, Chang SY, Lee BR, Pyun AR, Kim JW, KweonMN, Ko HJ. Intratumoral injection of attenuated Salmonellavaccine can induce tumor microenvironmental shift fromimmune suppressive to immunogenic. Vaccine 2013/Feb/27;

31(10): 1377-84.

28. HS Wee. The Effect of School Immunization Law on AdultIncome: The American Case. Korea Review of Applied Economics2013; 15(3): 5-37.

29. Islam A, Labbate M, Djordjevic SP, Alam M, Darling A,Melvold J, Holmes AJ, Johura FT, Cravioto A, Charles IG,Stokes HW. Indigenous Vibrio cholerae strains from a non-endemic region are pathogenic. Open Biol 2013/Feb; 3(2):120181.

30. Izurieta HS, Zuber P, Bonhoeffer J, Chen RT, SankohgO, Laserson KF, Sturkenboom M, Loucq C, Weibel D, DoddC, Black S. Roadmap for the international collaborativeepidemiologic monitoring of safety and effectiveness of newhigh priority vaccines. Vaccine 2013/Aug/02; 31(35): 3623-7.

31. Kaljee LM, Pach A, Thriemer K, Ley B, Ali SM, JiddawiM, Puri M, von Seidlein L, Deen J, Ochiai L, Wierzba T,Clemens J. Utilization and accessibility of healthcare on pembaisland, Tanzania: implications for health outcomes and diseasesurveillance for typhoid Fever. Am J Trop Med Hyg 2013/Jan;88(1): 144-52.

32. Kaljee LM, Pach A, Thriemer K, Ley B, Jiddawi M, PuriM, Ochiai L, Wierzba T, Clemens J, Ali SM. Desirability for atyphoid fever vaccine among rural residents, Pemba Island,Tanzania. Vaccine 2013/Jun/24; 31(29): 2994-9.

33. Kang SS, Yang JS, Kim KW, Yun CH, Holmgren J,Czerkinsky C, Han SH. Anti-bacterial and anti-toxic immunityinduced by a killed whole-cell-cholera toxin B subunit choleravaccine is essential for protection against lethal bacterialinfection in mouse pulmonary cholera model. Mucosal Immunol2013/Jul; 6(4): 826-37.

34. Khan IA, Saha A, Chowdhury F, Khan AI, Uddin MJ,Begum YA, Riaz BK, Islam S, Ali M, Luby SP, Clemens JD,Cravioto A, Qadri F. Coverage and cost of a large oral choleravaccination program in a high-risk cholera endemic urbanpopulation in Dhaka, Bangladesh. Vaccine 2013/Dec/09;31(51): 6058-64.

35. Khanam F, Sheikh A, Sayeed MA, Bhuiyan MS, ChoudhuryFK, Salma U, Pervin S, Sultana T, Ahmed D, Goswami D,Hossain ML, Mamun KZ, Charles RC, Brooks WA, CalderwoodSB, Cravioto A, Ryan ET, Qadri F. Evaluation of a Typhoid/Paratyphoid Diagnostic Assay (TPTest) Detecting Anti-Salmonella IgA in Secretions of Peripheral Blood Lymphocytesin Patients in Dhaka, Bangladesh. PLoS Negl Trop Dis2013/Jul/11; 7(7): e2316.

36

Page 33: Annual report 2013 pdf

36. Kim EH, Lee JH, Pascua PN, Song MS, Baek YH, KwonHI, Park SJ, Lim GJ, Decano A, Chowdhury MY, Seo SK,Song MK, Kim CJ, Choi YK. Prokaryote-expressed M2eprotein improves H9N2 influenza vaccine eff icacy andprotection against lethal influenza A virus in mice. Virol J2013/Apr/03; 10: 104.

37. Kim JY, Choi Y, Nguyen HH, Song MK, Chang J. Mucosalimmunization with recombinant adenovirus encoding solubleglobular head of hemagglutinin protects mice against lethalinfluenza virus infection. Immune Netw 2013/Dec; 13(6): 275-82.

38. Kim SH, Kim JY, Choi Y, Nguyen HH, Song MK, ChangJ. Mucosal vaccination with recombinant adenovirus encodingnucleoprotein provides potent protection against influenza virusinfection. PLoS One 2013/Sep/25; 8(9): e75460.

39. Kmush B, Wierzba T, Krain L, Nelson K, Labrique AB.Epidemiology of hepatitis E in low- and middle-income countriesof Asia and Africa. Semin Liver Dis 2013/Feb; 33(1): 15-29.

40. Kochhar S, Rath B, Seeber LD, Rundblad G, KhamesipourA, Ali M. Introducing new vaccines in developing countries.Expert Rev Vaccines 2013/Dec; 12(12): 1465-78.

41. Kothari S, Kothari N, Kim JA, Lee E, Yoon YK, An SJ,Jones C, Choe WS, Carbis R. A novel method for purificationof Vi capsular polysaccharide produced by Salmonella entericasubspecies enterica serovar Typhi. Vaccine 2013/Oct/01;31(42): 4714-9.

42. Lantagne D, Balakrish Nair G, Lanata CF, Cravioto A.The Cholera Outbreak in Haiti: Where and how did it begin?Curr Top Microbiol Immunol 2013/May/22;

43. Lee JY, Kim HS, Baek IW, Back JM, Han MR, Kong SY,Kim JH, Kirchdoerfer RN, Kim JO, Cooper MD, Wilson IA,Kim HJ, Han BW. Overexpression, crystall ization andpreliminary X-ray crystallographic analysis of the variablelymphocyte receptor 2913 ectodomain fused with internalin B.Acta Crystallogr Sect F Struct Biol Cryst Commun 2013/Jan/01;69(Pt 1): 39-41.

44. Lee KM, Choi YJ, Shin SH, Choi MK, Song HJ, Kim HC,Klein TA, Richards AL, Park KH, Jang WJ. Spotted fevergroup rickettsia closely related to Rickettsia monacensisisolated from ticks in South Jeolla province, Korea. MicrobiolImmunol 2013/Jul; 57(7): 487-95.

45. Loucq C. Vaccines today, vaccines tomorrow: a perspective.Clin Exp Vaccine Res 2013/Jan; 2(1): 4-7.

46. Mahalingam S, Herring BL, Halstead SB. Call to actionfor dengue vaccine failure. Emerg Infect Dis 2013/Aug; 19(8):1335-7.

47. Maskery B, DeRoeck D, Levin A, Kim YE, Wierzba TF,Clemens JD. Strategy, demand, management, and costs of aninternational cholera vaccine stockpile. J Infect Dis 2013/Nov/01; 208(Suppl 1): S15-22.

48. Mishra J, Dey A, Singh N, Somvanshi R, Singh S. Evaluationof toxicity & therapeutic efficacy of a new liposomal formulationof amphotericin B in a mouse model. Indian J Med Res 2013/Apr; 137(4): 767-76.

49. Mogasale V, Levin A, Maskery B, DeRoeck D, Kim YE,Clemens J, Lopez AL, Burgess C, Wierzba T. Oral choleravaccines to control endemic disease: an economic andepidemiological modelling analysis. Lancet 2013/Oct/20;382(suppl 1): 6.

50. Montoya M, Gresh L, Mercado JC, Williams KL, VargasMJ, Gutierrez G, Kuan G, Gordon A, Balmaseda A, HarrisE. Symptomatic versus inapparent outcome in repeat denguevirus infections is influenced by the time interval betweeninfections and study year. PLoS Negl Trop Dis 2013/Aug/08;7(8): e2357.

51. Na HN, Kim KH, Song MK, Park HL, Lee EY, Shim SH,Park S, Nam JH. Immunogenicity and safety of H1N1 influenzahemagglutinin protein expressed in a baculovirus system.Microbiol Immunol 2013/Sep; 57(9): 660-4.

52. Noh Y, Shim BS, Cheon IS, Rho S, Kim HJ, Choi Y,Kang CY, Chang J, Song MK, Kim JO. Neonatal immunizationwith respiratory syncytial virus glycoprotein fragment inducesprotective immunity in the presence of maternal antibodies inmice. Viral Immunol 2013/Aug; 26(4): 268-76.

53. Pach A, Tabbusam G, Khan MI, Suhag Z, Hussain I,Hussain E, Mumtaz U, Haq IU, Tahir R, Mirani A, YousafzaiA, Sahastrabuddhe S, Ochiai RL, Soofi S, Clemens JD,Favorov MO, Bhutta ZA. Formative Research and Developmentof an Evidence-Based Communication Strategy: The Introductionof Vi Typhoid Fever Vaccine Among School-Aged Children inKarachi, Pakistan. J Health Commun 2013/Jan; 18(3): 306-24.

54. Park YJ, Song B, Kim YS, Kim EK, Lee JM, Lee GE, KimJO, Kim YJ, Chang WS, Kang CY. Tumor microenvironmentalconversion of natural killer cells into myeloid-derived suppressorcells. Cancer Res 2013/Sep/15; 73(18): 5669-81.

55. Punjabi NH, Agtini MD, Ochiai RL, Simanjuntak CH,

37

Page 34: Annual report 2013 pdf

Lesmana M, Subekti D, Oyofo BA, von Seidlein L, Deen J,Shin S, Acosta C, Wangsasaputra F, Pulungsih SP, SarosoS, Suyeti S, R S, Sudarmono P, Syarurachman A, SuwandonoA, Arjoso S, Beecham HJ 3rd, Corwin AL, Clemens JD.Enteric fever burden in North Jakarta, Indonesia: a prospective,community-based study. J Infect Dev Ctries 2013/Nov/15; 7(11):781-7.

56. Ryu JH, Yoo JY, Kim MJ, Hwang SG, Ahn KC, Ryu JC,Choi MK, Joo JH, Kim CH, Lee SN, Lee WJ, Kim J, ShinDM, Kweon MN, Bae YS, Yoon JH. Distinct TLR-mediatedpathways regulate house dust mite-induced allergic disease inthe upper and lower airways. J Allergy Clin Immunol 2013/Feb;131(2): 549-61.

57. Sahastrabuddhe S, Carbis R, Wierzba TF, Leon OchiaiR. Increasing rates of Salmonella Paratyphi A and the currentstatus of its vaccine development. Expert Rev Vaccines 2013/Sep; 12(9): 1021-31.

58. Saletti G, Cuburu N, Yang JS, Dey A, Czerkinsky C.Enzyme-linked immunospot assays for direct ex vivomeasurement of vaccine-induced human humoral immuneresponses in blood. Nat Protoc 2013/Jun; 8(6): 1073-87.

59. Shim BS, Choi JA, Song HH, Park SM, Cheon IS, JangJE, Woo SJ, Cho CH, Song MS, Kim H, Song KJ, Lee JM,Kim SW, Song DS, Choi YK, Kim JO, Nguyen HH, Kim DW,Bahk YY, Yun CH, Song MK. Sublingual administration ofbacteria-expressed influenza virus hemagglutinin 1 (HA1)induces protection against infection with 2009 pandemic H1N1influenza virus. J Microbiol 2013/Feb; 51(1): 130-5.

60. Shim BS, Choi Y, Cheon IS, Song MK. Sublingual deliveryof vaccines for the induction of mucosal immunity. ImmuneNetw 2013/Jun/13; 13(3): 81-5.

61. Tam CC, Tissera H, de Silva AM, De Silva AD, MargolisHS, Amarasinge A. Estimates of dengue force of infection inchildren in Colombo, Sri Lanka. PLoS Negl Trop Dis 2013/Jun;7(6): e2259.

62. Tsai WY, Lai CY, Wu YC, Lin HE, Edwards C, JumnainsongA, Kliks S, Halstead S, Mongkolsapaya J, Screaton GR,Wang WK. High-avidity and potently neutralizing cross-reactivehuman monoclonal antibodies derived from secondary denguevirus infection. J Virol 2013/Dec; 87(23): 12562-75.

63. Wahed T, Kaukab SS, Saha NC, Khan IA, Khanam F,Chowdhury F, Saha A, Khan AI, Siddik AU, Cravioto A,Qadri F, Uddin J. Knowledge of, attitudes toward, andpreventive practices relating to cholera and oral cholera vaccineamong urban high-risk groups: findings of a cross-sectionalstudy in Dhaka, Bangladesh. BMC Public Health 2013/May/19;13: 242.

64. Woo SJ, Im J, Jeon JH, Kang SS, Lee MH, Yun CH,Moon EY, Song MK, Kim HH, Han SH. Induction of BAFFexpression by IFN-gamma via JAK/STAT signaling pathways inhuman intestinal epithelial cells. J Leukoc Biol 2013/Mar; 93(3):363-8.

65. Yang H, Ko HJ, Yang JY, Kim JJ, Seo SU, Park SG,Choi SS, Seong JK, Kweon MN. Interleukin-1 PromotesCoagulation, Which Is Necessary for Protective Immunity in theLung Against Streptococcus pneumoniae Infection. J Infect Dis2013/Jan/01; 207(1): 50-60.

66. You YA, Ali M, Kanungo S, Sah B, Manna B, Puri M,Nair GB, Bhattacharya SK, Convertino M, Deen JL, LopezAL, Wierzba TF, Clemens J, Sur D. Risk map of cholerainfection for vaccine deployment: the eastern Kolkata case.PLoS One 2013/Aug/02; 8(8): e71173.

Annual Report 2013

38

Page 35: Annual report 2013 pdf

Financial Summary

Annual Report 2013

39

Note: The above financial statement is an excerpt from the IVI’s audited financial statements, which are audited by Samil PricewaterhouseCoopers. TheInternational Vaccine Institute is an international nonprofit organization. Contributions to the IVI are tax-exempt under US IRS code 501(c) (3).

REVENUE

Bill & Melinda Gates Foundation (BMGF)

Government of the Republic of Korea*

Swedish International Development Cooperation Agency (Sida)

Corporations / Individuals / Others

Korean Government** Laboratory Support

Investments (Interest Income)

Total Income

2013

10,591,248

1,967,362

1,705,861

4,647,797

785,428

7,507

19,705,203

54%

10%

9%

24%

4%

0%

100%

2012

9,076,267

2,193,155

616,313

5,897,021

144,747

17,927,503

EXPENSES

Program Services

Laboratory Support

Management & General

Communication & Advocacy

Total Expense

Foreign Exchange Gain (Loss)

Net Surplus (Deficit)

2013

15,838,109

1,529,379

2,959,935

897,756

21,225,180

(52,373)

(1,572,350)

2012

14,933,906

2,024,945

4,396,482

1,071,617

22,426,950

78,360

(4,421,087)

* Figures are presented in US dollars.

ASSETS

Cash and Cash Equivalents

Bank Deposits

Other Current Assets

Other assets

Total Assets

2013

9,576,112

26,597,341

1,031,647

772,608

37,977,708

2012

6,867,107

26,100,742

1,406,568

971,327

35,345,744

LIABILITIES AND NET ASSETS

Grant Funds-Deferred support

Other Current Liabilities

Other Liabilities

Total Liabilities and Net Assets

2013

29,632,085

1,277,424

7,068,199

37,977,708

2012

25,631,138

1,074,057

8,640,549

35,345,744

51%

12%3%

33%

1%

54%

10%

9%

24%

4%

2013 SOURCES OF REVENUE

2013 EXPENSE ALLOCATION

66%9%

20%

5%

75%

7%

14%

4%

Bill & Melinda Gates Foundation (BMGF)Government of the Republic of KoreaSwedish International Development Cooperation Agency (Sida)Corporations / Individuals / OthersKorean Government Laboratory SupportInvestments (Interest Income)

Program Services Laboratory SupportManagement & GeneralCommunication & Advocacy

51%

12%

3%

33%

0%

1%

100%

*Core fund support **Ministry of Education/National Research Foundation of Korea

Page 36: Annual report 2013 pdf

State Parties and/or Signatories to IVI’s Establishment Agreement

Annual Report 2013

4400

Page 37: Annual report 2013 pdf