Upload
others
View
5
Download
0
Embed Size (px)
Citation preview
ANNUAL REPORT 2015
SATVI ANNUAL REPORT 2015
contentsVision and Mission 2
Directors Foreword 3
About SATVI 4
Governance: Executive Committee and Senior Clinical Research Team 5
Highlights 2015 9
Research Outputs 22
Postgraduate Students and Postdoctoral Fellows 24
SATVI Staff 25
Community Involvement 27
Community Advisory Board 30
Funders 31
Collaborators 32
our
vision
our
missionA World Without TB Innovative and High Quality
TB Vaccine Research in Africa to Impact the Global Epidemic
vision &
mission
SATVI ANNUAL REPORT 2015 3
2015 was a year of extraordinary activity for SATVI. The
clinical and laboratory teams completed three Phase
1-2 trials of novel TB vaccines in adult and infant study
populations; finished enrolment in two large Phase 2 TB
vaccine trials, including a proof of concept efficacy trial of
the GSK M72 candidate vaccine in TB-infected adults and a
Prevention of Infection (POI) trial of the Sanofi H4 candidate
vaccine and BCG in adolescents; and started recruitment
for clinical trials of a recombinant BCG vaccine (VPM-1002)
in newborns; a live attenuated Mycobacterium tuberculosis
vaccine (MTBVAC) in adults and infants; and an adjuvanted
subunit vaccine (ID93+GLA-SE) in recently treated TB
patients.
Our research remains firmly focused on development of
a new TB vaccine that is safe and effective in infants,
children, and adults, including persons who are HIV
infected. At the same time, we have made a concerted
effort to diversify our TB research portfolio. After a lengthy
preparation period, we enrolled our first participants into an
AIDS Clinical Trial Group (ACTG) household contact study
of multidrug-resistant TB patients. The study marks the
first of several TB diagnostic and therapeutic studies in the
SATVI pipeline.
SATVI’s research outputs continue to increase, with a total
of 29 papers published by SATVI authors in 2015, including
the report of a first-in-human trial of the adjuvanted subunit
vaccine H56:IC31 (Staten Serum Institut).
The year ended on a high note, with the award of a multi-
million dollar grant for a clinical trial that will test a screen
and treat strategy to target preventive therapy for persons
with a transcriptomic signature of risk for TB disease.
CORTIS (The Correlate of Risk Targeted Intervention
Study) will start in mid-2016. We also led a successful
application to a joint SAMRC-NIAID call to establish the
Clinical Research Unit for Advancement of Tuberculosis
Biomarker-Targeted Interventions, part of the new RePORT
SA network.
We also bade farewell to Dr Zameer Brey, who joined the Bill
& Melinda Gates Foundation’s South Africa Office, and we
welcome Dr Masooda Kaskar, who joins us from Novartis to
take up the reins of the COO position in 2016.
A big ‘thank you’ goes to the Breede Valley community in
which we work, our study participants and their families,
who are deeply invested in our research to prevent and
cure TB. The achievements of the past year would also not
have been possible without the help of our many local and
international partners, and we begin 2016 in the same spirit
of active and equal collaboration towards a shared goal –
“a World without TB”.
Mark Hatherill
Director
directors foreword4
SATVI ANNUAL REPORT 20154
about satviWHO WE ARE
The South African Tuberculosis Vaccine Initiative
(SATVI) is a tuberculosis research group with a
research focus that spans several disciplines
including paediatrics, infectious diseases,
epidemiology, public health, immunology, systems
biology and clinical sciences. SATVI has a large
and well-developed clinical field site in the Boland
Overberg region, with the core on the premises of
the Brewelskloof TB Hospital in Worcester, from
where most clinical/epidemiological studies and
clinical trials of new TB vaccines are conducted.
The Clinical Trials work is led by SATVI Director,
Associate Professor Mark Hatherill; and the
Immunology and Laboratory-based work is led by
Associate Professor Tom Scriba.
OUR WORK
SATVI was launched in 2001 at the University
of Cape Town (UCT) and has developed into a
sophisticated world class TB vaccine clinical
research centre with state of the art immunology
laboratories located within the Institute of
Infectious Disease and Molecular Medicine (IDM)
of the University of Cape Town, and at the
Worcester field site.
SATVI is regarded as a leader in tuberculosis
vaccine clinical research worldwide and is the
largest dedicated tuberculosis vaccine research
group on the African continent. Our laboratories are
accredited, which means adherence to the highest
international standards.
OUR OUTPUTS
SATVI has been extraordinarily productive in terms
of clinical trial activities, having conducted 22
Phase I–IV trials of BCG and nine novel TB vaccine
candidates, among more than 25,000 research
participants, during the last 15 years. The group’s
publication output, since 2006, stands at more
than 175 co-authored papers, of which the majority
have a SATVI first or senior author. The active
SATVI postgraduate program has also produced
10 PhD graduates and several Masters graduates
during the same period.
SATVI ANNUAL REPORT 2015 5
governancesatvi Executive Committee and senior Research team
The Executive Committee is comprised of:
Director, Associate Professor: Mark Hatherill
Deputy Director Immunology, Associate Professor: Tom Scriba
Outgoing Chief Operations Officer: Dr Zameer Brey
Incoming Chief Operations Officer: Dr Masooda Kaskar
Worcester Field Site Manager: Mrs Marwou de Kock.
From left to right: Dr Masooda Kaskar, Mrs Marwou de Kock, Associate Professor Mark Hatherill, Associate Professor Tom Scriba.
SATVI ANNUAL REPORT 20156
ExECUTIVE COMMITTEE:
assoCiatE PRofEssoR MaRk HatHERill,
DiRECtoR
Mark Hatherill is a specialist
paediatrician, with
accreditation in critical care,
and an experienced clinical
trialist who is active in the
design and implementation
of innovative trials of new
TB vaccines and preventive
therapy, through several consortia. He is a Full Member of
the Institute of Infectious Disease & Molecular Medicine
(IDM) at the University of Cape Town; a member of the SA
Department of Health TB Think Tank, Working Group on
Diagnostics, Drugs and Vaccines; and a member of the
Global TB Vaccine Partnership, Working Group on
Experimental Medicine.
Dr Hatherill is funded by competitive grants from the Bill &
Melinda Gates Foundation (BMGF), Joint Global Health
Trials scheme (UK MRC/ Wellcome Trust/DfID), SA Medical
Research Council, US National Institutes of Health, and
multiple Aeras contracts.
assoCiatE PRofEssoR toM sCRiba,
DEPuty DiRECtoR
Tom Scriba (PhD) is Deputy
Director, Immunology and
directs the Clinical
Immunology Laboratory at
SATVI. He was trained in
Biological Sciences at
Stellenbosch University and
obtained a DPhil (PhD) in
T cell Immunology at Oxford University. He returned to
South Africa in 2006 to complete a postdoctoral fellowship
in Paediatric and Clinical Immunology in Tuberculosis and
Vaccinology at the Institute of Infectious Disease and
Molecular Medicine (IDM), University of Cape Town. He is
Full Member of the IDM, member of the AERAS Biomarker
and Correlates Working Group and the Bill and Melinda
Gates Foundation (BMGF) Collaboration for TB Vaccine
Discovery. He is funded by competitive grants from the
BMGF, the National Research Foundation, SA Medical
Research Council, US National Institutes of Health and the
European Union.
DR ZaMEER bREy,
CHiEf oPERatioNs offiCER (outGoiNG)
Zameer Brey, the outgoing
Chief Operations Officer,
departed from SATVI during
August 2015 for the Bill and
Melinda Gates Foundation.
DR MasooDa kaskaR,
CHiEf oPERatioNs offiCER (iNCoMiNG)
Masooda Kaskar joined
SATVI in January 2016. She
has held several senior
leadership positions within
the Pharmaceutical Industry.
At Novartis she was instru-
mental in developing and
implementing Transformational
Growth Plans that resulted in establishing Novartis’s
Leadership position within the industry. Her experience
spans Strategy, Operations, Marketing as well as
Managed Health Care. As Head of the Respiratory Division
she was instrumental in driving improvements in the area
of Cystic Fibrosis management as well as changing the
landscape of Severe Asthma by launching the first anti-IgE
therapy for the treatment of Severe Allergic Asthma in
South Africa. Masooda holds an MBCHB degree from the
University of Cape Town, as well as a MBA from UCT
Graduate School of Business.
MaRwou DE koCk,
fiElD sitE MaNaGER
Marwou de Kock graduated
from the Cape Peninsula
University of Technology with
a Degree in Biomedical
Science. She subsequently
completed a Degree in
Laboratory Management and
is currently writing a Masters
Dissertation in Clinical
Research Administration. She has been working at SATVI
since 2002 and has an intricate knowledge of the site, the
people and procedures in the laboratory, as well as clinical
operations. She started in the SATVI Field Site laboratory
and developed it into a world class facility that received
SANAS Accreditation in 2010. She is currently responsible
for managing the SATVI Field Site, overseeing and
managing service delivery for all operations, as well as
coordinating and implementing multiple research projects
at the Field Site.
SATVI ANNUAL REPORT 2015 7
DR MiCHElE taMERis,
PRiNCiPal iNvEstiGatoR
Michele Tameris graduated from the
University of Cape Town with
MBChB in 1980. Thereafter she
worked for many years in the public
health sector in Cape Town and in
Worcester. In 2003 she joined SATVI
as a clinical researcher and since
2005 has been Sub-Investigator on
16 novel TB vaccine trials and Principal Investigator on 5.
These trials have been of 9 novel TB vaccines and have
included first in man trials, phase 1, 2a and 2b trials
including the first phase 2b infant efficacy trial of a new TB
vaccine. She has been awarded two Wellcome Trust
International Engagement awards (2012 and 2014) for
projects using drama to improve community
understanding of TB clinical research.
DR HENNiE GElDENHuys,
PRiNCiPal iNvEstiGatoR
After working in private general
practice for 10 years Hennie
Geldenhuys joined SATVI full-time
in 2007. He is actively involved in
the design, conduct, and analysis
of vaccine clinical trials and other
research studies in tuberculosis. He
has fulfilled the role of Investigator
and Principal Investigator on a number of clinical trials,
and has published a number of scientific papers. Hennie is
based at SATVI’s field site in the town of Worcester. His
research interests include alternative vaccine
administration methods, clinical trials with adolescents,
quality management in clinical trials, and the science of
translating research protocols into field practice.
DR JustiN sHENJE,
PRiNCiPal iNvEstiGatoR
Justin Shenje is a clinical researcher
who has worked in various countries
across Southern Africa, including
Zimbabwe, Swaziland and South
Africa. A common theme across this
region is a high burden of tuberculosis
(TB) and HIV, which has fostered his
keen interest in tuberculosis and HIV
research. Currently Justin Shenje is the principal
investigator for our first AIDS Clinical Trials Group (ACTG)
study, A5300. This is an observational study aimed at
describing household contacts of Multi-Drug Resistant
(MDR) TB cases. He is also a clinical investigator on
several TB vaccine studies and has experience in TB
therapeutic studies and HIV prevention research.
SENIOR CLINICAL RESEARCH TEAM:
SATVI ANNUAL REPORT 20158
DR aNGEliQuE luabEya,
PRiNCiPal iNvEstiGatoR
Angelique Kany Kany
Luabeya graduated as a
Medical doctor in 1996 from
the University of Kinshasa
(DR Congo) and holds a
Masters degree in
Epidemiology from the
London School of Tropical
Medicine (LSHTM). She
joined SATVI in 2009 as a
clinical investigator from the
Africa Centre for Health and
Populations Studies at University of Kwa Zulu Natal and
has been involved as Principal Investigator in the
implementation and conduct of clinical trials of new
TB vaccines (AERAS C035-456, IDRI-TBVPx-203, and
VPM1002-ZA-2.13TB) in healthy adults, TB patients and
newborns. She has produced a number of scientific
publications and has a particular research interest in the
design and conduct of TB diagnostic studies (tuberculosis
case finding by oral swab PCR), clinical immunology
studies and health systems operational research in the
area of TB prevention in young children.
DR Elisa NEMEs,
sENioR REsEaRCH offiCER
Elisa completed her PhD in
HIV-specific T cell
immunology in Italy and
France. She then worked
on paediatric immune
responses to HIV and TB in
Cameroon. She joined
SATVI in 2011, where she
has been involved in basic
immunology studies,
clinical trials of new TB vaccines and studies of host
correlates of risk of TB disease in BCG-vaccinated infants
and of BCG/TB immune reconstitution inflammatory
syndrome in HIV+ children.
DR aDaM PENN-NiCHolsoN,
REsEaRCH offiCER
After receiving his PhD in the
USA, Adam worked in
industry on the development
and manufacture of vaccines.
He joined SATVI in 2011.
Adam’s main focus is on the
discovery of blood-based
biomarkers that prospectively
predict TB disease risk, and
understanding the biology
involved in progression from latent M. tuberculosis
infection to active TB disease. He also provides scientific
oversight of several clinical TB vaccine trials currently
being conducted at SATVI.
SATVI ANNUAL REPORT 2015 9
highlights2015
A RANDOMIZED, PARTIALLY-BLINDED, CLINICAL TRIAL
OF ISONIAZID AND RIFAPENTINE (3HP) THERAPY TO
PREVENT PULMONARY TUBERCULOSIS IN HIGH-RISK
INDIVIDUALS IDENTIFIED BY A TRANSCRIPTOMIC
CORRELATE OF RISK
SATVI, in partnership with the Center for Infectious
Disease Research in Seattle, has recently completed a
decade-long project to develop a biomarker test that
predicts whether a person is at risk of developing TB.
This prognostic blood test, which is based on the
human immune response, can predict whether a
person will develop TB more than 12 months in
advance.
SATVI investigators will now evaluate, in a large clinical
trial, whether targeted preventive therapy for people
with a positive biomarker test can stop them from
developing TB.
This international collaboration is led by SATVI, in
partnership with the Aurum Institute, Stellenbosch
University Immunology Research Group, Centre for the
AIDS Programme of Research in South Africa (CAPRISA),
London School of Hygiene and Tropical Medicine
(LSHTM), and Fred Hutchinson Cancer Research
Center (FHCRC).
This clinical trial, funded by the Bill & Melinda Gates
Foundation, will start in 2016 and will run for 2 years.
If this trial is successful, mass campaigns using a ‘screen
& treat’ strategy have potential for major impact on the
global epidemic, by stopping TB before it becomes
infectious and can be transmitted to others.
CORRELATE OF RISK TARGETED INTERVENTION (CORTIS) STUDY
SATVI ANNUAL REPORT 201510
STRATEGIC VISION OF SATVI
During July 2015 SATVI conducted a review of its Strategic Objectives
and identified the following Strategic Priority Areas:
1. High Impact TB Research
2. To build a cutting edge team for Research
3. To ensure Financial Sustainability
4. To build the SATVI brand
5. To limit risks
SATVI ANNUAL REPORT 2015 11
PHASE II RANDOMISED CONTROLLED TRIAL TO EVALUATE SAFETY AND
IMMUNOGENICITY OF MVA85A AND SELECTIVE DELAYED BACILLE CALMETTE-GUERIN
(BCG) VACCINATION IN INFANTS OF HIV INFECTED MOTHERS
Principal Investigator: Mark Hatherill
Sponsor: University of Cape Town
Follow-up of all 248 HIV exposed infants was completed by SATVI and the Stellenbosch
University teams (Principal Investigator: Anneke Hesseling) in this trial to test the safety
and immunogenicity of MVA85A vaccination at birth. The trial findings will be released
shortly.
A RANDOMISED, PLACEBO CONTROLLED, PARTIALLY BLINDED PHASED II STUDY TO
EVALUATE THE SAFETY, IMMUNOGENICITY AND PREVENTION OF INFECTION WITH
MYCOBACTERIUM TUBERCULOSIS OF AERAS 404 AND BCG REVACCINATION IN HEALTHY
ADOLESCENTS
Principal Investigator: Mark Hatherill
Sponsor: AERAS
Study team.
Enrolment of 990 healthy, QuantiFERON negative adolescents was completed in the first
trial to test the concept that BCG and the Aeras-404 vaccine might offer protection against
primary tuberculosis infection. Follow-up is ongoing.
EFFICACY OF GSK BIOLOGICALS’ CANDIDATE TUBERCULOSIS VACCINE, M72, AGAINST TB
DISEASE IN ADULTS LIVING IN A TB ENDEMIC REGION
Principal Investigator: Mark Hatherill
Sponsor: Glaxo Smith Kline
Study team.
Enrolment of 658 healthy, QuantiFERON positive adults was completed in this large,
multi-centre trial that will test protection against active tuberculosis disease. Follow-up is
ongoing.
ONGOING CLINICAL TRIALS
SATVI ANNUAL REPORT 201512
A PHASE II, RANDOMISED, OBSERVER-BLINDED, SINGLE CENTRE TRIAL EVALUATING THE
IMMUNOGENICITY AND SAFETY OF TWO DOSES OF AN ADJUVENATED TB SUBUNIT
VACCINE (AG85B-ESAT-6+IC31) USING 2 DIFFERENT VACCINATION SCHEDULES IN
HEALTHY ADOLESCENTS.
Principal Investigator: Hennie Geldenhuys
Funder: Statens Serum Institute (SSI)
In this trial the H1:IC31 TB vaccine candidate was tested in 240 adolescents for safety
and immunogenicity. The last participant visit was conducted in December 2013. All of
the substantial immunology endpoints (Elispot and intracellular cytokine staining by flow
cytometry) were performed by the SATVI laboratory. The clinical trial report and manuscript
are in preparation.
PHASE 1B RANDOMIZED, DOUBLE-BLIND, DOSE-FINDING CLINICAL TRIAL TO EVALUATE
THE SAFETY, REACTOGENICITY AND IMMUNOGENICITY OF MTBVAC, IN COMPARISON
WITH BCG VACCINE SSI, IN HEALTHY HIV-NEGATIVE NEWBORNS AND ADULTS LIVING IN A
TUBERCULOSIS ENDEMIC REGION
Principal Investigator: Michele Tameris
Funder: Biofabri
During 2015 we vaccinated the first adult participants in the MTBVAC study, a clinical trial
which will evaluate the safety of the novel TB vaccine MTBVAC, firstly in adults, followed by
a dose-escalation trial of the safety and immunogenicity of MTBVAC compared to BCG in
newborns.
This novel vaccine, MTBVAC, has been developed to replace BCG, currently the only
registered TB vaccine available and routinely given at birth to all newborns. The first trial
of MTBVAC in humans was conducted in 2013 in Switzerland, with very good safety and
immunogenicity results.
This clinical trial is an important step in the development of the vaccine and is sponsored
by Biofabri. MTBVAC, which will be the first vaccine to be fully developed in Spain, was
designed by Professor Carlos Martin of the University of Zaragoza.
PHASE I/II, SAFETY AND IMMUNOGENICITY STUDY OF A RECOMBINANT PROTEIN
TUBERCULOSIS VACCINE (AERAS-404) IN BCG-PRIMED INFANTS
Principal Investigator: Michele Tameris
Funders: AERAS, National Institute of Allergy and Infectious Diseases (NIAID) & Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD).
We vaccinated the first infant participant in the IMPAACT P 1113 Study with the
Aeras-404 (also known as HyVac4 or H4:IC31) candidate TB vaccine in 2015.
Study team with first participant.
Participating babies are between 9 and 14 weeks old and are receiving 3 doses of
AERAS-404 with follow up for about 15 months. The timing of the doses with respect
to routine EPI schedule and dose strength differs across 6 cohorts. Three other sites
are part of this trial – KIDCRU at Stellenbosch University, PHRU in Johannesburg and
Shandukani in Soweto.
SATVI ANNUAL REPORT 2015 13
A PHASE 1 B, RANDOMISED, DOUBLE BLIND, PLACEBO- CONTROLLED, DOSE ESCALATION
STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF THE ID 93+GLA-SE VACCINE
IN BCG VACCINATED HEALTHY ADULTS
Principal Investigator: Michele Tameris
Funder: Infectious Disease Research Institute (IDRI)
The enrolment of 66 healthy adults (QFT negative and QFT positive) into the 4 cohorts of
this Phase 1b safety, immunogenicity and dose finding trial of the adjuvanted
vaccine ID93+GLA-SE started in September 2013 and was completed in September 2014.
Follow-up was completed at the end June 2015. Data analyses are ongoing.
PHASE II DOUBLE-BLIND, RANDOMIZED, CONTROLLED STUDY TO EVALUATE SAFETY
AND IMMUNOGENICITY OF VPM1002 IN COMPARISON WITH BCG IN HIV-EXPOSED AND
HIV-UNEXPOSED, BCG-NAIVE NEWBORN INFANTS
Principal Investigator: Angelique Luabeya
Funder: Serum Institute of India
Study team with first participant.
This Phase IIa trial of the VPM1002 vaccine is the first study to investigate
VPM1002 in HIV-exposed newborn infants in a setting with a high burden of TB,
where BCG is routinely recommended at or around birth by the World Health
Organization (WHO). This is a double-blinded, randomized and controlled parallel-
group trial design to assess the safety and immunogenicity of a single dose of
VPM1002 in comparison with the current commercially available, standard BCG.
SATVI has enrolled 13 babies since August 2015 and the trial is ongoing.
A PHASE 2A, RANDOMIZED, DOUBLE-BLIND PLACEBO- CONTROLLED, CLINICAL TRIAL
TO EVALUATE SAFETY AND IMMUNOGENICITY OF THE ID93 + GLA-SE VACCINE IN HIV
UNINFECTED ADULT TB PATIENTS AFTER TREATMENT COMPLETION
Principal Investigator: Angelique Luabeya
Funder: Infectious Disease Research Institute (IDRI)
The purpose of this study is to evaluate the safety and immunogenicity of two
doses of ID93 + GLA-SE vaccine when administered to HIV uninfected adult
pulmonary TB patients, following successful completion of TB treatment with
confirmed bacteriologic cure. SATVI has enrolled 13 patients since June 2015
for the first cohort (n=20) of this trial, which is still ongoing. This trial is being
conducted in preparation for a future Phase 2b prevention of TB recurrence trial in
the same population.
Dr Angelique Luabeya with the VPM 1002 Study team.
SATVI ANNUAL REPORT 201514
STUDY OF MDR TB CASES AND THEIR HOUSEHOLD CONTACTS: OPERATIONAL FEASIBILITY
TO INFORM PHOENIX TRIAL DESIGN
Principal Investigator: Justin Shenje
Sponsor: AIDS Clinical Trial Group (ACTG)
Dr Justice Shenje with study team.
The SATVI team started their first ACTG study in November 2015, which is known as
A5300. The A5300 study seeks to evaluate the feasibility of conducting a clinical trial which
intends to determine the safety and efficacy of Bedaquiline (a new TB drug) in preventing
the transmission of TB to household contacts of MDR TB cases.
A PHASE I/II A DOUBLE BLIND, RANDOMISED, PLACEBO- CONTROLLED, DOSE-FINDING
STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF AERAS-456 IN HIV NEGATIVE
ADULTS WITH AND WITHOUT LATENT TUBERCULOSIS INFECTION
Principal Investigator: Angelique Luabeya
Funder: AERAS
This Phase IIa trial of the H56:IC31 (designated Aeras456) vaccine, which incorporates
three M. tuberculosis-specific antigens that target several stages of the complex host-
pathogen interaction, is being conducted in HIV-uninfected South African adults with
or without latent M. tuberculosis infection, in collaboration with Statens Serum Institute
(Denmark) and AERAS (USA). Participant vaccination and follow-up have been completed
and data analyses are ongoing.
SATVI ANNUAL REPORT 2015 15
TUBERCULOSIS CASE FINDING BY ORAL SWAB
Principal Investigator: Angelique Luabeya
Funder: National Institute of Health
This project will evaluate oral swab analysis (OSA) as a novel alternative to sputum
analysis for pulmonary TB diagnosis and active case finding. The hypothesis is that
oral swabs are simpler, cleaner, non-invasive, less hazardous and more uniform
alternatives to sputum. If validated, OSA could facilitate point-of-care (POC)
strategies that are not feasible for sputum testing. It could also enable TB diagnosis
in patients who cannot produce diagnostic sputum samples, including children. The
study will start recruitment in February 2016.
Tuberculosis Case Finding by Oral Swab as alternative to Sputum Analysis.
OTHER STUDIES
SATVI ANNUAL REPORT 201516
CORRELATE OF RISK TARGETED INTERVENTION STUDY – CORTIS
A RANDOMIZED, PARTIALLY-BLINDED, CLINICAL TRIAL OF ISONIAZID AND RIFAPENTINE
(3HP) THERAPY TO PREVENT PULMONARY TUBERCULOSIS IN HIGH-RISK INDIVIDUALS
IDENTIFIED BY A TRANSCRIPTOMIC CORRELATE OF RISK.
National Principal Investigator: Mark Hatherill
SATVI Principal Investigator: Michele Tameris
Sponsor: University of Cape Town
This multicenter clinical trial, to be conducted in collaboration with our partners
at Aurum, CAPRISA, Stellenbosch University, Fred Hutchinson Cancer Research
Center and the London School of Hygiene and Tropical Medicine, is funded by a
multi-million dollar grant from the Bill & Melinda Gates Foundation. The trial builds
on a decade-long effort by scientists at SATVI and the Center for Infectious Disease
Research, Seattle, to develop a Correlate of Risk for TB. We will now use this
transcriptomic signature to target persons at high risk of developing TB disease for
preventive therapy. The CORTIS trial will enroll 3,200 participants at 4 sites in South
Africa and is scheduled to start in mid-2016.
PLANNED CLINICAL TRIALS
SATVI ANNUAL REPORT 2015 17
In addition to its focus on TB vaccines, SATVI is contributing to the exciting and
growing field of clinical research into new drugs for drug sensitive and resistant TB.
In 2016 at least three new clinical trials are expected to start in collaboration with
the AIDS Clinical Trial Group (ACTG) network, of which SATVI became an accredited
clinical research site in 2015. These trials include the A5343 trial (A Trial of the
Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and
in Combination, among Participants Taking Multidrug Treatment for Drug-Resistant
Pulmonary Tuberculosis), A5349 (Rifapentine-containing treatment shortening
regimens for pulmonary tuberculosis: a randomized, open-label, controlled, phase 3
clinical trial) and the STAND trial (A Phase 3 Open-Label Partially Randomized Trial
to Evaluate the Efficacy, Safety and Tolerability of the Combination of Moxifloxacin
plus PA-824 plus Pyrazinamide after 4 and 6 months of Treatment in Adult Subjects
with Drug-Sensitive Smear-Positive Pulmonary Tuberculosis and after 6 months of
Treatment in Adult Subjects with Multi-Drug Resistant, Smear-Positive Pulmonary
Tuberculosis).
ExPANSION INTO STUDIES OF NEW DRUGS FOR DRUG SENSITIVE AND RESISTANT TB
SATVI ANNUAL REPORT 201518
DRAMA SETS THE STAGE
Principal Investigator: Michele Tameris
Funder: Welcome Trust
Supported by a Wellcome Trust International Engagement
award in 2012, SATVI facilitated a drama production to
promote awareness about TB vaccine clinical research,
titled “Carina’s Choice” with learners from Worcester
Secondary School as actors and UCT drama school
students as mentors. A very successful roadshow
to 8 local high schools reached approximately 8 000
adolescents in 2013. DVDs with English or xhosa subtitles
have been produced for distribution as well as free
download access on SATVI website.
https://www.youtube.com/watch?v=pAosgZO-O0k
Drama performed at local schools.
BEAT TB – IT’S YOUR CHOICE
Principal Investigator: Michele Tameris
Funder: Welcome Trust
A second Wellcome Trust International Engagement
grant was awarded in October 2014 for a street
theatre project, which commenced in 2015 and
will run until the end of 2016. This will build on
work in the first drama project, taking the issue
of TB research into the streets, targeting the local
adult population.
Beat TB Street Theatre Project, November 2015.
AWARENESS-RAISING
SATVI ANNUAL REPORT 2015 19
INDUCTION OF NON-CLASSICAL T CELL RESPONSES BY BCG VACCINATION
Principal Investigators: Tom Scriba and Mark Hatherill
Funder: TB Research Unit of the National Institutes of
Health
BCG is the only licensed and partially efficacious vaccine
against TB disease. One third of the global population is
estimated to be latently M. tuberculosis infected (LTBI),
and hence at risk of TB disease. These infected individuals
may benefit from vaccination. We performed a Phase I
trial of BCG revaccination to study induced immune
responses. BCG contains a wide range of antigens,
which include protein antigens presented by classical
T cells and restricted to specific human leukocyte antigen
(HLA) haplotypes. BCG also contains lipid antigens and
microbial metabolites presented by unconventional
T cells, which are not restricted by donor HLA haplotypes.
In our study, we found that BCG re-vaccination of LTBI
individuals induces a wide variety of conventional T cell
responses, as well as responses by unconventional
T cells.
In addition, BCG-reactive innate natural killer cells
persisted up to one year post-vaccination. These results
collectively suggest that BCG induces a variety of donor-
unrestricted immune responses, which may guide novel
vaccine development strategies.
PREDICTIVE GENE EXPRESSION SIGNATURES FOR INCIDENT TB IN HIV-INFECTED PERSONS
Principal Investigator: Tom Scriba
Funder: Strategic Health Innovation Partnerships of the
SA Medical Research Council
A large proportion of TB cases are co-infected with HIV
and underlying HIV infection significantly increases risk
of TB disease in individuals with latent M. tuberculosis
infection. We have successfully developed and validated
a transcriptomic correlate of risk (CoR) that can predict
progression from M. tuberculosis infection in healthy
persons to TB disease.
This project aims to determine if the transcriptomic
CoR can predict risk of incident TB in HIV-infected
persons. We are retrieving stored samples from
completed clinical trials or cohort studies of
TB in HIV-infected populations, performed in
South Africa. Gene expression signatures of
candidate transcriptomic CoR are being measured
by microfluidic qRT-PCR in progressors, who
developed microbiologically confirmed TB, or
in controls, who remained healthy. The project
is highly collaborative and involves scientists
from SATVI, CAPRISA, the Desmond Tutu HIV
Centre, Stellenbosch University and the Center for
Infectious Disease Research in Seattle, USA.
POINT-OF-CARE MEDICAL DEVICE FOR MONITORING THE FUNCTIONAL IMMUNE RESPONSE TO MYCOBACTERIA
Principal Investigator: Tom Scriba
Funder: Bill & Melinda Gates Foundation
Diagnosis of TB disease is challenging and requires
collection of a good quality sputum specimen from the
patient and detection of the M. tuberculosis bacterium.
A test that could be performed at the point of patient care
in resource-poor settings and that does not depend on
sputum would be a major advance in the fight against TB.
This project aims to test novel and standardized whole
blood assays to identify immune response signatures that
can discriminate between asymptomatic M. tuberculosis
infection and active TB disease. We are measuring many
features of the immune response, including release of
soluble immune mediators, phenotype and function of cell
types important to control M. tuberculosis as well as gene
expression. The project is a collaboration with the Pasteur
Institute in Paris, France.
IMMUNOLOGY
SATVI ANNUAL REPORT 201520
PRIMING OF CD4 T CELL RESPONSES IN ACUTE MYCOBACTERIUM TUBERCULOSIS INFECTION
Principal Investigator: Tom Scriba
Funders: South Africa Medical Research Council
(SA MRC)
An improved understanding of the events underlying
priming of T cell responses during acute M. tuberculosis
infection of humans is critical to inform vaccination
strategies aimed at initial containment of M. tuberculosis
infection.
In this project we aimed to determine the phenotypic
and activation profiles of M. tuberculosis-specific CD4
T cells during and after new acquisition of M. tuberculosis
infection in a longitudinal study of adolescents. Acute
infection was defined by Quantiferon assay conversion.
We used HLA-class II tetramers bearing ESAT-6 and CFP-
10 peptides to detect M. tuberculosis-specific CD4 T cells
and performed phenotypic analysis using multiparameter
flow cytometry.
During the early stages of human infection,
M. tuberculosis-specific CD4 T cells are highly activated
and display an effector phenotype, consistent with high
levels of bacterial replication. Following acute infection
M. tuberculosis-specific CD4 T cells transition to a central
memory phenotype and express lower levels of activation
markers. As observed previously in experimental
M. tuberculosis infection of mice, these data suggest that
established infection in humans is associated with lower
levels of antigen stimulation than acute infection, likely due
to lower bacterial replication.
CORRELATES OF RISK OF IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME IN HIV+ CHILDREN STARTING ANTIRETROVIRAL TREATMENT
Principal Investigator: Elisa Nemes
Funders: International Maternal Pediatric Adolescent AIDS
Clinical Trials Network (IMPAACT) and Miami Center for
AIDS Research
Immune Reconstitution Inflammatory Syndrome (IRIS) is
an over-exuberant host inflammatory response to pre-
existing infections or live vaccines such as BCG, which
manifests in some HIV-infected persons when damaged
immunity is restored after starting antiretroviral treatment
(ART). This project aims to identify host immune correlates
of risk of IRIS in HIV-infected children starting ART.
We are comparing mycobacteria and HIV-specific immune
responses and whole blood gene expression profiles in
children who initiated ART and who either developed
IRIS or who remained free of disease. Identification of
predictive biomarkers would facilitate IRIS diagnosis and
allow development of preventative interventions.
SATVI ANNUAL REPORT 2015 21
FULL IDM MEMBERSHIP
During September 2015 Associate Professor Tom Scriba
was appointed a Full Member of the Institute of Infectious
Disease and Molecular Medicine (IDM) in recognition of
his achievements in TB vaccinology and immunology
research.
MEIRING NAUDE MEDAL
Associate Professor Tom Scriba was presented with
the Meiring Naude Medal by the Royal Society during
September 2015. The medal is awarded to outstanding
early career scientists, who have already made a mark
in their field and who are poised to become scientific
leaders.
SCHOLARSHIP AWARDS
Dr Elisa Nemes was selected for the International Society
for the Advancement of Cytometry (ISAC) Scholars
Program, which is designed to enhance the scientific and
leadership experiences of scientific research leaders in the
field of cytometry. This is in recognition of scientific skills,
research accomplishments, leadership potential and ability
to achieve career goals.
Dr Angelique Luabeya, Principal Investigator was awarded
an European & Developing Countries Clinical Trials
Partnership -TDR Clinical Research Fellowship. She will be
based at GSK in Siena, Italy for 12 months in 2016.
MEMBERSHIP OF COMMITTEES
Marwou de Kock, Field Site Manager was elected Chair
of the Faculty of Health Sciences Clinical Research
Operations Management (CROM) Working Group.
Simba Mabwe, Worcester Laboratory Manager was
elected to the AIDS Clinical Trial Group (ACTG) Laboratory
Technologist Committee.
AWARDS, PRIZES AND HONOURS
SATVI ANNUAL REPORT 201522
research outputsDuring 2015, our publication output was 28 articles, which appeared in international peer reviewed journals. Fifteen of these had first and/or last authors from SATVI including reports of five Phase I/II trials of BCG or novel TB vaccine candidates.
PUBLICATIONS IN PEER REVIEWED JOURNALS
1. First-in-human trial of a live-attenuatedMycobacterium tuberculosis vaccine. GeldmacherC, Hatherill M. Lancet Respir Med. 2015Dec;3(12):906-7.
2. Evaluation of Xpert® MTB/RIF Assay in InducedSputum and Gastric Lavage Samples from YoungChildren with Suspected Tuberculosis from theMVA85A TB Vaccine Trial. Bunyasi EW, TamerisM, Geldenhuys H, Schmidt BM, Luabeya AK,Mulenga H, Scriba TJ, Hanekom WA, MahomedH, McShane H, Hatherill M. PLoS One. 2015 Nov10;10(11):e0141623.
3. The TB-specific CD4(+) T cell immune repertoirein both cynomolgus and rhesus macaques largelyoverlap with humans. Mothé BR, LindestamArlehamn CS, Dow C, Dillon MB, Wiseman RW,Bohn P, Karl J, Golden NA, Gilpin T, Foreman TW,Rodgers MA, Mehra S, Scriba TJ, Flynn JL, KaushalD, O’Connor DH, Sette A. Tuberculosis (Edinb). 2015Dec;95(6):722-35.
4. T Cell Responses against Mycobacterial Lipids andProteins Are Poorly Correlated in South AfricanAdolescents. Seshadri C, Lin L, Scriba TJ, PetersonG, Freidrich D, Frahm N, DeRosa SC, Moody DB,
Prandi J, Gilleron M, Mahomed H, Jiang W, Finak G, Hanekom WA, Gottardo R, McElrath MJ, Hawn TR. J Immunol. 2015 Nov 15;195 (10):4595-603.
5. A side-by-side comparison of T cell reactivity tofifty-nine Mycobacterium tuberculosis antigensin diverse populations from five continents.Carpenter C, Sidney J, Kolla R, Nayak K, TomiyamaH, Tomiyama C, Padilla OA, Rozot V, Ahamed SF,Ponte C, Rolla V, Antas PR, Chandele A, Kenneth J,Laxmi S, Makgotlho E, Vanini V, Ippolito G, KazanovaAS, Panteleev AV, Hanekom W, Mayanja-Kizza H,Lewinsohn D, Saito M, McElrath MJ, Boom WH,Goletti D, Gilman R, Lyadova IV, Scriba TJ, KallasEG, Murali-Krishna K, Sette A, Lindestam ArlehamnCS. Tuberculosis (Edinb). 2015 Dec;95(6):713-21.
6. Risk of Disease After Isoniazid Preventive Therapyfor Mycobacterium tuberculosis Exposure inYoung HIV-uninfected Children. Luabeya KK,Tameris MD, Geldenhuys HD, Mulenga H, VanSchalkwyk A, Hughes EJ, Toefey A, Scriba TJ,Hussey G, Mahomed H, McShane H, Landry B,Hanekom WA, Hatherill M. Pediatr Infect Dis J. 2015Nov;34(11):1218-22.
7. The Role of Clinical Symptoms in theDiagnosis of Intrathoracic Tuberculosis in YoungChildren. Mulenga H, Tameris MD, Luabeya KK,Geldenhuys H, Scriba TJ, Hussey GD, Mahomed H,Landry BS, Hanekom WA, McShane H, Hatherill M.Pediatr Infect Dis J. 2015 Nov;34(11):1157-62.
8. First-in-human trial of the post-exposuretuberculosis vaccine H56:IC31 in Mycobacteriumtuberculosis infected and non-infected healthyadults. Luabeya AK, Kagina BM, Tameris MD,
Geldenhuys H, Hoff ST, Shi Z, Kromann I, Hatherill M, Mahomed H, Hanekom WA, Andersen P, Scriba TJ and the H56-032 Trial Study Group. Vaccine. 2015 Aug 7;33(33):4130-40.
9. Safety and immunogenicity of candidate vaccineM72/AS01E in adolescents in a TB endemicsetting. Penn-Nicholson A, Geldenhuys H, Burny W,van der Most R, Day CL, Jongert E, Moris P, HatherillM, Ofori-Anyinam O, Hanekom W and the VaccineStudy Team. Vaccine. 2015 Jul 31;33(32):4025-34.
10. The tuberculosis vaccine H4:IC31 is safe andinduces a persistent polyfunctional CD4 T cellresponse in South African adults: A randomizedcontrolled trial. Geldenhuys H, Mearns H, Miles DJ,Tameris M, Hokey D, Shi Z, Bennett S, AndersenP, Kromann I, Hoff ST, Hanekom WA, Mahomed H,Hatherill M, Scriba TJ and the H4:IC31 Trial StudyGroup. Vaccine. 2015 Jul 9;33(30):3592-9.
11. Mycobacteria-Specific Cytokine Responses DetectTuberculosis Infection and Distinguish Latent fromActive Tuberculosis. Tebruegge M, Dutta B, DonathS, Ritz N, Forbes B, Camacho-Badilla K, Clifford V,Zufferey C, Robins-Browne R, Hanekom W, GrahamSM, Connell T, Curtis N. Am J Respir Crit Care Med.2015 Aug 15;192(4):485-99.
12. COMPASS identifies T-cell subsets correlated withclinical outcomes. Lin L, Finak G, Ushey K, SeshadriC, Hawn TR, Frahm N, Scriba TJ, Mahomed H,Hanekom W, Bart PA, Pantaleo G, Tomaras GD,Rerks-Ngarm S, Kaewkungwal J, Nitayaphan S,Pitisuttithum P, Michael NL, Kim JH, Robb ML,O’Connell RJ, Karasavvas N, Gilbert P, C De Rosa
SATVI ANNUAL REPORT 2015 23
S, McElrath MJ, Gottardo R. Nat Biotechnol. 2015 Jun;33(6):610-6.
13. A population response analysis approach to assignclass II HLA-epitope restrictions. Paul S, DillonMB, Lindestam Arlehamn CS, Huang H, Davis MM,McKinney DM, Scriba TJ, Sidney J, Peters B, SetteA. J Immunol. 2015 Jun 15;194(12):6164-76.
14. A double-blind, randomised, placebo-controlled,dose-finding trial of the novel tuberculosis vaccineAERAS-402, an adenovirus-vectored fusionprotein, in healthy, BCG-vaccinated infants. TamerisM, Hokey DA, Nduba V, Sacarlal J, Laher F, KiringaG, Gondo K, Lazarus EM, Gray GE, NachmanS, Mahomed H, Downing K, Abel B, Scriba TJ,McClain JB, Pau MG, Hendriks J, DheenadhayalanV, Ishmukhamedov S, Luabeya AK, GeldenhuysH, Shepherd B, Blatner G, Cardenas V, Walker R,Hanekom WA, Sadoff J, Douoguih M, Barker L,Hatherill M. Vaccine. 2015 Jun 9;33(25):2944-54.
15. Development and validation of a broad scheme forprediction of HLA class II restricted T cell epitopes.Paul S, Lindestam Arlehamn CS, Scriba TJ, DillonMB, Oseroff C, Hinz D, McKinney DM, Carrasco ProS, Sidney J, Peters B, Sette A. J Immunol Methods.2015 Jul;422:28-34.
16. A randomized clinical trial in adults and newbornsin South Africa to compare the safety andimmunogenicity of bacille Calmette-Guérin (BCG)vaccine administration via a disposable-syringe jetinjector to conventional technique with needle andsyringe. Geldenhuys HD, Mearns H, Foster J, SaxonE, Kagina B, Saganic L, Jarrahian C, Tameris MD,Dintwe OB, Van Rooyen M, Luabeya KK, Hussey G,Scriba TJ, Hatherill M, Zehrung D. Vaccine. 2015 Sep8;33(37):4719-26.
17. Mycobacterium tuberculosis-specific CD4 T cellsare the principal source of IFN-y in QuantiFERONassays in healthy persons. Penn-Nicholson A,
Nemes E, Hanekom WA, Hatherill M, Scriba TJ. Tuberculosis (Edinb). 2015 May;95(3):350-1.
18. Innovative clinical trial designs to rationalizeTB vaccine development. Ellis RD, Hatherill M,Tait D, Snowden M, Churchyard G, Hanekom W,Evans T, Ginsberg AM. Tuberculosis (Edinb). 2015May;95(3):352-7.
19. Detection of Mycobacterium tuberculosis DNA onthe oral mucosa of tuberculosis patients. Wood RC,Luabeya AK, Weigel KM, Wilbur AK, Jones-EngelL, Hatherill M, Cangelosi GA. Sci Rep. 2015 Mar2;5:8668.
20. A Review and Proposed Approach to theNeutrophilic Dermatoses of Childhood. WebbK, Hlela C, Jordaan HF, Suliman S, Scriba T,Lipsker D, Scott C. Pediatr Dermatol. 2015 Jul-Aug;32(4):437-46.
21. T cells and adaptive immunity to Mycobacteriumtuberculosis in humans. Jasenosky LD, Scriba TJ,Hanekom WA, Goldfeld AE. Immunol Rev. 2015Mar;264(1):74-87.
22. The dynamics of QuantiFERON-TB gold in-tubeconversion and reversion in a cohort of SouthAfrican adolescents. Andrews JR, Hatherill M,Mahomed H, Hanekom WA, Campo M, Hawn TR,Scriba TJ. Am J Respir Crit Care Med. 2015 Mar1;191(5):584-91.
23. The impact of HIV exposure and maternalMycobacterium tuberculosis infection on infantimmune responses to bacille Calmette-Guérinvaccination. Jones CE, Hesseling AC, Tena-CokiNG, Scriba TJ, Chegou NN, Kidd M, Wilkinson RJ,Kampmann B. AIDS. 2015 Jan 14;29(2):155-65.
24. Qualification of a whole blood intracellular cytokinestaining assay to measure mycobacteria-specificCD4 and CD8 T cell immunity by flow cytometry.Kagina BM, Mansoor N, Kpamegan EP, Penn-
Nicholson A, Nemes E, Smit E, Gelderbloem S, Soares AP, Abel B, Keyser A, Sidibana M, Hughes JE, Kaplan G, Hussey GD, Hanekom WA, Scriba TJ. J Immunol Methods. 2015 Feb;417:22-33.
25. Differential leukocyte counting and immunophenotyping in cryopreserved ex vivo whole blood. Nemes E, Kagina BM, Smit E, Africa H, Steyn M, Hanekom WA, Scriba TJ. Cytometry A. 2015 Feb;87(2):157-65.
26. Combined use of Mycobacterium tuberculosis-specific CD4 and CD8 T-cell responses is a powerful diagnostic tool of active tuberculosis. Rozot V, Patrizia A, Vigano S, Mazza-Stalder J, Idrizi E, Day CL, Perreau M, Lazor-Blanchet C, Ohmiti K, Goletti D, Bart PA, Hanekom W, Scriba TJ, NicodL, Pantaleo G, Harari A. Clin Infect Dis. 2015 Feb1;60(3):432-7.
27. Relationship between female genital tract infections, mucosal interleukin-17 production and local T helper type 17 cells. Masson L, Salkinder AL, Olivier AJ, McKinnon LR, Gamieldien H, Mlisana K, Scriba TJ, Lewis DA, Little F, Jaspan HB, Ronacher K, Denny L, Abdool Karim SS, Passmore JA. Immunology. 2015 Dec;146(4):557-67.
28. Antiviral Innate Immune Activation in HIV-Infected Adults Negatively Affects H1/IC31-Induced Vaccine-Specific Memory CD4+ T cells. Lenz N, Schindler T, Kagina BM, Zhang JD, Lukindo T, Mpina M, Bang P, Kromann I, Hoff ST, Andersen P, Reither K, Churchyard GJ, Certa U, Daubenberger CA. Clin Vaccine Immunol. 2015 Jul;22(7):688-96.
SATVI ANNUAL REPORT 201524
postgraduate students and postdoctoral fellows
Dr Munyaradzi Musvosvi obtained his PhD, December 2015.SATVI students participated in the 46th Union World Conference on Lung Health from 2–6 December 2015.
The SATVI Postdoctoral research team was involved with a series of workshops aimed at school pupils, teaching them the sciences of TB and TB vaccine development, in conjunction with the Clinical Infectious Diseases Research Initiative (CIDRI).
Dr Adam Penn-Nicholson presented a workshop at the Shanghai International School about TB and the work that SATVI does – May 2015.
SATVI attracts students from
mainly Africa and Europe, who
want to study tuberculosis within
a clinical research environment.
In 2015, SATVI took in one BSc
Honours, four MPhil, two MSc
and two PhD students, as well
as 8 postdoctoral research
fellows.
SATVI ANNUAL REPORT 2015 25
satvistaff
SATVI ANNUAL REPORT 201526
During 2015 we organised the following initiatives/
activities to either develop staff or involve staff in the
local community:
• BrightSparksInnovationProgram
• StaffWellnessProgram
• Women’sDay
• CasualDay
• CANSATea
• CommemoratingMandelaDay
• SecretaryandBossesDay
• QuarterlyStaffMeetingsandTeambuildingto
promote communication, teambuilding, cooperation
and cohesion.
• TrainingofHealthandSafetyCommittees
• ParticipationintheUnionWorldConferenceon
Lung Health
Work session during quarterly staff meeting, May 2015. Sister Rachel Oelofse knitted a blanket which was raffled to raise funds for Mandela Day. The proceeds were used to support local causes SATVI had identified.
Staff who attended the Union World Conference on Lung Health, 2–6 December 2015.
Staff Wellness Day, November 2015.
SATVI staff who celebrated Nurses Day on 12 May 2015.
SATVI ANNUAL REPORT 2015 27
During the year under review we have sustained our involvement in the
Cape Winelands community through several initiatives, including:
MANDELA DAY
For Mandela Day, we supported the establishment of a Victim Support
Centre at the Maria Pieterse Clinic, the donation of equipment to the
Cornerstone Therapeutic Centre (Drug Rehabilitation Centre), Brave
Hearts Care Centre for children and Zwelethemba Book Club. Staff also
donated goods and toys from their own coffers which we donated to the
Brave Heart Centre in De Doorns.
Handing over equipment to Victim Support Centre, Maria Pieterse Clinic, Worcester.
community involvement
SATVI ANNUAL REPORT 201528
For World TB Day we partnered with AERAS to bring the
Kick TB Progam to schools in the Worcester area and held
a Kick TB Wellness Program on Saturday 28 March 2015
in Zwelethemba.
SCHOOL TB AWARENESS RAISING PROGRAM – PARTNERSHIP WITH AERAS
On World TB Day, which falls on 24 March annually,
we rolled the Kick TB Program out at four (4)
schools in the Worcester area, reaching 5 000
learners with health messages about the signs and
symptoms of TB and how to prevent it. The schools
that participated in the program were Roodewal
Primary, Alfred Stamper, Avian Park Primary and
Vusisiwe Secondary School.
Kick TB Program at Vusisiwe Secondary School.
Kick TB Program at Roodewal Primary.
WORLD TB WELLNESS DAY
This year SATVI marked World TB Day with a number
of initiatives culminating in a World TB Wellness Day
which took place at the Zwelethemba Sport Stadium on
Saturday 28 March 2015.
The Kick TB Soccer tournament was launched on
Saturday 7 March 2015 in partnership with the South
African Football Association (SAFA), which saw soccer
clubs in the under 13, 15 and 17 categories playing
against each other with six (6) teams emerging to play
against each other for the Kick TB Cup on Saturday
28 March 2015. The day’s proceedings included a 3.5 km
Fun Run, Kick TB Soccer Tournament, health screening by
the Department of Health, Indigenous Games, a keynote
speech by Professor Marian Jacobs (UCT retired Dean
of Health Faculty). Local artists provided entertainment.
SATVI staff volunteered to provide essential services
like catering, health and safety, marshalling and event
management.
3.5 km Fun Run.
Soccer Tournament.
WORLD TB DAY
SATVI ANNUAL REPORT 2015 29
SATVI Laboratory Manager Simba Mabwe and Dr Katrina Downing participating in Fun Run.
Retired Dean of Health Sciences Faculty, Professor Marian Jacobs addressing audience.
Mass TB Awareness Programme.
TB AWARENESS RAISING AT WORCESTER MALL
On Friday 27 March SATVI coordinated a TB Awareness
Program at the local shopping mall which included a
screening facility by the Department of Health, information
exhibitions by organisations like the Boland Hospice,
SATVI and a local sport organisation who conducted
recruitment for a local road race.
PARTICIPATING ORGANISATIONS:The organisations who made the program a
success were:-
• CapeWinelandsDistrictMunicipality,for
providing funding.
• DepartmentofHealth,whoprovidedhealth
screening and program support.
• GovernmentCommunications(GCIS),
which assisted with marketing and
communications.
• BreedeValleyMunicipalityforprovidingthe
venue.
• SouthAfricanFootballAssociation
Winelands (SAFA), who managed the soccer
tournament.
• Privatesectordonors,whocontributed
financially and in kind to make the day a
success.
Through an information stall we distributed information about TB and the work that SATVI does.
Soccer teams played against each other for the 2015 Kick TB Cup.
SATVI ANNUAL REPORT 201530
community advisory boardACTG
The Boland Research CAB, which is a member of
the AIDS Clinical Trials Group (ACTG) network, an
international clinical trial organisation, participated in
the Annual ACTG Network meeting in the USA held
during June 2015. The Chairperson, Belinda Ameterra,
was elected as a member of the Site Management and
Clinical Care Committee (SMCCC), a sub-committee
of the Global CAB of ACTG.
Rural Research Days, Ukwanda Rural Health, University of Stellenbosch, Worcester.
YOUTH CAB
During 2015 the CAB has been further expanded to include
a youth CAB and the new members received training in
Good Clinical Practice.
ExTERNAL RELATIONSHIPS
During March 2015 the CAB participated in the proceedings
of the Rural Health Days organised by Ukwanda Rural
Health School (University of Stelllenbosch) presenting a
paper titled “Boland Research Community Advisory Board”.
The Boland Research CAB also participated in the founding
proceedings of the UCT Core CAB, a forum created by UCT
comprising of CAB representatives from various CAB's
within the UCT clinical research community.
The CAB also participated in a Youth Training program
hosted by Post-Doctoral students from the Clinical
Infectious Diseases Research Initiative (CIDRI) and SATVI.
A video which is a product of this project, was also
screened to the broader CAB.Dr Hennie Geldenhuys addressing CAB members.
Members of Youth CAB during GCP training.
During 2015 we supported the CAB through
structured capacity development, logistical and
administrative support.
The Community Advisory Board (CAB) serves as an
important consultation channel around the development
of consenting processes, understanding the aims of
clinical research studies conducted, the identification of
and dealing with ethical issues, and generally improving
the relationship between the community, government,
researchers and health care providers.
SATVI ANNUAL REPORT 2015 31
funders
SATVI ANNUAL REPORT 201532
collaborators
TUBERCULOSISFOUNDATION
To eliminate TB
!!®
DEPARTMENT OF
ENVIRONMENTAL & OCCUPATIONAL HEALTH SCIENCES
UNIVERSITY of WASHINGTONSchool of Public Health
South African Tuberculosis Vaccine Initiative (SATVI)
Institute of Infectious Disease and Molecular Medicine (IDM),
Health Sciences Faculty, University of Cape Town
Werner & Beit Building, Anzio Road, Observatory, 7925
(T) 021 – 406 6014/13/12 www.satvi.uct.ac.za
Visit us on Facebook at: www.facebook/satviuct