Armauer Hansen Research Institute (AHRI, Ethiopia)

Liya Wassie (PhD)April 18-19, 2011

East Africa Consortium for Clinical Research, Moshi, Tanzania

History Strategic plan Capacity at AHRI

◦ Conducting basic and applied biomedical research ◦ Conducting clinical trial activities ◦ Data management unit◦ Capacity building activities◦ Services and laboratory facilities for research ◦ Research outputs: Publications, info dissemination to the

community/study participants◦ Regular activities/events ◦ Staff profile

Funding source

Outline

Established in 1970 by◦ University of Bergen,

the Norwegian and Swedish Save the Children organizations and the Ethiopian Ministry of Health

History

Named after Gerhard Henrik Armauer Hansen◦ First described the

leprosy bacillus (Mycobacterium leprae)

History (…cont’d)

Tripartite agreement in 1995◦ Between Norway,

Sweden and Ethiopia as an autonomous research institute, run by a Board

History (…cont’d)

Since 2004, it is a government research institute (ALERT, Ethiopian MoH)

History (…cont’d)

Celebrates its 40th Anniversary◦ In March 2010

History (…cont’d)

Vision◦ To be a leader in generating scientific evidence for

infectious diseases prevention and control

Mission◦ AHRI is a health research and training institution

dedicated to generating and delivering scientific evidence for decision making in infectious disease prevention and control

Strategic plan

Broad strategic objectives◦ Develop and evaluate new and improved methods

for the prevention, Rxn and control of important infectious diseases in Ethiopia

◦ Conduct basic biomedical and applied research, for better understanding of mycobacterial and other relevant infectious diseases

◦ Foster partnership with disease prevention, Rxn and control and health sector development program

◦ Build capacity for quality health research in Ethiopia and the Eastern African Region

Strategic plan (…cont’d)

Receives guidance and recommendation from SAB (Scientific Advisory Board)

◦ Composition: Academic and scientific bodies from institutions abroad and locally University of Bergen, Norway Karoliniska Institute, Sweden Stockholm University, Sweden Institute of Endemic Diseases, Sudan University of Calgary, Canada London School of Hygiene and Tropical Medicine, UK Addis Ababa University, Ethiopia

◦ Conducts annual meeting with SAB Evaluates activities performed/research outputs in the Institute

Strategic plan (…cont’d)

Conducting basic & applied biomedical research

Conducting clinical trial activities Data management unit Capacity building activities Services and laboratory facilities for research Research outputs

◦ Publications and information dissemination Regular activities/events Staff profile

Capacity at AHRI

Conducting basic and applied biomedical research

Disease portfolio BasicApplie

d

Capacity

building

Tuberculosis (50%)

Leprosy (10%)

Leishmaniasis (10%)

Meningitis (10%)

HIV/STI, other (20%)

TB (Human, Bovine)

◦ Immunology studies: Identification of biomarkers (in vitro/ex vivo correlates for

use in dxn, vaccine, drugs and risk factor analysis (nutrition, worm infections,…)

◦ Molecular biology studies: Molecular characterization of bacterial isolates (MTB, M.

bovis) to study drug resistance or susceptibility patterns, genetic studies (on bovine)

◦ Epidemiology studies: Studies on transmission pattern (b/n human and cattle)

and further typing of bacterial isolates

Biomedical research (…cont’d)

Leprosy

◦Immunology studies: Biomarker identifications for use in early

detection of M. leprae infections and epidemiological studies

◦Operational studies: Assessing performance of general health

workers in leprosy control activities at public health facilities

Biomedical research (…cont’d)

Leishmaniasis

◦ Molecular characterization of leishmania isolates Prevalence/epidemiological studies and risk factor

assessment

◦ Immunological studies Identification of underlying risk factors for specific

leishmania infections Biomarker studies: host IR to specific Ags

◦ GPS-assisted mapping of leishmania isolates For possible identification of hot spot areas for early

prediction of epidemic situations

Biomedical research (…cont’d)

Others:◦Meningitis:

Carriage rate studies, serology vs. bactericidal assays

◦Malaria: Studies on drug response patterns

◦HIV/STI: Studies of immune response vs. ART Incidence studies with/out co-infection with STI Epidemiology studies: viral typing with/out co-

infections

Biomedical research (…cont’d)

Initiated in 2001, but well established in 2007

Goals while initiating the activities: ◦ To conduct GCP standard clinical trials ◦ To upgrade/strengthen AHRI’s data management unit◦ To monitor and follow all trials conducted at AHRI for

adherence to the principles of GCP ◦ To update all AHRI research staff with newly developing

GCP ideas and practices◦ To identify research topics on issues related to GCP and

develop protocols◦ To build capacity in the area of clinical trial activities

Clinical trial activities

4FDC trial (initiated in 2001), through WHO/TDR capacity building grant ◦ Led to establishment of

data management unit development of clinical trial sites upgrading laboratory capacity improved quality at AHRI/ALERT with more interest and plan

in developing GCP trial capacity◦ A two-arm single-blinded, randomized comparison of four

fixed-dose drug combination (4FDCs) (intervention group) Vs. standard treatment with separate TB drugs (comparator group)

◦ Started patient recruitment in April 2007 with last volunteer last visit in March 2011

Clinical trials (…cont’d)

Meningitis vaccine trial◦ First GCP standard trial, sponsored by WHO/IVB◦ Initiated in December, 2005 and completed in December, 2007◦ Safety and immunogenicity of GSK Mencevax ACW polysaccharide

vaccine in Ethiopian children and adults◦ Phase II open label comparative study

TB subunit vaccine trial ◦ First phase I clinical trail in the Country, sponsored by SSI/EDCTP ◦ Initiated in 2007 and last participant last visit in April 2010◦ A safety and immunogenicity trial with an adjuvanted TB subunit

vaccine (Ag85B-ESAT-6 + IC31) administered in different antigen/adjuvant formulations in TST negative and TST positive volunteers at 0 and 2 months

◦ Documentation and follow-up is completed and data is ready for analysis

Clinical trials (…cont’d)

Established at AHRI as a unit in Dec. 2003◦ With data manager and establishment of

Proper data documentation & archiving system Acceptable data management procedures for conduct

of clinical trials and other research studies

◦ Activities Data filing, documentation and archiving Designing questionnaires (research), CRFs (clinical

trials) Data analyses Support and advice clinical trial activities at AHRI

Data management unit

Each research project should constitute a capacity building component

◦ Contribution to postgraduate training

◦ Build a critical mass of researchers in Ethiopia

Capacity building activities

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Participation on consortium projects (within AHRI’s disease portfolio) ◦ AHRI: as PI or study site

TB: BTB (WT); GC-6/AETBC (BMGF); TB-VAC/MUVAPRED, SERO-TB, VACSEL/VACSIS (EU, EDCTP); EACCR (EDCTP)

Leprosy: IDEAL (Heiser) Meningitis: MenAfriCar (BMGF, WT) Leishmania: (DFG, UBS)

Research partnership with local universities◦ AAU, Gondar University, Haromaya University,

Hawassa University, …

Capacity building (…cont’d)

Other initiatives at AHRI◦Ethics

AAERC Researchers, lawyers, social

workers and physicians Checks every study protocol

conducted at AHRI for ethical standards

SIDCER (strategic initiative for developing capacity in ethical review) recognition

ETBIN linked (National level) PABIN secretariat

AHRI as a host

Capacity building (…cont’d)AAERC

PABIN

Initiatives (…cont’d)

◦TB research advisory committee (TRAC)

Forum to disseminate research findings and recommendations to stakeholders and policy makers (FMoH, TLCP)

Helps for research translation into policy and practice

Provides evidence based decision making

Capacity building (…cont’d)

5th TRAC conference (October 21-23, 2009), Jimma University with TBCAP,

WHO, MoH

Initiatives (…cont’d)◦ Hosting national and

international meetings, workshops and short trainings

Capacity building (…cont’d)40th Anniversary (March 2010)

BTB 1st Stakeholders meeting (June 11-12, 2007)

BTB, 2nd Stakeholders meeting (June 2009)

4th molecular biology summer course AHRI/Uni Calgary 2009

Histopathology unit ◦ Provides service for research and to patients

Lab capacity◦ Location: Hospital (ALERT)-based research institute

Easy access to patients (study participants)◦ Immunology lab

Flow cytometry (8 colors), ELISA, ELISpot reader, Luminex, …◦ Molecular biology lab

PCR, Real time RT-PCR, …◦ Bacteriology lab

TB lab (P3 level) and bacteriology lab (E.g. meningitis) Library

◦ Printed journals and e-facility (HINARI,WHO/TDR)

Services and laboratory facilites

Research outputs

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541 publications since 1970

Dissemination of research output (for local community and stakeholders)

Research outputs (…cont’d)

A9 study, Chencha community (9 March 2007)

Butajira trial , Butajira

Leishmania outbreak, Silti

Regular lab meetings (weekly basis)◦ Presentation and discussion on ongoing research

findings, proposals and recent published journals

Tore Godal prize◦ Recognition for research contribution on infectious

diseases

Regular activities/events

Staff profile1

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Qualifications of research staff over the years

Funding source (core funding and grant applications)

Funding (…cont’d)

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