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)
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 (…cont’d)
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