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Armauer Hansen Research Institute (AHRI, Ethiopia)

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1 Armauer Hansen Research Institute (AHRI, Ethiopia)
Liya Wassie (PhD) April 18-19, 2011 East Africa Consortium for Clinical Research, Moshi, Tanzania

2 Outline History Strategic plan Capacity at AHRI Funding source
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

3 History Established in 1970 by
University of Bergen, the Norwegian and Swedish Save the Children organizations and the Ethiopian Ministry of Health - Established in 1970 as a biomedical research institute, next to ALERT (a dermatology hospital) Through initiatives from

4 History (…cont’d) Named after Gerhard Henrik Armauer Hansen
First described the leprosy bacillus (Mycobacterium leprae)

5 History (…cont’d) Tripartite agreement in 1995
Between Norway, Sweden and Ethiopia as an autonomous research institute, run by a Board

6 History (…cont’d) Since 2004, it is a government research institute (ALERT, Ethiopian MoH)

7 History (…cont’d) Celebrates its 40th Anniversary In March 2010

8 Strategic plan Vision Mission
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

9 Strategic plan (…cont’d)
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

10 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

11 Capacity at AHRI 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

12 Conducting basic and applied biomedical research
Disease portfolio Basic Applied Capacity building Tuberculosis (50%) Leprosy (10%) Leishmaniasis (10%) Meningitis (10%) HIV/STI, other (20%) We conduct both basic and applied biomedical research in different disease burden of the country Each research project is carried out by individual teams in the institute and should constitute a capacity building component (either in terms of equipment facility or man power).

13 Biomedical research (…cont’d)
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

14 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

15 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

16 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

17 Clinical trial activities
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

18 Clinical trials (…cont’d)
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

19 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

20 Data management unit 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

21 Capacity building activities
Each research project should constitute a capacity building component Contribution to postgraduate training Build a critical mass of researchers in Ethiopia Essential mission for AHRI Advanced equipment, expertise, network, track record, key questions Relative scarcity of biomedical science capacity in Ethiopia and increased focus on strengthening science in higher education : transfer skills

22 Capacity building (…cont’d)
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, … EACCR= East African Consortium for Clinical Research-[Site identification/sister site=Butajira; Provides infrastructure for the sister institute] Research partnership with other local universities Gondar university Addis Ababa University

23 Capacity building (…cont’d)
AAERC 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 PABIN

24 Capacity building (…cont’d)
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 5th TRAC conference (October 21-23, 2009), Jimma University with TBCAP, WHO, MoH

25 Capacity building (…cont’d)
40th Anniversary (March 2010) Initiatives (…cont’d) Hosting national and international meetings, workshops and short trainings 4th molecular biology summer course AHRI/Uni Calgary 2009 BTB 1st Stakeholders meeting (June 11-12, 2007) BTB, 2nd Stakeholders meeting (June 2009)

26 Services and laboratory facilites
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) P3 level= AFB, culture, drug susceptibility testing, biochemical tests,….

27 Research outputs 541 publications since 1970
Publications ( , N= 541, not inclusive from 2011) Researchers often get scientific supervision both from the Institute and aboard

28 Research outputs (…cont’d)
Dissemination of research output (for local community and stakeholders) Butajira trial , Butajira A9 study, Chencha community (9 March 2007) Leishmania outbreak, Silti

29 Regular activities/events
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

30 Staff profile Qualifications of research staff over the years

31 Funding source (core funding and grant applications)

32 Funding (…cont’d)

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