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Liya Wassie (PhD) April 18-19, 2011 East Africa Consortium for Clinical Research, Moshi, Tanzania.

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Presentation on theme: "Liya Wassie (PhD) April 18-19, 2011 East Africa Consortium for Clinical Research, Moshi, Tanzania."— Presentation transcript:

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

2  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

3  Established in 1970 by ◦ University of Bergen, the Norwegian and Swedish Save the Children organizations and the Ethiopian Ministry of Health

4  Named after Gerhard Henrik Armauer Hansen ◦ First described the leprosy bacillus (Mycobacterium leprae)

5  Tripartite agreement in 1995 ◦ Between Norway, Sweden and Ethiopia as an autonomous research institute, run by a Board

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

7  Celebrates its 40 th Anniversary ◦ In March 2010

8  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

9  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  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  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 Disease portfolioBasicApplied Capacity building Tuberculosis (50%) Leprosy (10%) Leishmaniasis (10%) Meningitis (10%) HIV/STI, other (20%)

13  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  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  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  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  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  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  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  Established at AHRI as a unit in Dec ◦ 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  Each research project should constitute a capacity building component ◦ Contribution to postgraduate training ◦ Build a critical mass of researchers in Ethiopia

22  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, …

23  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 AAERC PABIN

24  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 5 th TRAC conference (October 21-23, 2009), Jimma University with TBCAP, WHO, MoH

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

26  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)

27 541 publications since 1970

28  Dissemination of research output (for local community and stakeholders) A9 study, Chencha community (9 March 2007) Butajira trial, Butajira Leishmania outbreak, Silti

29  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 Qualifications of research staff over the years

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