Transcript Armauer Hansen Research Institute (AHRI, Ethiopia)

Liya Wassie (PhD)
April 18-19, 2011
East Africa Consortium for Clinical Research, Moshi, Tanzania
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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
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Funding source
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Established in 1970
by
◦ University of Bergen,
the Norwegian and
Swedish Save the
Children
organizations and
the Ethiopian Ministry
of Health
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Named after
Gerhard Henrik
Armauer Hansen
◦ First described the
leprosy bacillus
(Mycobacterium
leprae)
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Tripartite agreement
in 1995
◦ Between Norway,
Sweden and Ethiopia
as an autonomous
research institute, run
by a Board
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Since 2004, it is a government research institute
(ALERT, Ethiopian MoH)
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Celebrates its 40th
Anniversary
◦ In March 2010
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Vision
◦ To be a leader in generating scientific evidence for
infectious diseases prevention and control
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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
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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
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Receives guidance and recommendation from SAB
(Scientific Advisory Board)
◦ Composition: Academic and scientific bodies from
institutions abroad and locally
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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
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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
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Regular activities/events
Staff profile
Disease portfolio
Tuberculosis (50%)
Leprosy (10%)
Leishmaniasis (10%)
Meningitis (10%)
HIV/STI, other (20%)
Basic
Capacity
Applied building
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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
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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
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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
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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 coinfections
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Initiated in 2001, but well established in 2007
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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
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4FDC trial (initiated in 2001), through WHO/TDR
capacity building grant
◦ Led to establishment of
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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
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Meningitis vaccine trial
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TB subunit 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
◦ 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
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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
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Data filing, documentation and archiving
Designing questionnaires (research), CRFs (clinical trials)
Data analyses
Support and advice clinical trial activities at AHRI
16
14
12
10
8
6
4
2
DVM
MSc
PhD
Total
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
1998
1997
0
1996
◦ Build a critical
mass of
researchers in
Ethiopia
18
1995
◦ Contribution to
postgraduate
training
20
1994
Each research
project should
constitute a
capacity building
component
1993
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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)
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Research partnership with local universities
◦ AAU, Gondar University, Haromaya University,
Hawassa University, …
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Other initiatives at AHRI
AAERC
◦ 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
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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
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Initiatives (…cont’d)
40th Anniversary (March 2010)
◦ 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)
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Histopathology unit
◦ Provides service for research and to patients
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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)
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Library
◦ Printed journals and e-facility (HINARI,WHO/TDR)
Y 2008
Y 2006
Y 2004
Y 2002
Y 2000
Y 1998
Y 1996
Y 1994
Y 1992
Y 1990
Y 1988
Y 1986
Y 1984
Y 1982
Y 1980
Y 1978
Y 1976
Y 1974
Y 1972
Y 1970
30
541 publications since 1970
25
20
15
10
5
0
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Dissemination of research output (for local
community and stakeholders)
Butajira trial , Butajira
A9 study, Chencha community
(9 March 2007)
Leishmania outbreak, Silti
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Regular lab meetings (weekly basis)
◦ Presentation and discussion on ongoing research
findings, proposals and recent published journals
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Tore Godal prize
◦ Recognition for research contribution on infectious
diseases
Qualifications of research staff over the years
18
MD/PhD
16
PhD
MD
DVM
MSc
BSc
14
12
10
8
6
4
2
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
1998
1997
1996
1995
1994
1993
0
YEAR 2009
NORAD
YEAR 2008
0
YEAR 2007
5
YEAR 2006
10
Sida
YEAR 2005
15
YEAR 2004
20
100%
YEAR 2003
USD
YEAR 2002
YEAR 2009
YEAR 2008
YEAR 2007
YEAR 2006
YEAR 2005
YEAR 2004
YEAR 2003
YEAR 2002
Funds received x 105 USD
25
Other
80%
60%
40%
20%
0%