Transcript EDCTP Activities - Belgian Federal Science Policy Office

EDCTP: Past and present
Consensus Meeting on EDCTP-II
27-28 September 2010
Brussels
Charles S Mgone
EDCTP Executive Director
The burden of poverty related
disease caused by HIV/AIDS,
tuberculosis and malaria
• HIV/AIDS
• 33.4 million are living with AIDS
• 2.7 million new cases per year
• 2 million deaths per year (280,000 are children)
• Tuberculosis
• > 2 billion are affected (10% will sick in their life time)
• 9.4 million new cases per year
• 1.8 million deaths per year (500,000 co-infected with HIV)
• Malaria
• Between 350 to 500 million cases per year
• > 1 million deaths per year (mostly children under 5 yrs)
EDCTP and the Millennium Development
Goals
• MDG 1 – To eradicate extreme poverty and hunger
• MDG 2 – To archive universal primary education
• MDG 3 – To promote gender equality and empower
women
• MDG 4 – To reduce child mortality
• MDG 5 – To improve maternal health
• MDG 6 – To combat HIV/AIDS, malaria and other
diseases
• MDG 8 – To develop a global partnership for
development
Working in partnerships
Participating
European Member
States
Sub-Saharan African
Countries
• Coordination of national
programmes
• Partnerships
Like-minded
Organisations
European
Commission
International
Development
Partners
PDPs
Pharma/SMEs
• Capacity development
• Networking
EDCTP Governance
• General Assembly (Policy making)
• Participating European Member States
• African representatives
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Regional Economic Communities (EAC and ECCAS)
African Union – Commission of Social Affairs
WHO/AFRO Regional Ministries of Health (Ghana and Zambia)
Ministries of Finance/Science & Technology/Higher Education & Research
• Partnership Board (Scientific Advisory)
• Developing Countries Coordinating Committee
(Capacity building requirements and African voice)
• Secretariat (Programme administration)
EDCTP Scope
The EDCTP approach
Current project portfolio
Clinical trials portfolio
HIV/AIDS
25 clinical
trials
Tuberculosis
19 clinical
trials
Malaria
12 clinical
trials
• Drugs
• Vaccines
• Microbicides
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• Drugs
• Vaccines
• Diagnostics
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• Drugs
• Vaccines
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Capacity development
MSc and PhD scholarships
Ethics and Regulatory Authority support
Career Development and Senior Fellowships
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EDCTP Networks of Excellence for
conducting clinical trials
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Botswana
Burkina Faso
Cameroon
Congo
Ethiopia
Gabon
Ghana
Guinea-Bissau
Guinea-Conakry
Kenya
Malawi
Mali
Mozambique
Nigeria
Senegal
South Africa
Sudan
Tanzania
The Gambia
Uganda
Zambia
Zimbabwe
Clinical Trials - all PRD’s
Clinical Trials - HIV
Clinical Trials – Malaria
Clinical Trials – TB
Training Awards
Ethics Capacity Strengthening
Regulatory Capacity Strengthening
Networking projects
Participating countries
EDCTP-EEIG member states
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Austria
Belgium
Denmark
France
Germany
Greece
Ireland
Italy
Luxembourg
Netherlands
Norway
Portugal
Spain
• Sweden
• Switzerland
• United Kingdom
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Sub-Saharan African countries
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Benin
• Malawi
Botswana
• Mali
Burkina Faso
• Mozambique
Cameroon
• Namibia
Congo
• Nigeria
Cote d’Ivoire
• Rwanda
Democratic Republic of Congo • Senegal
Ethiopia
• South Africa
Gabon
• Sudan
Ghana
• Tanzania
Guinea
• The Gambia
Guinea-Bissau
• Uganda
Kenya
• Zambia
Liberia
• Zimbabwe
Madagascar
TB drugs, vaccines and diagnostics R&D
• Current tuberculosis treatment regimens are very old
require long duration of many pills leading to poor
adherence and default resulting in relapses and drug
resistance (MDR, XDR, TDR)
• Immunisation with BCG is old, not fully effective and
in presence of HIV causes significant adverse events
• Diagnosis of tuberculosis is difficult, complex and
mostly unavailable at the point of care, especially in
poor endemic countries
Cohort studies and capacity
strengthening in preparation for TB
vaccines clinical trials in Kenya
Prospective epidemiological studies of TB in
neonates and adolescents in Karemo Division, Siaya
District, Western Kenya in preparation for future
vaccine trials – KEMRI/CDC, Kisumu, Kenya
KEMRI/CDC , University of Cape Town, SATVI, KNCV
Tuberculosis Foundation, VSCR, Fondazione Centro San
Raffaele del Monte Tabor (Italy), AREAS, EDCTP
Capacity Building Physical
Infrastructure
Clinical Research Centre
Siaya
Facility upgrades through
study preparations
• Construction of a clinical
research annex at the Siaya
District Hospital (research
site) including a TB
procedure room for gastric
lavage/sputum induction.
• Joint development of a
clinical research building
• Opening and launch – August
2010
Mobile Field Site (MFS)
Receptionist
Interviews and vitals
Mantoux
Sputum and Treatment
Data Centre
CO reading X-ray
Chest X-ray
Mobile x-ray truck
ACS- Overview
-Pre-Enrolment Screening
-Alerts
Not suspect/No Common Ailment
Receptionist/Dispatcher
Nursing Station 1
-Receives the participant
-Logs participant into system
-Activates movement
-Appends Bar codes on consent forms
-Logs out participant once through
Nursing Station 2
-Takes Demographic data
-Takes Clinical history, contact history
-updates movement to nurse 2
-Administers TST
-Takes vital measurements
TB Suspect
Common Ailment
Server
(Wireless
LAN)
Common Ailment
X-Ray Taken
X-Ray Station
Clinical Officer
-Takes X-ray, Completes X-ray Screen
TB Suspect
Terra byte external drive
backups
Back up in Kisian
-Reads X-ray into CRRS
-Takes clinical Notes
-Sample Received in Kisian
Lab
-Keyed into Lab Module
Reception screen
EDCTP Stakeholders’ meeting on TB
Vaccines, April 2007, The Hague
Partners Present:
AERAS Global TB Vaccine Foundation (AERAS)
Bill & Melinda Gates Foundation (BMGF)
GlaxoSmithKline Biologicals (GSK)
KNCV Tuberculosis Foundation (KNCV)
TBVAC
Vakzine Projekt Management GmbH
World Health Organisation
South African Tuberculosis vaccines Initiative (SATVI)
Medical Research Council, The Gambia
Recommendations:
• Open call for phase II clinical trials of products already in the pipeline
• Repeat call a year later for small proof-of-principle clinical trials
• Support for capacity building and networking
EDCTP funded TB vaccines clinical trials
• Ag85B-ESAT-6 (H1) + IC31 subunit vaccine (SSI)
• Phase I safety and immunogenicity in healthy adults (completed)
• Phase II safety and immunogenicity in TST positive healthy
adolescents (ongoing)
• Phase II safety and immunogenicity in HIV-infected, BCG
vaccinated adults with CD3+ >350/mm3 (under review)
• AERAS-402/Crucell Ad35 TB vaccine (AERAS)
• Phase II safety and immunogenicity in BCG vaccinated, HIV
uninfected infants
• Phase II randomised controlled of trial of vaccine prime followed by
selective BCG boost among HIV exposed and unexposed infants
• MVA85A/AERAS-485 booster vaccine (Oxford University)
• P-o-C phase IIb clinical trial to evaluate protective efficacy of
booster MVA85A/AERAS-485 in healthy, HIV-infected adults
TB Vaccines clinical trial sites and
networks: Ag85B-ESAT-6 (H1) + IC31
Phase I (THYB-03)
Clinical trial site: AHRI/ALERT (Ethiopia)
Armauer Hansen Research Institute (Ethiopia), Staten Serum
Institut (Denmark), Leiden University (Netherlands), Institut
Pasteur (Madagascar), Kilimanjaro Medical Centre (Tanzania)
Phase II (THYB-04)
Clinical trial sites: AHRI/ALERT Campus, Butajira, Nazaret, Debre
Zeit (Ethiopia)
Armauer Hansen Research Institute (Ethiopia), SSI (Denmark,
Leiden University Medical Centre (Netherlands),Aarhus University
Hospital (Denmark), Bandim Health Project (Guinea Bissau)
Ag85B-ESAT-6 (H1)+IC31: phase II CT
to evaluate safety and immunogenicity
in HIV-infected adults (Under review)
Phase II double-blind, randomised, placebo-controlled
study to evaluate safety and immunogenicity of Ag85BESAT-6 (H1) + IC31 in HIV-infected, BCG vaccinated
adults with CD4+ counts >350 cells/mm3 with no
evidence of TB disease
Trial sites: Bagamoyo (Tanzania), Johannesburg (S.
Africa)
Aurum Institute (S. Africa), SSI, (Denmark), STI
(Switzerland), Ifakara Health Institute (Tanzania),
AERAS TB Foundation, KNCV (Netherlands), AMC
(Netherlands)
AERAS-402/Crucell Ad35 boost TB vaccine
Randomised, double-blind controlled phase II clinical
trial in BCG vaccinated, HIV uninfected infants to
evaluate safety and immunogenicity
Trial sites: Kisumu, Kampala, Maniça, Worcester
University of Cape Town, SATVI (S. Africa) KEMRI/CDC (Kenya),
Infectious Disease Institute of Makerere University, Makerere
School of Public Health (Uganda) Maniça Health Research
Centre (Mozambique), Hospital Clinic Barcelona, Institute of
Tropical Medicine (Belgium), Swedish Institute of Infectious
Disease Control, Karolinska Institute (Sweden)
AERAS-402/Crucell Ad35 prime TB
vaccine (Under review)
Phase II randomised controlled trial of a new viralvectored tuberculosis vaccine prime followed by
selective BCG boost among HIV exposed and HIV
unexposed infants
Trial sites: Worcester, Kayeletisha (S. Africa), Kisumu
(Kenya)
SATVI-IIDMM-University of Cape Town (S-Africa),
KEMRI/CDC (Kenya), NIMR-MMRP (Tanzania), KI
(Sweden), CHUV (Sweden), Stellenbosch University
(S. Africa)
MVA85A/AERAS-485
P-of-C Phase IIb CT to evaluate protective efficacy of a
recombinant modified vaccinia virus Ankara expressing
immunodominant antigen 85 (MVA85) from M.
tuberculosis in HIV-infected adults using a
heterologous prime-boost strategy with BCG as a
primer
Clinical trials sites: S. Africa, Senegal
Medical Research Council Gambia, University of
Oxford, University of Cape Town, Universitaire Aristide
Le Dantec Dakar, Pasteur Institute Belgium
REMox
Summary of PanACEA Collaborating
Institutions
HIGHRIF
SQ109
Kenya Medical Research
Institute (KEMRI)
Aurum Institute for Health Research
Aurum Institute for Health Research
Kilimanjaro Christian
Medical Centre (KCMC)
Ifakara Health Research and
Development Centre
Ifakara Health Research and
Development Centre
Medical Research Council
South Africa
Kilimanjaro Christian Medical Centre
(KCMC)
Klinikum der Universitat Munchen,
Institute for Medical Bioinformatics
Medical Research Council
UK
Makerere University
Leiden University
Stellenbosch University
National Institute for Public Health
and the Environment (RIVM)
Mbeya Medical Research Programme
University of Cape Town
Lung Institute
Radboud University Nijmegen
Sequella
University College London
Stellenbosch University
Stellenbosch University
University of Zambia
Swiss Tropical Institute
University of Cape Town Lung
Institute
University of Cape Town Lung
Institute
University College London
University College London
University of Tübingen
University of the Witwatersrand
University of Zambia
Main areas of HIV Research &
Development
• Treatment
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Second line – when to switch and to what?
Paediatric treatment
HIV/TB co-infection
Capacity development
• Prevention
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Capacity development
Vaccines
PMTCT
Microbicides
Example of an EDCTP/BMGF HIV capacity
building and vaccine trial project
HIVIS 03 – Phase I/II safety and
immunogenicity of a plasmid DNA-MVA prime
boost HIV-1/TaMoVac I/TaMoVac II
Financial partners
EC, Member States (Germany, Netherlands, Sweden, UK) BMGF,
WRAIR (USA), Vekura (Sweden)
Collaborating institutions
NIMR Mbeya (Tanzania), MUHAS (Tanzania), INS (Mozambique),
MoH (Mozambique), University of Munich (Germany) Imperial
College (UK), MRC (UK), SMI (Sweden), Venhälsan,
Södersjukhuset (Sweden)
The CHAPAS HIV treatment clinical trial
CHAPAS-1 – Phase I/II trial to study pharmacokinetics and
appropriate dosing of and adherence to Pedimune (fixeddose paediatric combination of stavudine, lamivudine and
nevirapine)/CHAP-2/CHAPAS-3
Financial partners
EC, Member States (UK, Spain, Ireland, Italy), Cipla Pharmaceuticals Ltd.
(India)
Collaborating institutions
University Teaching Hospital (Zambia), MRC (UK), Radboud University
MC Nijmegen (Netherlands), San Francisco General Hospital (USA), St
James’ Hospital (Ireland), Mulago Hospital (Uganda), Joint Clinical
Research Centre (Uganda), University of Cape Town (South Africa),
Trinity College Dublin (Ireland)
Main areas of malaria
research
Treatment
Malaria in pregnancy
Severe childhood malaria
Artemisinin combination therapies
Non-Artemisinin combination therapies
Prevention
Intermittent preventive treatment
Malaria vaccines
GMZ2 – Phase I/II
AdCh63 MVA-TRAP Phase I/II
Contributions to EDCTP projects as of
31 August 2010
African
Contribution,
€9,596,067
EDCTP/EC
Contribution,
€124,940,188
M/S National
Programme
Contribution ,
€111,718,958
Third Party
Contribution,
€51,695,453
Thank you
http://www.edctp.org