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EDCTP: Past and present
Consensus Meeting on EDCTP-II
27-28 September 2010
BrusselsCharles 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
• Coordination of national programmes
• Partnerships
• Capacity development
• Networking
EDCTP Governance
• General Assembly (Policy making)• Participating European Member States• African representatives
• 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
Capacity development
MSc and PhD scholarships 121Ethics and Regulatory Authority support 43Career Development and Senior Fellowships 36
EDCTP Networks of Excellence for conducting clinical trials
• 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
Sub-Saharan African countries
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
Receptionist
Interviews and vitals
Mantoux
Chest X-rayMobile x-ray truck
CO reading X-ray
Sputum and Treatment
Data Centre
Mobile Field Site (MFS)
ACS- Overview
Nursing Station 1 Nursing Station 2
Clinical OfficerX-Ray Station
Receptionist/Dispatcher
Server (Wireless LAN)
-Receives the participant-Logs participant into system-Activates movement-Appends Bar codes on consent forms-Logs out participant once through
-Takes Demographic data-Takes Clinical history, contact history-updates movement to nurse 2
-Administers TST-Takes vital measurements
Common Ailment
TB Suspect
-Takes X-ray, Completes X-ray Screen
X-Ray Taken
-Reads X-ray into CRRS-Takes clinical Notes
-Sample Received in Kisian Lab-Keyed into Lab Module Reception screen
Back up in Kisian
TB Suspect
Common Ailment
Not suspect/No Common Ailment
-Pre-Enrolment Screening-Alerts
Terra byte external drive backups
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)TBVACVakzine Projekt Management GmbHWorld Health OrganisationSouth 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 Ag85B-ESAT-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, WorcesterUniversity 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 viral-vectored 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, SenegalMedical Research Council Gambia, University of Oxford, University of Cape Town, Universitaire Aristide Le Dantec Dakar, Pasteur Institute Belgium
Summary of PanACEA Collaborating Institutions
REMox 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• Second line – when to switch and to what?• Paediatric treatment• HIV/TB co-infection• Capacity development
• Prevention• 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 partnersEC, Member States (Germany, Netherlands, Sweden, UK) BMGF, WRAIR (USA), Vekura (Sweden)
Collaborating institutionsNIMR 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 (fixed-dose paediatric combination of stavudine, lamivudine and nevirapine)/CHAP-2/CHAPAS-3
Financial partnersEC, Member States (UK, Spain, Ireland, Italy), Cipla Pharmaceuticals Ltd. (India)
Collaborating institutionsUniversity 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
TreatmentMalaria in pregnancySevere childhood malariaArtemisinin combination therapiesNon-Artemisinin combination therapies
PreventionIntermittent preventive treatmentMalaria vaccines
GMZ2 – Phase I/IIAdCh63 MVA-TRAP Phase I/II
Contributions to EDCTP projects as of 31 August 2010
