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EDCTP: Past and present Consensus Meeting on EDCTP-II 27-28 September 2010 Brussels Charles S Mgone EDCTP Executive Director.

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Presentation on theme: "EDCTP: Past and present Consensus Meeting on EDCTP-II 27-28 September 2010 Brussels Charles S Mgone EDCTP Executive Director."— Presentation transcript:

1 EDCTP: Past and present Consensus Meeting on EDCTP-II September 2010 Brussels Charles S Mgone EDCTP Executive Director

2 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)

3 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, malariaand other diseases MDG 8 – To develop a global partnership for development

4 Working in partnerships Participating European Member States Sub-Saharan African Countries European Commission Like-minded Organisations International Development Partners PDPs Pharma/SMEs Coordination of national programmes Partnerships Capacity development Networking

5 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)

6 EDCTP Scope

7 The EDCTP approach

8 Current project portfolio

9 Clinical trials portfolio Drugs13 Vaccines8 Microbicides4 HIV/AIDS 25 clinical trials Drugs8 Vaccines8 Diagnostics3 Tuberculosis 19 clinical trials Drugs10 Vaccines2 Malaria 12 clinical trials

10 Capacity development MSc and PhD scholarships 121 Ethics and Regulatory Authority support43 Career Development and Senior Fellowships36

11 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 PRDs Clinical Trials - HIV Clinical Trials – Malaria Clinical Trials – TB Training Awards Ethics Capacity Strengthening Regulatory Capacity Strengthening Networking projects

12 Participating countries Benin Botswana Burkina Faso Cameroon Congo Cote dIvoire Democratic Republic of Congo Ethiopia Gabon Ghana Guinea Guinea-Bissau Kenya Liberia Madagascar Malawi Mali Mozambique Namibia Nigeria Rwanda Senegal South Africa Sudan Tanzania The Gambia Uganda Zambia Zimbabwe Austria Belgium Denmark France Germany Greece Ireland Italy Luxembourg Netherlands Norway Portugal Spain Sweden Switzerland United Kingdom EDCTP-EEIG member states Sub-Saharan African countries

13 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

14 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

15 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

16 Receptionist Interviews and vitals Mantoux Chest X-ray Mobile x-ray truck CO reading X-ray Sputum and Treatment Data Centre Mobile Field Site (MFS)

17 ACS- Overview Nursing Station 1Nursing Station 2 Clinical Officer X-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

18 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

19 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/mm 3 (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

20 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)

21 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/mm 3 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)

22 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 HealthResearch Centre (Mozambique), Hospital Clinic Barcelona, Institute of Tropical Medicine (Belgium), Swedish Institute of Infectious Disease Control, Karolinska Institute (Sweden)

23 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)

24 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

25 Summary of PanACEA Collaborating Institutions REMoxHIGHRIFSQ109 Kenya Medical Research Institute (KEMRI) Aurum Institute for Health Research Kilimanjaro Christian Medical Centre (KCMC) 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 UniversityLeiden University Stellenbosch UniversityNational Institute for Public Health and the Environment (RIVM) Mbeya Medical Research Programme University of Cape Town Lung Institute Radboud University NijmegenSequella University College LondonStellenbosch University University of ZambiaSwiss Tropical InstituteUniversity of Cape Town Lung Institute University College London University of Tübingen University of the Witwatersrand University of Zambia

26 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

27 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)

28 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 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)

29 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

30 Contributions to EDCTP projects as of 31 August 2010

31 Thank you


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