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FROM KAMPALA TO CAPE TOWN
1) This document discusses the challenges and opportunities for conducting HIV vaccine clinical trials across Africa. It outlines several networks that conduct such trials, including ongoing studies in South Africa, Tanzania, Kenya, and other countries. 2) Regulatory approval for clinical trials can often be a lengthy process, taking over 100 days on average for some studies. Harmonization of regulatory systems and increasing local expertise could help address challenges. 3) International collaboration and engagement with local stakeholders is important for ensuring trials are conducted effectively and ethically. Capacity building aims to strike the right balance between scientific goals and respecting local contexts.
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FROM KAMPALA TO CAPE TOWN
- 1. FROM KAMPALA TOCAPE TOWN A JOURNEY ON THE HIV VACCINE NETWORKS HIGHWAY ROGER TATOUD, PH.D. SENIOR PROGRAMME MANAGER (TRANSLATIONAL RESEARCH, HIV) UK HIV VACCINE CONSORTIUM IMPERIAL COLLEGE LONDON 1
- 2. Adult HIV Prevalence2013 (UNIADS 2013) HIV Vaccine Trial Sites (IAVI Database) 2
- 3. AN IDEAL NETWORKFOR CONDUCTING HIV VACCINE STUDIES Good clinical infrastructure (clinics, health centres, pharmacy, bio- banking, archiving facilities) GCP-certified laboratories for immunoassays Data management facilities Good communication infrastructure (road/internet) Qualified staff (GCP, GLP): Clinicians, social scientists, pharmacists, nurses, lab staff Community Advisory Board (CAB/CAG) Relevant participants Local and national support 3
- 4. AFREVACC PARTNERSHIP ImperialCollege London Medical Research Council Clinical Trials Unit (UK) Fundació Clinic per la Recerca Biomédica (Spain) University of Munich (Germany) Amsterdam Institute for Global Health Development (Netherlands) Wits Reproductive Health & HIV Institute (South Africa) Africa Centre for Health and Population Studies (South Africa) Centre Hospitalier Universitaire Lausanne (Switzerland) Contract Laboratory Services (South Africa) Universidade Catolica de Moçambique, Beira (Mozambique) Manhica Health Centre (Mozambique) Mbeya Medical Research Programme (Tanzania) The network was established in 2008 to explore HIV vaccine development and build HIV vaccine trial capacity in South Africa, Tanzania & Mozambique. 4
- 5. MAJOR HIV VACCINENETWORKS 5 HVTN: Public and private sources, the National Institute of Allergy and Infectious Diseases (NIAID) is the main funder and another significant funding source is the Bill & Melinda Gates Foundation (BMGF). IAVI: Government, Multilateral, Foundation, Corporate EDCTP: EU and government co- funding SAAVI
- 6. HIV VACCINE TRIALSIN AFRICA Sources IAVI Database ClinicalTrials.gov AVAC Colleagues Known status Able to start Prophylactic (37) Therapeutic (3) 6 3 11 3 2 1 6 14 1 5 1 1 14
- 7. ONGOING HIV VACCINESTUDIES 7 Ph. Name Status Strategy Immunogens Ppts Countries I RV262 Ongoing DNA Viral Vector - Pox Pennvax-G (env-gag) MVA-CMDR 92 Kenya, Tanzania, Uganda, USA I IAVI S001 Ongoing Viral Vector – Replicating Viral Vector - Adeno SeV-G (replicating) Ad35-GRIN 64 Kenya, United Kingdom, Rwanda I HVTN 086, SAAVI 103 Ongoing Viral Vector – Pox DNA Protein SAAVI MVA-C SAAVI DNA-C2 Oligomeric gp140/MF59 184 South Africa I HVTN 097 Ongoing Viral Vector – Pox Protein ALVAC-HIV vCP1521 AIDSVAX B/E 100 South Africa I/II IAVI N004 HIV-CORE 004 Ongoing Viral Vector – Adeno Viral Vector – Pox DNA Ad35-GRIN MVA.HIVconsv pSG2.HIVconsv 72 Kenya I/II HVTN 084 Ongoing Viral Vector – Adeno Viral Vector - Adeno VRC-HIVADV054-00-VP (gag-pol) VRC-HIVADV014-00-VP 100 Peru, Brazil, USA, Swaziland II TaMoVac II (AFV) Ongoing DNA Viral Vector - Pox Protein HIVIS-DNA MVA-CMDR GP140+GLA 198 Tanzania, Mozambique Horizon 2020 and EDCTP 2 are coming…
- 8. REGULATORY APPROVALS StraightAhead! 8
- 9. PRODUCT DEVELOPMENT PATH9 Basic research Prototype Discovery & Design Pre-clinical Develop- ment Early clinical trials (I/II) Late clinical trials (III/IV) Regulatory approval Marketing Post marketing compliance Patient 32 years and counting 2-5 years 3-10 years 1-2 years Product Manufacture 1-2 years Product Manufacture • R&D • Ethics • Relevance • Design • Risk/Benefit • Patient information & consent • Investigator competence • Clinical Trial Authorisation • Sponsorship • Investigator competence • Manufacture (IB/IMPD) • Safety • Protocol • IMP management (labelling/Stability) • Monitoring • Management (Trial, Product, Data) Knowledge
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- 12. CASE STUDY 1- SATVI TB VACCINE TRIAL 92 Applications for 16 TB vaccine trials (32/60) between 2004-2012 MCC & UCT Faculty of health Science HREC (S. Af.) Median approval time for first submission to MCC was 122 days (IQR 112 - 168; range 71 - 350) Approval time for amendment submissions to the MCC was 103 days (IQR 76 - 141, range 23 - 191) Median approval time for first submission to HREC was 60 days (IQR 33 - 81; range 18 - 125). For amendment submissions to HREC, median was 6 days; IQR 4 - 13; range 1 – 37) No difference in approval time by clinical phase, year of submission, calendar month of submission, sponsor, PI, age of study participants, sample size, or use of a CRO for either MCC or HREC submission 12 Geldenhuys, et al., S Afr Med J 2013;103(2):85-89.
- 13. CASE STUDY 2– PRODUCT SHELF-LIFE EXTENSION TaMoVac II: EDCTP funded Phase II placebo controlled study Led by Prof. Eligius Lyamuya (MUHAS) sponsored by SMI. Site in Tanzania and Mozambique (Ilesh Jani) 6 arms study with multiple products and devices 0 4 12 24 40 13 7 DNA Plasmids (KI/SMI) Env A,B,C Gag A,B RT B Rev B MVA NIH/WRAIR Env E, Gag A, Pol A With or Without GP140+GLA (bedside mix) UK HVC
- 14. Sponsor Manufacturer 3 Distributor Manufacturer 2 Manufacturer 1 Tanzanian sites Mozambique Site 14
- 15. POTENTIAL REGULATORY CHALLENGESIN INTERNATIONAL CLINICAL TRIALS Research priority Limited expertise and capacity of local regulatory bodies Conflicting ethos of funders, researchers and regulators Multiple layers of reviews with inconsistent findings Importation process Variation in standard for participant compensation for trial-related injury Increased scrutiny and restriction of bio-banking and repository research Ownership of data, samples and publication rights Post study drug provision and long term commitment to the provision of treatment Civil society awareness and understanding of clinical research (public pressure) Adapted from Ndebele et al., JAIDS 65(S1):S29, 2014 15
- 16. IMPACT OF POORLY-RESOURCEDREGULATORY SYSTEMS Increase costs Complicate operational planning by sponsors and researchers Create further delay Threaten successful completion of trial Impact on scientific validity of clinical research Lead to frustration and distrust in the system Affect perception of clinical research by participants, the public and the international communities at large 16
- 17. HOW TO MAKEIT WORK BETTER? Understand the purpose of the regulatory requirements and processes • STEP, Ebola • Multi-component trials • Manufacturing processes, product shelf-life, timelines 17 Engaging with existing regulatory structures • EDCTP: MARC (Mapping of the capacity to ethically review health research) • WHO: AVAREF (African Vaccine Regulatory Forum) • African Medicines Building local capacity • Regulatory Harmonisation Initiative Mindfulness of what it means to conduct research in developing countries African stakeholders to take leadership Moving towards a single Pan-African regulatory body (similar to EU) • EDCTP-funded Pan African Clinical Trials Registry (PACTR) Working together to strike the right balance
- 18. AKNOWLEDGEMENTS Sarah Joseph(MRC-CTU at UCL) Phil Bergin (IAVI) Merlin Robb (WRAIR) Sheena McCormack (MRC-CTU at UCL) Eligius Lyamuya and Muhammad Bakari (TaMoVac - Tanzania) Bindiya Meggi (TaMoVac – Mozambique) IAVI AVAC Sue Marlow Kate Skinner (Holden-Dye) 18