WHO/IVB/05.17 ORIGINAL: ENGLISH Creating national and regional frameworks to support HIV vaccine development in developing countries Report from a WHO-UNAIDS consultation ILausanne, Switzerland, 2–3 September 2004 VImmunization,B Vaccines and Biologicals WHO/IVB/05.17 ORIGINAL: ENGLISH Creating national and regional frameworks to support HIV vaccine development in developing countries Report from a WHO-UNAIDS consultation ILausanne, Switzerland, 2–3 September 2004 VImmunization,B Vaccines and Biologicals The Department of Immunization, Vaccines and Biologicals thanks the donors whose unspecified financial support has made the production of this document possible. This document was produced by the Initiative for Vaccine Research Team of the Department of Immunization, Vaccines and Biologicals Ordering code: WHO/IVB/ 05.17 Printed: October 2005 This publication is available on the Internet at: www.who.int/vaccines-documents/ Copies may be requested from: World Health Organization Department of Vaccines and Biologicals CH-1211 Geneva 27, Switzerland • Fax: + 41 22 791 4227 • Email: [email protected] • © World Health Organization 2005 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel: +41 22 791 2476; fax: +41 22 791 4857; email: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; email: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either express or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. The views expressed in documents by named authors are solely the responsibility of those authors. Printed by the WHO Document Production Services, Geneva, Switzerland ii Contents Preface ............................................................................................................................... v Acknowledgements ........................................................................................................ vii Abbreviations and acronyms ......................................................................................... ix 1. Science and planning for HIV vaccine strategy ............................................ 1 1.1 Pipeline HIV vaccines and key scientific issues to be addressed in clinical trials ........................................................................... 1 1.2 Recruiting and retaining women in HIV vaccine clinical trials ............ 2 1.3 Needs and requirements for clinical trials evaluation ............................ 3 1.4 Challenges to move HIV vaccine development through all phases of clinical trials ........................................................................... 4 1.5 Summary of recommendations from the WHO-UNAIDS Consultation on Gender, Age and Ethnicity ........................................... 5 1.6 Discussion ..................................................................................................... 6 2. Experiences in conducting clinical trials in developing countries .............. 7 2.1 HIV vaccine trials in Thailand ................................................................... 7 2.2 HIV vaccine trials in South Africa............................................................ 9 2.3 HIV vaccine trials in Botswana ................................................................. 9 2.4 HIV vaccine trials in Brazil ..................................................................... 10 2.5 HIV vaccine trials in Kenya .................................................................... 11 2.6 Discussion ................................................................................................... 12 3. Policy mechanisms for reviewing and approving clinical trials ................ 14 3.1 Regulating clinical trials: scientific considerations ............................... 14 3.2 Review and approval of HIV clinical trials in Peru .............................. 16 3.3 Roundtable discussion: Country experiences for the review/approval of HIV clinical trials.................................................... 17 3.4 Strengthening national regulatory authority functions ........................ 18 3.5 Discussion ................................................................................................... 19 4. Ethics, legal issues, and community participation ...................................... 20 4.1 Responding to the ethical and legal challenges of HIV vaccine development in Africa ................................................................ 20 4.2 Treating people with intercurrent infection in HIV prevention trials ......................................................................................... 21 4.3 Legal issues................................................................................................. 22 4.4 Issues in community participation........................................................... 22 4.5 Discussion ................................................................................................... 25 iii 5. Developing national and regional plans and strategies .............................. 26 5.1 Introduction to the AAVP guidance document on national HIV vaccine plans ..................................................................................... 26 5.2 Examples of other countries’ national plans/strategies ........................ 27 5.3 Other global initiatives ............................................................................. 32 5.4 Discussion ................................................................................................... 37 6. Working groups: approaches for the development of regional networks............................................................................................... 39 6.1 General recommendations ........................................................................ 39 6.2 Recommendations for WHO and UNAIDS ......................................... 40 6.3 Policy recommendations ........................................................................... 41 List of participants ....................................................................................................... 42 iv Preface Dr Marie-Paule Kieny, Director of WHO’s Initiative for Vaccine Research (IVR), welcomed participants and gave a brief overview of the organizational structure of IVR. Dr Saladin Osmanov, Acting Coordinator for the WHO-UNAIDS HIV Vaccine Initiative provided opening remarks. Thirteen years ago, WHO recommended developing vaccine trial sites in developing countries, including Thailand, Rwanda, Uganda, and Brazil. At that time, HIV vaccine trials were a long-term objective. Over the years, the panorama has changed thanks to careful, long-term planning and preparation. Today, these four pioneering countries (now three because Rwanda could not continue) have been conducting all phases of vaccine trials. They have shown us that developing national plans is insufficient without multiple collaborators and links to international partners. Trials must be owned by the countries and monitored with their own regulations. Through this work over the years, WHO recognizes that there are many common issues, not only in countries’ national plans, but also within regions. These issues can best be tackled through peer support and collaboration. Issues are related to ethics, regulatory, community participation, legal and human rights—and can be resolved at the regional level through planning. Another factor is that number of sponsors of HIV vaccine trials in developing countries has expanded to include the United States National Institutes of Health (NIH), Walter Reed Army Institute (WRAI), European platform, International AIDS Vaccine Initiative (IAVI), Italian government, Global HIV Vaccine Enterprise, and others. For these reasons HIV vaccine development is going through period of new thinking. The objectives of this meeting on national planning are outlined below. • Review progress and discuss key scientific challenges relevant to HIV vaccine development and evaluation. • Discuss issues/challenges for the development of national AIDS vaccine plans. • Discuss policies and mechanisms for reviewing and approving research protocols. • Discuss the regulatory, legal, and ethical