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HIV-1 Vaccine Testing, Trial Design, and Ethics

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AIDS in Africa

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Conclusion

To minimize the time until practical and efficacious HIV-1 vaccines are widely distributed in Africa, it is important to continually conduct vaccine preparedness studies and standardized, comparative Phase I and II screening trials of multiple vaccines in many cohorts and geographic locations, and to move the most promising candidates rapidly into efficacy trials. Efficacy trials are needed to assess vaccine effects on susceptibility to HIV-1 infection, infectiousness, disease progression, and behavior, as well as to identify immune and viral correlates of vaccine protection. Since evaluations of vaccine efficacy on infectiousness and disease will rely to some degree on unvalidated surrogate markers such as viral load, it is important to follow HIV-1-infected participants long enough to observe clinical outcomes. Given the differences among populations in many factors including host and viral genetics and routes of exposure, it is also important to carry out multiple, parallel efficacy trials in several high-incidence regions and populations in Africa and elsewhere (67). The success of these trials should be judged not by demonstration of efficacy but by the contribution they make toward the identification of efficacious vaccines (29,123). The ethical validity of an HIV-1 vaccine trial will ultimately depend on the balance of risks and benefits of the proposed research and on its relevance to its intended population, including access to a vaccine that has been shown to be safe and effective.

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Authors and Affiliations

  1. Department of Biostatistics, University of Washington, Seattle, Washington, USA

    Peter B. Gilbert

  2. WHO-UNAIDS HIV Vaccine Initiative, World Health Organization, Geneva, Switzerland

    José Esparza

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  1. Peter B. Gilbert
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  2. José Esparza
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Editors and Affiliations

  1. Harvard AIDS Institute Mary Woodard Lasker Professor of Health Sciences Harvard University, Boston, Massachusetts, USA

    Max Essex DVM, PhD (Chairman) & Richard G. Marlink MD (Senior Research and Executive Director) (Chairman) &  (Senior Research and Executive Director)

  2. Laboratory of Bacteriology and Virology CHU Le Dantec, Université Cheikh Anta Diop, Dakar, Senegal

    Souleymane Mboup PharmD, PhD (Professor of Microbiology) (Professor of Microbiology)

  3. Department of Immunology and Infectious Diseases and the Harvard AIDS Institute, Harvard School of Public Health, Boston, Massachusetts, USA

    Phyllis J. Kanki DVM, DSc (Professor of Immunology and Infectious Diseases) & Molly Holme (Professor of Immunology and Infectious Diseases) & 

  4. Department of Nursing Education University of Botswana, Gaborone, Botswana

    Sheila D. Tlou PhD (Associate Professor) (Associate Professor)

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© 2002 Kluwer Academic Publishers

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Gilbert, P.B., Esparza, J. (2002). HIV-1 Vaccine Testing, Trial Design, and Ethics. In: Essex, M., Mboup, S., Kanki, P.J., Marlink, R.G., Tlou, S.D., Holme, M. (eds) AIDS in Africa. Springer, Boston, MA. https://doi.org/10.1007/0-306-47817-X_40

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  • DOI: https://doi.org/10.1007/0-306-47817-X_40

  • Publisher Name: Springer, Boston, MA

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  • Online ISBN: 978-0-306-47817-8

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