Statistical issues in the design of HIV vaccine trials

HIV vaccine trials present significant challenges related to trial endpoints, vaccine efficacy measurement, and the role of nonvaccine interventions. Infection is a valid endpoint for detecting sterilizing immunity. But if the vaccine prevents AIDS without preventing infection, infection may be a mi...

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Bibliographic Details
Published in:Annual review of public health 1995-01, Vol.16 (1), p.1-22
Main Authors: Schaper, C, Fleming, T R, Self, S G, Rida, W N
Format: Article
Language:English
Subjects:
AIDS Vaccines - pharmacology
AIDS Vaccines - standards
AIDS/HIV
Clinical Trials as Topic - standards
Clinical Trials as Topic - statistics & numerical data
Health Behavior
HIV Infections - epidemiology
HIV Infections - prevention & control
HIV Infections - transmission
Humans
Research Design
United States - epidemiology
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Summary:HIV vaccine trials present significant challenges related to trial endpoints, vaccine efficacy measurement, and the role of nonvaccine interventions. Infection is a valid endpoint for detecting sterilizing immunity. But if the vaccine prevents AIDS without preventing infection, infection may be a misleading surrogate. Appropriate endpoints must be defined for other mechanisms of vaccine action. Direct, indirect, behavioral, and biological effects all determine vaccine efficacy. False security among HIV-vaccine recipients may make negative behavioral effects an important component of vaccine performance. Both biological potency and a more comprehensive program effectiveness should be measured. These goals may require unblinded designs or community randomization. Nonvaccine interventions are currently the only HIV-prevention strategy. Support for larger scale implementation requires more rigorous evaluation that is less dependent on self-reported behavioral changes. The vaccine trial cohorts provide a unique opportunity to cost-effectively evaluate behavioral interventions.
ISSN:0163-7525
1545-2093
DOI:10.1146/annurev.pu.16.050195.000245