 |
119 Susan Buchbinder San Francisco Dept of Publ Hlth, CA, USA |
Background: HIV vaccine efficacy must be evaluated through large clinical trials. Two such efficacy trials have been conducted to date; many lessons can be learned through analysis of these trials. A number of new products have entered clinical testing and may be ready for efficacy evaluation within the next several years. Decisions will need to be made about which product or combination of products should be advanced to efficacy trials. Future trial designs should optimize our ability to detect immune correlates of protection; if such correlates are detected, even products with fairly low overall efficacy estimates could substantially speed development of more highly protective products or combinations of products. Trials should enroll participants who are representative of the at-risk populations for whom the vaccines are intended. Global trials can address the relative importance of distance between vaccine prototypic sequences and viral sequences in infected trial participants. Participants becoming HIV-infected during efficacy trials will require long-term follow-up and access to standardized treatment regimens to determine vaccine effects on post-infection endpoints. Trials designed to directly evaluate vaccine effects on HIV transmission will likely require community-level randomization. Coordination will be required between vaccine efficacy trials and efficacy trials of non-vaccine based approaches (e.g., microbicides, treatment of sexually transmitted diseases) as these trials often rely on the same pool of investigators and similar populations. Conclusions: Many challenges remain in planning for future vaccine efficacy trials. Only by actively engaging investigators, industry and community members now in planning for efficacy trials will we address these challenges and maximize the information coming from future HIV vaccine efficacy trials.
Keywords: T cell responses; HCV; CD4, CD8 T cells
