Abstract
AbstractThe Global HIV Vaccine Enterprise (the Enterprise) convened a two-day workshop on 17-18 September 2009, at the Enterprise offices in New York; to discuss approaches to bridging the gaps between fundamental,preclinical and clinical HIV vaccine research. The topic of this Working Group originated from discussions of the Enterprise Science Committee,which proposed that more effective collaboration between these three areas of HIV vaccine research is needed in order to accelerate the pace of scientific progress in the field. Because the meeting took place before the release of the RV144 trial results held in Thailand, the conclusions reached during the meeting were further discussed during consultations at scientific conferences and at a joint meeting of the Science Committee and Chairs of all five Working Groups. Thus, this Report reflects both the original discussions of the Working Group and subsequent discussions that took place after the release of the RV144 trial results.
Highlights
The Global HIV Vaccine Enterprise convened a two-day workshop on 17-18 September 2009, at the Enterprise offices in New York; to discuss approaches to bridging the gaps between fundamental, preclinical and clinical HIV vaccine research
During the meeting, Working Group members emphasized the unique role of efficacy trials in testing the ability of different vaccine concepts to induce protective immune responses in humans
It is imperative to recognize that the efficacy trial(s) may not lead to a licensable product; as such, we have to do a better job of integrating scientific inquiry into trial protocols from the beginning to maximize learning opportunities
Summary
The Global HIV Vaccine Enterprise (the Enterprise) convened a two-day workshop on 17-18 September 2009, at the Enterprise offices in New York; to discuss approaches to bridging the gaps between fundamental, preclinical and clinical HIV vaccine research. Failure of the VaxGen candidate to induce immunological protection[2] accelerated the shift in the field toward cell-based vaccines; the early termination of the Step trial[3] was viewed by many as the failure of a cellbased vaccine strategy; while the results of the RV144 trial[1] have brought new attention to the possible role of innate immune responses and non-neutralizing antibody functions as keys to achieving protection and the importance of CD4+ T cell responses after vaccination These shifts in the conceptual framework on how to best design an effective HIV vaccine reflect both the current very limited understanding of the pathways to immunological protection[4], and the view that the main purpose of efficacy trials is to advance a vaccine product toward licensure. Concentrating on the initial 1-10 days after inoculation would require altering the way most NHP experiments are designed and conducted
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