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A new collaborative model of research is needed to increase resources, to prioritize the RD (ii) to increase the pace, reduce the overlap, and more systematically explore the elements of and delivery systems for vaccines; (iii) to use common standards for the prompt comparative testing of vaccine candidates; (iv) to expand resources for manufacturing vaccine candidates to speed their use in human trials; and (v) to increase the capacity for international clinical trials and to focus this effort toward quickly measuring the effectiveness of vaccine protection as prototype vaccine candidates are identified.

The need to broaden research directed at answering fundamental questions in HIV vaccine discovery through laboratory, nonhuman primate (NHP), and clinical research has recently been emphasized. In addition, the importance of attracting and retaining young researchers, developing better NHP models, and more closely linking NHP and clinical research is being stressed. In an era of a level budget for biomedical research at the U.S. National Institutes of Health (NIH), HIV/AIDS vaccine research efforts will need to be carefully prioritized such that resources to energize HIV vaccine discovery can be identified. This article summarizes progress and challenges in HIV vaccine research, the priorities arising from a recent summit at NIAID, and the actions needed, some already under way, to address those priorities.

Since the discovery of human immunodeficiency virus (HIV) in 1983, significant progress has been made toward the discovery, development, and licensing of anti-HIV drugs. In vitro screens against whole virus are now being complemented by screens against specific viral targets, resulting in the development of clinical candidates acting at several critical stages of the viral life cycle. Despite these advances, clinical therapy remains largely palliative. In addition, it has recently been recognized that HIV resistance to most drugs may pose even greater obstacles. Moreover, emerging data on immunopathogenesis raise the possibility that even if virus was eliminated from an infected individual, the patient's immune system might not be capable of restoration to normal function. In the face of such obstacles, deeper insights into the pathogenic mechanisms of disease, aggressive exploitation of those mechanisms for therapeutic gain, and continued commitment of both public and private sectors to support and collaborate in this research are needed.

In this Policy Forum, the [authors][1] respond to [ Burton et al .][2] by asserting that the ongoing efficacy trial of ALVAC-HIV (vCP1521) and AIDSVAX B/E in Thailand is scientifically justified, morally correct, and strategically important. No laboratory assay or animal model has been validated as a predictor of the efficacy of HIV vaccines in humans, thus efficacy trials are essential to test bona fide vaccine hypotheses. Although there is a real chance that the prime-boost combination may not be efficacious, there is a very high probability that information gained will significantly advance HIV vaccine development. Established scientific principles and appropriate processes fully support the decision to proceed with this efficacy trial. [1]: http://www.sciencemag.org/cgi/content/full/303/5660/961 [2]: http://www.sciencemag.org/cgi/content/short/303/5656/316