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Science 13 February 2004:
Vol. 303. no. 5660, p. 961
DOI: 10.1126/science.1096161
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Policy Forum

POLICY REBUTTAL:
HIV Vaccine Trial Justified

John G. McNeil,1* Margaret I. Johnston,1 Deborah L. Birx,2 Edmund C. Tramont1

In this Policy Forum, the authors respond to Burton et al. 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.

The authors are with 1National Institute of Allergy and Infectious Diseases, Bethesda, MD 20892, and 2Walter Reed Army Institute of Research, Washington, DC 20307, USA.

*To whom correspondence should be addressed. E-mail: jomcneil{at}mail.nih.gov

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THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES:
Systemic Immunization with an ALVAC-HIV-1/Protein Boost Vaccine Strategy Protects Rhesus Macaques from CD4+ T-Cell Loss and Reduces both Systemic and Mucosal Simian-Human Immunodeficiency Virus SHIVKU2 RNA Levels..
R. Pal, D. Venzon, S. Santra, V. S. Kalyanaraman, D. C. Montefiori, L. Hocker, L. Hudacik, N. Rose, J. Nacsa, Y. Edghill-Smith, et al. (2006)
J. Virol. 80, 3732-3742
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Development of an AIDS vaccine: perspective from the South African AIDS Vaccine Initiative.
T. J Tucker and G. Mazithulela (2004)
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