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Activity Number:
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517
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Type:
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Contributed
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Date/Time:
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Thursday, August 10, 2006 : 8:30 AM to 10:20 AM
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Sponsor:
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Biometrics Section
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| Abstract - #307614 |
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Title:
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Design and Analysis of Neutralizing Antibody Assays in HIV-1 Vaccine Trials
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Author(s):
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Yunda Huang*+ and Peter Gilbert and David Montefiori and Steve Self
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Companies:
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Fred Hutchinson Cancer Research Center and Fred Hutchinson Cancer Research Center/University of Washington and Duke University Medical Center and University of Washington
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Address:
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Statistical Center for HIV/AIDS Research and Prevention, Bellevue, 98008,
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Keywords:
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AIDS ; cross-reactive ; neutralizing antibody ; potency ; M-B curves
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Abstract:
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An effective HIV vaccine must induce potent neutralizing antibody (Nab) responses against a wide range of circulating viruses. Magnitude and breadth (M&B) of neutralization is the main endpoint for comparing antibody-based HIV-1 vaccine candidates in Phase I and II trials and for advancing candidates to Phase III trials. In Phase III trials, M&B of neutralization is also a key marker to evaluate as a putative surrogate endpoint for protection against HIV infection. In this paper, we discuss different approaches to integrating M&B in the design of HIV vaccine trials and analysis of Nab data. We provide suggestions on the summarization and group comparison of multivariate Nab data when left censoring often occurs. Applications to Nab response data from the recent first HIV vaccine efficacy trial will be discussed. Sample size calculations based on simulations will also be presented.
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