Endpoint Assays in HIV-1 Vaccine Trials: Functioning in a Good Laboratory Practices Environment
An HIV-1 vaccine is the best public health tool for stemming the AIDS pandemic, now in its third decade. Studies from HIV-1 infected humans who control infection, animal model experiments, as well as historic experience with licensed vaccines suggest that both virus specific T cells (CD8+ and CD4+) and neutralizing antibodies are two key effector responses that separately, or in combination can provide partial to complete protective immunity. While significant methodological strides have been made in our understanding of anti-viral cell responses, there are still no laboratory assays to predict protective immunity in humans to an HIV-1 vaccine. Consequently, validated and robust laboratory data are needed define the quantity and quality of immune responses that might alter the course of individual and global HIV-1 infection. These data can provide a bar by which to compare immune responses from early clinical trials and to prioritize candidate vaccines for efficacy testing. © 2008 John Wiley & Sons, Ltd.
D'Souza, P; Cox, JH; Ferrari, G; Kunwar, NT; Polonis, V; Sarzotti-Kelsoe, M
- Validation of Cell-Based Assays in the GLP Setting: A Practical Guide
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International Standard Book Number 13 (ISBN-13)
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