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Power to Detect the Effects of HIV Vaccination in Repeated Low‐Dose Challenge Experiments

Year: 2009

Type: article

Abstract: Simulation studies were conducted to estimate the statistical power of repeated low-dose challenge experiments performed in nonhuman primates to detect the effect of a candidate human immunodeficiency virus vaccine. The effect of various design parameters on power was explored. Results of simulation studies indicate that repeated low-dose challenge studies with a total sample of size 50 (25 animals/arm) typically provide adequate power to detect a 50% reduction in the per-exposure probability of infection resulting from vaccination. Power generally increases with the maximum number of allowable challenges per animal, the per-exposure risk of infection in control animals, and the proportion of animals susceptible to infection.

Source: The Journal of Infectious Diseases

DOI: 10.1086/600891

Authors: Michael G. Hudgens, Peter B. Gilbert, John R. Mascola, Chih‐Da Wu, Dan H. Barouch, Steven G. Self