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Article
Power to detect the effects of HIV vaccination in repeated low-dose challenge experiments.
Journal of Infectious Diseases (2009)
  • Peter B. Gilbert
  • Michael G. Hudgens, University of North Carolina at Chapel Hill
  • C Wu, University of North Carolina at Chapel Hill
  • Dan Barouch, Harvard Medical School
  • John Mascola
  • Steve Self
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.
Publication Date
2009
Citation Information
Peter B. Gilbert, Michael G. Hudgens, C Wu, Dan Barouch, et al.. "Power to detect the effects of HIV vaccination in repeated low-dose challenge experiments." Journal of Infectious Diseases Vol. 200 (2009)
Available at: http://works.bepress.com/peter_gilbert/17/