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J Infect Dis. 2009 Aug 15;200(4):609-13. doi: 10.1086/600891.

Power to detect the effects of HIV vaccination in repeated low-dose challenge experiments.

Author information

1
Department of Biostatistics, School of Public Health, University of North Carolina, Chapel Hill, NC 27599, USA. mhudgens@bios.unc.edu

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.

PMID:
19591571
PMCID:
PMC2754821
DOI:
10.1086/600891
[Indexed for MEDLINE]
Free PMC Article
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