Power to detect the effects of HIV vaccination in repeated low-dose challenge experiments.
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.
Hudgens
Michael G
MG
Department of Biostatistics, School of Public Health, University of North Carolina, Chapel Hill, NC 27599, USA. mhudgens@bios.unc.edu
Gilbert
Peter B
PB
Mascola
John R
JR
Wu
Chih-Da
CD
Barouch
Dan H
DH
Self
Steven G
SG
D016915:AIDS Vaccines / Q000276:immunology*; D000818:Animals; D003198:Computer Simulation; D003627:Data Interpretation, Statistical; D006801:Humans; D008954:Models, Biological; D015233:Models, Statistical; D012107:Research Design
D016915:AIDS Vaccines