Efficiency of estimating vaccine efficacy for susceptibility and infectiousness: randomization by individual versus household

Biometrics
S DattaI M Longini

Abstract

In designing vaccine efficacy studies based on the secondary attack rate (SAR) or transmission probability in which both vaccine efficacy for susceptibility, VE(S), and vaccine efficacy for infectiousness, VE(I), are estimated, the allocation of vaccine and placebo within transmission units has an important influence on the efficiency of the study. We compared the following randomization schemes that result in different allocations of vaccine and placebo within two-member households: (1) randomization by individual for a mixed allocation, (2) randomization by transmission unit for concordant allocation, and (3) randomization of only one individual in each transmission unit to either vaccine or placebo. There is a complex interaction among the VE(S), VE(I), and the SAR that determines which allocation of vaccine and placebo within households provides the most information. In general, individual randomization with a mixed allocation of vaccine and placebo is better for estimating both VE(S) and VE(I) than is randomizing by household. However, for estimation of VE(I), at very low SARs and low VE(S), randomization by household is slightly more efficient than randomization by individual.

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Citations

Jul 15, 2011·Epidemiology·Tyler J VanderWeele, Eric J Tchetgen Tchetgen
Sep 2, 2005·Epidemiology·James S KoopmanChris P Riolo
Feb 5, 2013·Epidemiology·Yasutaka Chiba, Masataka Taguri
Sep 16, 2008·Mathematical Biosciences·Lorenzo PellisChristophe Fraser
Aug 16, 2008·Computational Statistics & Data Analysis·Yang YangM Elizabeth Halloran
Nov 16, 2005·Statistics in Medicine·Niels G BeckerPhilip D O'Neill
Aug 6, 2013·Environment International·Zhiwei XuShilu Tong
Nov 12, 2010·Statistical Methods in Medical Research·Eric J Tchetgen Tchetgen, Tyler J VanderWeele

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