S. Datta et al., Efficiency of estimating vaccine efficacy for susceptibility and infectiousness: Randomization by individual versus household, BIOMETRICS, 55(3), 1999, pp. 792-798
In designing vaccine efficacy studies based on the secondary attack rate (S
AR) or transmission probability in which both vaccine efficacy for suscepti
bility, VES, and vaccine efficacy for infectiousness, VEI, are estimated, t
he allocation of vaccine and placebo within transmission units has an impor
tant influence on the efficiency of the study. We compared the following ra
ndomization schemes that result in different allocations of vaccine and pla
cebo within two-member: households: (1) randomization by individual for a m
ixed allocation, (2) randomization by transmission unit for concordant allo
cation, and (3) randomization of only one individual in each transmission u
nit to either vaccine or placebo. There is a complex interaction among the
VES, VEI, and the SAR that determines which allocation of vaccine and place
bo within households provides the most information. In general, individual
randomization with a mixed allocation of vaccine and placebo is better for
estimating both VES and VEI than is randomizing by household. However, for
estimation of VEI. at very low SARs and low VES, randomization by household
is slightly more efficient than randomization by individual.