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O’Hagan et al. [1] offer an alternate explanation for the apparent decline in efficacy over time in vaccine and microbicide trials. They propose that the decline in efficacy observed could also be explained by selection bias due to heterogeneity in infection risk. As those at highest risk are infected more in the placebo arm than in the active arm, it leads to differences in the composition of the study population in the two study arms, a phenomenon called frailty in statistics [1].

Declining adherence is a more likely explanation than frailty of the apparent decline in efficacy in the CAPRISA 004 trial