Impact of stochastically generated heterogeneity in hazard rates on individually randomized vaccine efficacy trials.

ABSTRACT: Background/aims Network structure and individuals' level of exposure to a pathogen can impact results from efficacy evaluation studies of interventions against infectious diseases. Heterogeneity in infection risk can cause randomized groups to increasingly differ as a trial progresses and as more high-risk individuals become infected (described in prior work as the "frailty" phenomenon). Here, we show the impact this phenomenon can have on an individually randomized trial of a leaky vaccine in which all participants are exchangeable a priori. Methods We model a vaccine trial by generating a network of individuals grouped into communities, which are connected to a larger main population. We then simulate an epidemic, deterministically and with time-varying transmission rates in the main pop

SUBMITTER: Kahn R 

PROVIDER: S-EPMC5891371 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature