Incorporating founder virus information in vaccine field trials.

ABSTRACT: Vaccine clinical trials with active surveillance for infection often use the time to infection as the primary endpoint. A common method of analysis for such trials is to compare the times to infection between the vaccine and placebo groups using a Cox regression model. With new technology, we can sometimes additionally record the precise number of virions that cause infection rather than just the indicator that infection occurred. In this article, we develop a unified approach for vaccine trials that couples the time to infection with the number of infecting or founder viruses. We assume that the instantaneous risk of a potentially infectious exposure for individuals in the placebo and vaccine groups follows the same proportional intensity model. Following exposure, the number of founder v

SUBMITTER: Follmann D 

PROVIDER: S-EPMC4729213 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature