Assessing vaccine effects in repeated low-dose challenge experiments.

Publication Type:

Journal Article

Source:

Biometrics, Volume 65, Issue 4, p.1223-32 (2009)

Keywords:

2009, AIDS Vaccines, Animals, Biometry, Center-Authored Paper, HIV, HIV Infections, Humans, Likelihood Functions, Macaca, Public Health Sciences Division, Simian Acquired Immunodeficiency Syndrome, Simian immunodeficiency virus, Statistics, Nonparametric, Survival Analysis, Time Factors, Vaccine and Infectious Disease Institute

Abstract:

Evaluation of HIV vaccine candidates in nonhuman primates (NHPs) is a critical step toward developing a successful vaccine to control the HIV pandemic. Historically, HIV vaccine regimens have been tested in NHPs by administering a single high dose of the challenge virus. More recently, evaluation of candidate HIV vaccines has entailed repeated low-dose challenges, which more closely mimic typical exposure in natural transmission settings. In this article, we consider evaluation of the type and magnitude of vaccine efficacy from such experiments. Based on the principal stratification framework, we also address evaluation of potential immunological surrogate endpoints for infection.