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Surrogates of protection in repeated low‐dose challenge experiments
Author(s) -
Long Dustin M.,
Hudgens Michael G.,
Wu ChihDa
Publication year - 2015
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.6436
Subject(s) - simian immunodeficiency virus , human immunodeficiency virus (hiv) , vaccination , immunology , medicine , clinical endpoint , pandemic , surrogate endpoint , virus , vaccine trial , covid-19 , virology , clinical trial , disease , pathology , infectious disease (medical specialty)
A critical step toward developing a successful vaccine to control the human immunodeficiency virus pandemic entails evaluation of vaccine candidates in non‐human primates (NHPs). Historically, these studies have usually entailed challenges (i.e., exposures) with very high doses of a simian version of human immunodeficiency virus, resulting in infection of all NHPs in the experiment after a single challenge. More recently, researchers have begun to conduct repeated low‐dose challenge (RLC) studies in NHPs that are believed to more closely mimic typical exposure in natural human transmission settings. One objective of RLC studies is to assess whether measured immune responses to vaccination can serve as surrogate endpoints for the primary endpoint of interest, namely infection. In this paper, different designs of RLC studies for assessing a binary surrogate of protection are considered. Copyright © 2015 John Wiley & Sons, Ltd.