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Publications / Qin 2007 (J Infect Dis)

Overview

Publication

J Infect Dis. 2007 Nov 1; 196(9):1304-12.

PubMed ID: 17922394

Title

A framework for assessing immunological correlates of protection in vaccine trials

Authors

Qin L, Gilbert PB, Corey L, McElrath MJ, Self SG

Abstract

A central goal of vaccine research is to identify a vaccine-induced immune response that predicts protection from infection or disease. The term ""correlate of protection"" has been used to refer to at least 3 distinct concepts, which has resulted in confusion surrounding this topic. We propose precise definitions of these different concepts of immune correlates, using the nomenclature ""correlate of risk,"" ""level 1 surrogate of protection,"" and ""level 2 surrogate of protection."" We suggest a general framework for assessing these 3 levels of immune correlates in vaccine efficacy trials. To demonstrate the proposed principles, we analyze data from a 1943 influenza vaccine field trial, supporting Weiss strain A-specific antibody titers as a level 1 surrogate of protection. Other real and simulated examples are also discussed.

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