A Framework for Assessing Immunological Correlates of Protection in Vaccine Trials

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 prop...

Full description

Saved in:
Bibliographic Details
Published in:The Journal of infectious diseases 2007-11, Vol.196 (9), p.1304-1312
Main Authors: Qin, Li, Gilbert, Peter B., Corey, Lawrence, McElrath, M. Juliana, Self, Steven G.
Format: Article
Language:English
Subjects:
AIDS vaccines
Antibodies
Antibodies - blood
Antibody Formation
Biological markers
Biomarkers
Clinical trials
Clinical Trials as Topic
Control groups
Experimentation
Humans
Immune response
Immunization
Immunology
Infections
Vaccination
Vaccines - immunology
Viruses
Citations: Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:0022-1899
1537-6613
DOI:10.1086/522428