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Advances in Preventive Medicine
Volume 2012, Article ID 365980, 7 pages
http://dx.doi.org/10.1155/2012/365980
Review Article

The Role of Immune Correlates and Surrogate Markers in the Development of Vaccines and Immunotherapies for Plague

Biomedical Sciences Department, Defence Science & Technology Laboratory, Porton Down, Salisbury Wilts SP4 0JQ, UK

Received 7 June 2011; Accepted 8 August 2011

Academic Editor: Phillip R. Pittman

Copyright © 2012 E. D. Williamson. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

One of the difficulties in developing countermeasures to biothreat agents is the challenge inherent in demonstrating their efficacy in man. Since the first publication of the Animal Rule by the FDA, there has been increased discussion of potential correlates of protection in animal models and their use to establish surrogate markers of efficacy in man. The latter need to be relatively easy to measure in assays that are at least qualified, if not validated, in order to derive a quantitative assessment of the clinical benefit conferred. The demonstration of safety and clinical benefit is essential to achieve regulatory approval for countermeasures for which clinical efficacy cannot be tested directly, as is the case for example, for biodefence vaccines. Plague is an ancient, serious infectious disease which is still endemic in regions of the modern world and is a potential biothreat agent. This paper discusses potential immune correlates of protection for plague, from which it may be possible to derive surrogate markers of efficacy, in order to predict the clinical efficacy of candidate prophylaxes and therapies.