The Role of Immune Correlates and Surrogate Markers in the Development of Vaccines and Immunotherapies for Plague
Author
Source
Advances in Preventive Medicine
Issue
Vol. 2012, Issue 2012 (31 Dec. 2012), pp.1-7, 7 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2011-09-29
Country of Publication
Egypt
No. of Pages
7
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Williamson, Diane. 2011. The Role of Immune Correlates and Surrogate Markers in the Development of Vaccines and Immunotherapies for Plague. Advances in Preventive Medicine،Vol. 2012, no. 2012, pp.1-7.
https://search.emarefa.net/detail/BIM-466306
Modern Language Association (MLA)
Williamson, Diane. The Role of Immune Correlates and Surrogate Markers in the Development of Vaccines and Immunotherapies for Plague. Advances in Preventive Medicine No. 2012 (2012), pp.1-7.
https://search.emarefa.net/detail/BIM-466306
American Medical Association (AMA)
Williamson, Diane. The Role of Immune Correlates and Surrogate Markers in the Development of Vaccines and Immunotherapies for Plague. Advances in Preventive Medicine. 2011. Vol. 2012, no. 2012, pp.1-7.
https://search.emarefa.net/detail/BIM-466306
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-466306