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

المؤلف

Williamson, Diane

المصدر

Advances in Preventive Medicine

العدد

المجلد 2012، العدد 2012 (31 ديسمبر/كانون الأول 2012)، ص ص. 1-7، 7ص.

الناشر

Hindawi Publishing Corporation

تاريخ النشر

2011-09-29

دولة النشر

مصر

عدد الصفحات

7

التخصصات الرئيسية

الصحة العامة

الملخص 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.

نمط استشهاد جمعية علماء النفس الأمريكية (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

نمط استشهاد الجمعية الأمريكية للغات الحديثة (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

نمط استشهاد الجمعية الطبية الأمريكية (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

نوع البيانات

مقالات

لغة النص

الإنجليزية

الملاحظات

Includes bibliographical references

رقم السجل

BIM-466306