Elsevier

Tuberculosis

Volume 92, Supplement 1, March 2012, Pages S25-S29
Tuberculosis

Rational approach to selection and clinical development of TB vaccine candidates

https://doi.org/10.1016/S1472-9792(12)70009-4Get rights and content

Abstract

A rational process is clearly needed and can be extremely helpful for selection, assessing and advancing TB vaccine candidates from entry into preclinical and clinical development and for advancing candidates from early safety and immunogenicity clinical trials to proof-of-concept and pivotal efficacy trials. A joint effort between Aeras and the Tuberculosis Vaccine Initiative has focused on the development of objective criteria for a number of key general vaccine characteristics which can be assessed at critical stages of development. In order to maximize development efficiency, increase likelihood of success, and optimize use of scarce resources, this process includes establishment of gates for moving TB vaccine candidates through progressive development stages based on meeting the established criteria for specific vaccine candidates.

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Acknowledgements

We are grateful to Michael Brennan, Jelle Thole, Thomas Evans, Ann Ginsberg and Nariman Panahian for their helpful input and reviews of this report.

Conflicts of interest

The authors have no conflicts of interest to declare.

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