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- Title
Reply to McShane.
- Authors
Hill, Philip C; Cobelens, Frank; Martinez, Leonardo; Garcia-Basteiro, Alberto L; Behr, Marcel A; Rangaka, Molebogeng X; Churchyard, Gavin; Evans, Tom; Hanekom, Willem; White, Richard G
- Abstract
This document is a reply to a commentary by Professor Helen McShane regarding a recent perspective on shortening phase 3 tuberculosis vaccine trials. The authors argue that more creative and efficient trial designs should be considered in vaccine development, and that engagement with regulators is crucial. They also discuss the importance of balancing safety evaluations and efficacy measurements in vaccine trials, suggesting that safety follow-up should have its own independent sample size requirements. The authors thank Professor McShane and the journal for stimulating discussions on strategies for developing a more effective tuberculosis vaccine in a shorter amount of time.
- Subjects
HERPES zoster vaccines; TUBERCULOSIS vaccines; VACCINE trials
- Publication
Journal of Infectious Diseases, 2024, Vol 229, Issue 2, p616
- ISSN
0022-1899
- Publication type
Article
- DOI
10.1093/infdis/jiad466