Pivotal Shigella Vaccine Efficacy Trials-Study Design Considerations from a Vaccine Trial Design Working Group.
Author
Pavlinac, Patricia BRogawski McQuade, Elizabeth T
Platts-Mills, James A
Kotloff, Karen L
Deal, Carolyn
Giersing, Birgitte K
Isbrucker, Richard A
Kang, Gagandeep
Ma, Lyou-Fu
MacLennan, Calman A
Patriarca, Peter
Steele, Duncan
Vannice, Kirsten S
Date
2022-03-22Journal
VaccinesPublisher
MDPI AGType
Article
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Vaccine candidates for Shigella are approaching phase 3 clinical trials in the target population of young children living in low- and middle-income countries. Key study design decisions will need to be made to maximize the success of such trials and minimize the time to licensure and implementation. We convened an ad hoc working group to identify the key aspects of trial design that would meet the regulatory requirements to achieve the desired indication of prevention of moderate or severe shigellosis due to strains included in the vaccine. The proposed primary endpoint of pivotal Shigella vaccine trials is the efficacy of the vaccine against the first episode of acute moderate or severe diarrhea caused by the Shigella strains contained within the vaccine. Moderate or severe shigellosis could be defined by a modified Vesikari score with dysentery and molecular detection of vaccine-preventable Shigella strains. This report summarizes the rationale and current data behind these considerations, which will evolve as new data become available and after further review and consultation by global regulators and policymakers.Identifier to cite or link to this item
http://hdl.handle.net/10713/18661ae974a485f413a2113503eed53cd6c53
10.3390/vaccines10040489
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