Putative correlates of protection against shigellosis assessing immunomarkers across responses to S. sonnei investigational vaccine.

"Competing interests V.C., O.R., F.Ma., U.N., E.S., A.C., P.F., A.A., A.K.A., E.M., F.N., L.B.M., A.P., and F.Mi. are or were GSK employees when the study was designed, initiated, and/or conducted. V.C., O.R., A.K.A., F.N., and F.Mi. hold shares in GSK. L.B.M. reports paid travel costs by BMGF to attend Shigella meetings in January 2020. P.F. reports grants/contracts to GSK from BMGF. L.B.M. and F.Mi. report funding to GSK from BMGF for vaccine manufacturing and testing and patent issued on the 4-component Shigella GMMA formulation. K.A.C., R.W.F., and R.W.K. have no financial relationships to disclose. The authors declare no other financial and non-financial relationships and activities or conflicts of interest."

"The authors thank the study participants and site staff involved in the study, as well as the CCHMC study team and the Shigella project team at GVGH. The authors would like to acknowledge Brielle Barnard (WRAIR) for significant involvement in the collection of α4β7 data, Monica McNeil and Michelle Dickey (CCHMC) for overseeing laboratory and clinical operations, respectively, and Kishor Mariyala, Sateesh Aravapalli, and Rob Mulder (GSK) for providing statistical programming activities. The authors would also like to thank Akkodis Belgium c/o GSK for medical writing and design support (Petronela M. Petrar) and manuscript coordination. This study was funded by the Bill and Melinda Gates Foundation (BMFG) and GlaxoSmithKline Biologicals SA (study sponsor). GlaxoSmithKline Biologicals SA also covered all costs associated with the development of this manuscript."

"The study was conducted in accordance with all applicable regulatory requirements, the Good Clinical Practice guidelines, and the Declaration of Helsinki. The protocol and study-related documents were approved by the CCHMC institutional review board, and all participants provided written informed consent. The trial is registered on ClinicalTrials.gov (NCT03527173), and the full study protocol is available at www.gsk-studyregister.com (study ID 205626)."