Safety, reactogenicity, and immunogenicity of a 2-dose Ebola vaccine regimen of Ad26.ZEBOV followed by MVA-BN-Filo in healthy adult pregnant women: study protocol for a phase 3 open-label randomized controlled trial

Safety, reactogenicity, and immunogenicity of a 2-dose Ebola vaccine regimen of Ad26.ZEBOV followed by MVA-BN-Filo in healthy adult pregnant women: study protocol for a phase 3 open-label randomized controlled trial

Abstract Background Risks to mother and fetus following Ebola virus infection are very high. Evaluation of safety and immunogenicity of non-replicating Ebola vaccine candidates is a priority for use in pregnant women. This is the protocol for a randomized, open-label, single-center phase 3 clinical...

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Bibliographic Details
Main Authors: Etienne Karita, Julien Nyombayire, Rosine Ingabire, Amelia Mazzei, Tyronza Sharkey, Jeannine Mukamuyango, Susan Allen, Amanda Tichacek, Rachel Parker, Frances Priddy, Felix Sayinzoga, Sabin Nsanzimana, Cynthia Robinson, Michael Katwere, Dickson Anumendem, Maarten Leyssen, Malinda Schaefer, Kristin M. Wall
Format: Article
Language:English
Published: BMC 2022-06-01
Series:Trials
Subjects:
Ebola virus
Vaccine safety
Reactogenicity
Immunogenicity
Pregnancy
Online Access:https://doi.org/10.1186/s13063-022-06360-3

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