A Study of a 2-dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed by MVA-BN-Filo in Healthy Pregnant Women

Summary

The purpose of this study is: a) to assess adverse maternal/fetal outcomes in pregnant women randomized to receive the 2- dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo \[Group A\]) and in control women (unvaccinated pregnant women \[Group B\]); and b) to assess adverse neonatal/infant outcomes in neonates/infants born to women randomized to receive the 2-dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo \[Group A\]) and in neonates/infants born to control women (unvaccinated during pregnancy \[Group B\]).

Timeline

Start

2020-10-05

Primary completion

2023-03-02

Completion

2023-03-02

Publications

• Nyombayire J, Ingabire R, Mazzei A, Sharkey T, Umuhoza C, Mukamuyango J, Allen S, Tichacek A, Parker R, Wall KM, Katwere M, Keshinro B, Gaddah A, Wang Y, Forcheh CA, McLean C, Oriol-Mathieu V, Luhn K, Robinson C, Karita E. Heterologous two-dose Ebola vaccine regimen in pregnant women in Rwanda: a randomized controlled phase 3 trial. Nat Med. 2025 Nov;31(11):3899-3906. doi: 10.1038/s41591-025-03932-z. Epub 2025 Sep 8.
• Karita E, Nyombayire J, Ingabire R, Mazzei A, Sharkey T, Mukamuyango J, Allen S, Tichacek A, Parker R, Priddy F, Sayinzoga F, Nsanzimana S, Robinson C, Katwere M, Anumendem D, Leyssen M, Schaefer M, Wall KM. 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. Trials. 2022 Jun 20;23(1):513. doi: 10.1186/s13063-022-06360-3.

Drugs

Indications

No indication recorded.