drugset / Trial / NCT04228783

A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants

NCT04228783

Phase 3 Completed 974 enrolled Janssen Vaccines & Prevention B.V.
RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to demonstrate that the paired 2-dose vaccine regimens from 3 consecutively manufactured lots of Adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 and 3 consecutively manufactured lots of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) including the ebola virus mayinga glycoprotein as Dose 2, administered at a 56-day interval, induce an equivalent humoral immune response.

Timeline

Start
2020-02-18
Primary completion
2022-04-25
Completion
2022-04-25

Drugs

EvaluationDrugModalityDoseRoute
Subject ADENOVIRUS TYPE 26 ENCODING EBOLA VIRUS GLYCOPROTEIN Vaccine 5e+10 unknown Intramuscular
Subject MVA-BN-Filo Vaccine 1e+08 unknown Intramuscular