A Study to Evaluate A Range of Dose Levels of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult Participants

Phase 3 Completed 525 enrolled Janssen Vaccines & Prevention B.V.

RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to demonstrate the non-inferiority of a heterologous prime-boost regimen using Ad26.ZEBOV as prime and MVA-BN-Filo as boost administered at different doses at a 56-day interval versus the same regimen with the recently released batches of Ad26.ZEBOV and MVA-BN-Filo in terms of humoral immune response against the Ebola virus (EBOV) GP (glycoprotein) as measured by enzyme-linked immunosorbent assay (ELISA) at 21 days post boost.

Timeline

Start: 2015-09-21
Primary completion: 2016-06-07
Completion: 2016-11-29

Publications

Bockstal V, Gaddah A, Goldstein N, Shukarev G, Bart S, Luhn K, Robinson C, Anumendem D, Leyssen M, Douoguih M. Assessments of different batches and dose levels of a two-dose Ad26.ZEBOV and MVA-BN-Filo vaccine regimen. NPJ Vaccines. 2021 Dec 20;6(1):157. doi: 10.1038/s41541-021-00402-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ADENOVIRUS TYPE 26 ENCODING EBOLA VIRUS GLYCOPROTEIN	Vaccine	8e+09 unknown	Intramuscular
Subject	ADENOVIRUS TYPE 26 ENCODING EBOLA VIRUS GLYCOPROTEIN	Vaccine	2e+10 unknown	Intramuscular
Subject	ADENOVIRUS TYPE 26 ENCODING EBOLA VIRUS GLYCOPROTEIN	Vaccine	5e+10 unknown	Intramuscular
Subject	MVA-BN-Filo	Vaccine	5e+07 unknown	Intramuscular
Subject	MVA-BN-Filo	Vaccine	1e+08 unknown	Intramuscular

Indications

No indication recorded.