A Study to Evaluate the Immunogenicity, Safety and Tolerability of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult Participants

Phase 3 Completed 329 enrolled Crucell Holland BV

RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to compare the humoral immune response induced by 3 different batches of Ad26.ZEBOV as measured by enzyme - linked immunosorbent assay (ELISA) against the Ebola virus (EBOV) GP (Glycoprotein) at 56 days post prime.

Timeline

Start: 2015-09-21
Primary completion: 2016-01-22
Completion: 2016-07-20

Outcome

Missed primary endpoint

paper Study 2 demonstrated a dose-dependent response; however, non-inferiority against the full clinical dose was not met. PMID 34930928 ↗

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	Ad26.ZEBOV	Vaccine	5e+10 unknown	Intramuscular
Subject	MVA-BN-Filo	Vaccine	1e+08 unknown	Intramuscular

Indications

No indication recorded.