A Study to Evaluate Safety, Tolerability, and Immunogenicity of Heterologous Prime-boost Regimens Using the Multivalent Filovirus Vaccines Ad26.Filo and MVA-BN-Filo Administered in Different Sequences and Schedules in Healthy Adults

Phase 1 Completed 72 enrolled Janssen Vaccines & Prevention B.V. National Institute of Allergy and Infectious Diseases (NIAID) · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.Filo as heterologous prime-boost vaccine regimens in healthy adult participants.

Timeline

Start: 2016-08
Primary completion: 2017-05
Completion: 2018-01

Publications

Bockstal V, Shukarev G, McLean C, Goldstein N, Bart S, Gaddah A, Anumenden D, Stoop JN, Marit de Groot A, Pau MG, Hendriks J, De Rosa SC, Cohen KW, McElrath MJ, Callendret B, Luhn K, Douoguih M, Robinson C. First-in-human study to evaluate safety, tolerability, and immunogenicity of heterologous regimens using the multivalent filovirus vaccines Ad26.Filo and MVA-BN-Filo administered in different sequences and schedules: A randomized, controlled study. PLoS One. 2022 Oct 5;17(10):e0274906. doi: 10.1371/journal.pone.0274906. eCollection 2022.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ADENOVIRUS TYPE 26 ENCODING EBOLA VIRUS GLYCOPROTEIN	Vaccine	5e+10 vg	Intramuscular
Subject	Ad26.Filo	Vaccine	9e+10 vg	Intramuscular
Subject	MVA-BN-Filo	Vaccine	1e+08 unknown	Intramuscular
Subject	MVA-BN-Filo	Vaccine	5e+08 unknown	Intramuscular

Indications

No indication recorded.