A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects

Phase 3 Completed 4005 enrolled Bavarian Nordic

RandomizedParallel-groupQuadruple-blindPrevention

Summary

A randomized, double-blind, placebo-controlled Phase III trial to evaluate immunogenicity and safety of three consecutive production lots of IMVAMUNE® (MVA-BN®) smallpox vaccine in healthy, vaccinia-naïve subjects.

Timeline

Start: 2013-02
Primary completion: 2013-11
Completion: 2014-06

Outcome

Met primary endpoint

paper The three MVA lots induced equivalent antibody titers two weeks after the second vaccination PMID 29652929 ↗

release “The three lots of MVA-BN induced equivalent antibody responses, meeting the primary endpoint of the study” bavarian-nordic.com ↗

Publications

Overton ET, Lawrence SJ, Wagner E, Nopora K, Rosch S, Young P, Schmidt D, Kreusel C, De Carli S, Meyer TP, Weidenthaler H, Samy N, Chaplin P. Immunogenicity and safety of three consecutive production lots of the non replicating smallpox vaccine MVA: A randomised, double blind, placebo controlled phase III trial. PLoS One. 2018 Apr 13;13(4):e0195897. doi: 10.1371/journal.pone.0195897. eCollection 2018.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IMVAMUNE	Vaccine	0.5 ml	—