A Non-inferiority Trial to Compare MVA-BN® Smallpox Vaccine to ACAM2000®

Summary

To demonstrate the efficacy of MVA-BN® in terms of vaccinia-specific Plaque Reduction Neutralization Test (PRNT) antibody response and by showing that vaccination prior to administration of ACAM2000® results in an attenuated take.

Timeline

Start

2015-03

Primary completion

2017-03

Completion

2017-08

Outcome

Met primary endpoint

registry analysis (non-inferiority test); Group 1 vs Group 2; GMT Ratio (Group 1 / Group 2) 1.935 (95% CI 1.562 to 2.397) NCT01913353 ↗

registry analysis (superiority test); Group 1 vs Group 2; Area attenuation ratio (AAR) 97.9 (95% CI 96.6 to 98.3) NCT01913353 ↗

paper The median lesion areas of the major cutaneous reaction were 0 mm2 in the MVA group and 76.0 mm2 in the ACAM2000-only group PMID 31722150 ↗

paper resulting in an area attenuation ratio of 97.9% (95% CI, 96.6 to 98.3). PMID 31722150 ↗

release “The study achieved both of its primary endpoints, demonstrating IMVAMUNE’s efficacy in comparison to ACAM2000 ® , the current U.S. licensed replicating smallpox vaccine.” bavarian-nordic.com ↗

release “The study achieved both of its primary endpoints, demonstrating IMVAMUNE’s efficacy in comparison to ACAM2000 ®” bavarian-nordic.com ↗

release “Disclosed positive Phase 3 efficacy data for the IMVAMUNE ® smallpox vaccine in comparison to ACAM2000” bavarian-nordic.com ↗

release “the latter of which showed non-inferiority of MVA-BN compared to ACAM2000” bavarian-nordic.com ↗

Publications

• Pittman PR, Hahn M, Lee HS, Koca C, Samy N, Schmidt D, Hornung J, Weidenthaler H, Heery CR, Meyer TPH, Silbernagl G, Maclennan J, Chaplin P. Phase 3 Efficacy Trial of Modified Vaccinia Ankara as a Vaccine against Smallpox. N Engl J Med. 2019 Nov 14;381(20):1897-1908. doi: 10.1056/NEJMoa1817307.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ACAM2000	Vaccine	0.0025 ml	Other
Subject	IMVAMUNE	Vaccine	0.5 ml	Subcutaneous

Indications

No indication recorded.