A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis

Phase 2 Completed 632 enrolled Bavarian Nordic National Institute of Allergy and Infectious Diseases (NIAID) · collab

Non-randomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.

Timeline

Start: 2006-07
Primary completion: 2009-11
Completion: 2010-04

Outcome

Met primary endpoint

paper Seroconversion rates and geometric mean titers for total and neutralizing vaccinia-specific antibodies in the AD group were non-inferior compared to the healthy subjects. PMID 26439129 ↗

Publications

Results Greenberg RN, Hurley MY, Dinh DV, Mraz S, Vera JG, von Bredow D, von Krempelhuber A, Roesch S, Virgin G, Arndtz-Wiedemann N, Meyer TP, Schmidt D, Nichols R, Young P, Chaplin P. A Multicenter, Open-Label, Controlled Phase II Study to Evaluate Safety and Immunogenicity of MVA Smallpox Vaccine (IMVAMUNE) in 18-40 Year Old Subjects with Diagnosed Atopic Dermatitis. PLoS One. 2015 Oct 6;10(10):e0138348. doi: 10.1371/journal.pone.0138348. eCollection 2015.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IMVAMUNE	Vaccine	—	Subcutaneous