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

Authors

Richard N. Greenberg, University of KentuckyFollow
Maria Yadira Hurley, Saint Louis University
Dinh V. Dinh, Rx Clinical Research, Inc.
Serena Mraz, Vallejo Dermatology Office
Javier Gomez Vera, ISSSTE, Mexico
Dorothea von Bredow, Bavarian Nordic GmbH, Germany
Alfred von Krempelhuber, Bavarian Nordic GmbH, Germany
Siegfried Roesch, Bavarian Nordic GmbH, Germany
Garth Virgin, Bavarian Nordic GmbH, Germany
Nathaly Arndtz-Wiedemann, Bavarian Nordic GmbH, Germany
Thomas Peter Meyer, Bavarian Nordic GmbH, Germany
Darja Schmidt, Bavarian Nordic GmbH, Germany
Richard Nichols, Bavarian Nordic GmbH, Germany
Philip Young, Bavarian Nordic GmbH, Germany
Paul Chaplin, Bavarian Nordic GmbH, Germany

Abstract

BACKGROUND: Replicating smallpox vaccines can cause severe complications in individuals with atopic dermatitis (AD). Prior studies evaluating Modified Vaccinia Ankara virus (MVA), a non-replicating vaccine in humans, showed a favorable safety and immunogenicity profile in healthy volunteers.

OBJECTIVE: This Phase II study compared the safety and immunogenicity of MVA enrolling groups of 350 subjects with AD (SCORAD ≤ 30) and 282 healthy subjects.

METHODS: Subjects were vaccinated twice with MVA, each dose given subcutaneously 4 weeks apart. Adverse events, cardiac parameters, and the development of vaccinia virus humoral immune responses were monitored.

RESULTS: The overall safety of the vaccine was similar in both groups. Adverse events affecting skin were experienced significantly more often in subjects with AD, but the majority of these events were mild to moderate in intensity. 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.

LIMITATIONS: The size of the study population limited the detection of serious adverse events occurring at a frequency less than 1%.

CONCLUSION: MVA has a favorable safety profile and the ability to elicit vaccinia-specific immune responses in subjects with AD.

TRIAL REGISTRATION: ClinicalTrials.gov NCT00316602.

Document Type

Article

Publication Date

10-6-2015

Notes/Citation Information

Published in PLOS One, v. 10, no. 10, article e0138348, p. 1-19.

The publisher issued a correction on November 10, 2015: "The second author’s name is spelled incorrectly. The correct name is: Maria Yadira Hurley."

© 2015 Greenberg et al.

This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited

Digital Object Identifier (DOI)

http://dx.doi.org/10.1371/journal.pone.0138348

Funding Information

The study was funded by Bavarian Nordic through NIAID contract #N01-AI-40072 (http://www.niaid.nih.gov/Pages/default.aspx), and The National Institute of Allergy and Infectious Diseases (NIAID). These funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. Bavarian Nordic provided grants to Rx Clinical Research, Inc. Rx Clinical Research, Inc. provided support in the form of salary for author DVD but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific role of this author is articulated in the ‘author contributions’ section. Bavarian Nordic provided support in the form of salaries for several authors (DB, AK, SR, GV, NA, TM, DS, RN, PY and PC), but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.

Related Content

Greenberg R.N., Hurley M.Y., Dinh D.V., Mraz S., Vera J.G., von Bredow D., et al. (2015). Correction: 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 10:11, e0142802. doi: http://dx.doi.org/10.1371/journal.pone.0142802

Repository Citation

Greenberg, Richard N.; Hurley, Maria Yadira; Dinh, Dinh V.; Mraz, Serena; Vera, Javier Gomez; von Bredow, Dorothea; von Krempelhuber, Alfred; Roesch, Siegfried; Virgin, Garth; Arndtz-Wiedemann, Nathaly; Meyer, Thomas Peter; Schmidt, Darja; Nichols, Richard; Young, Philip; and Chaplin, Paul, "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" (2015). Internal Medicine Faculty Publications. 84.
https://uknowledge.uky.edu/internalmedicine_facpub/84