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.

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.

• Authors: Richard N Greenberg, Maria Yadira Hurley, Yadira Hurley, Dinh V Dinh, Serena Mraz, Javier Gomez Vera, Dorothea von Bredow, Alfred von Krempelhuber, Siegfried Roesch, Garth Virgin, Nathaly Arndtz-Wiedemann, Thomas Peter Meyer, Darja Schmidt, Richard Nichols, Philip Young, Paul Chaplin
• Journal: PloS one (PLoS One) Vol. 10 Issue 10 Pg. e0138348 ( 2015) ISSN: 1932-6203 [Electronic] United States
• PMID: 26439129 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural)

Chemical References

• Smallpox Vaccine
• Viral Vaccines

Topics

• Adolescent
• Adult
• Antibody Formation (immunology)
• Dermatitis, Atopic (immunology, prevention & control)
• Humans
• Smallpox Vaccine (adverse effects, standards, therapeutic use)
• Vaccination
• Vaccinia virus (immunology)
• Viral Vaccines (adverse effects, standards, therapeutic use)
• Young Adult