HOMEPRODUCTSSERVICESCOMPANYCONTACTFAQResearchDictionaryPharmaMobileSign Up FREE or Login

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.

AbstractBACKGROUND:
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.
AuthorsRichard N Greenberg, 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
JournalPloS one (PLoS One) Vol. 10 Issue 10 Pg. e0138348 ( 2015) ISSN: 1932-6203 [Electronic] United States
PMID26439129 (Publication Type: Journal Article, Research Support, N.I.H., Extramural)

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research network!


Choose Username:
Email:
Password:
Verify Password: