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

作者：Greenberg Richard N^*; Hurley 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; Chaplin Paul

来源：PLos One, 2015, 10(10): e0138348.

DOI：10.1371/journal.pone.0138348

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.

• 出版日期2015-10-6