一项多中心、开放标签、对照的II期研究，旨在评估MVA天花疫苗（IMVAMUNE）在18至40岁诊断为特应性皮炎的受试者中的安全性和免疫原性。
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.
作者信息
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, Chaplin Paul
机构信息
University of Kentucky School of Medicine, Lexington, KY, United States of America.
Rx Clinical Research, Inc., Garden Grove, CA, United States of America.
出版信息
PLoS One. 2015 Oct 6;10(10):e0138348. doi: 10.1371/journal.pone.0138348. eCollection 2015.
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.
背景
天花疫苗的复制可能会在特应性皮炎（AD）患者中引发严重并发症。先前对改良痘苗病毒安卡拉株（MVA，一种在人体内不复制的疫苗）进行评估的研究表明，其在健康志愿者中具有良好的安全性和免疫原性。
目的
这项II期研究比较了纳入350名AD患者（SCORAD≤30）和282名健康受试者的MVA的安全性和免疫原性。
方法
受试者用MVA接种两次，每次剂量皮下注射，间隔4周。监测不良事件、心脏参数以及痘苗病毒体液免疫反应的发展情况。
结果
两组中疫苗的总体安全性相似。AD患者中影响皮肤的不良事件发生频率明显更高，但这些事件大多为轻度至中度。AD组中针对痘苗特异性抗体的总抗体和中和抗体的血清转化率及几何平均滴度与健康受试者相比并不逊色。
局限性
研究人群规模限制了对发生频率低于1%的严重不良事件的检测。
结论
MVA具有良好的安全性，并且能够在AD患者中引发痘苗特异性免疫反应。
试验注册
ClinicalTrials.gov NCT00316602。
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