Zitzmann-Roth Eva-Maria, von Sonnenburg Frank, de la Motte Stephan, Arndtz-Wiedemann Nathaly, von Krempelhuber Alfred, Uebler Nadine, Vollmar Jens, Virgin Garth, Chaplin Paul
Praxis Zitzmann-Roth, München, Germany.
Department of Infectious Diseases and Tropical Medicine, Section of International Medicine and Public Health, Ludwig-Maximilians-Universität, Munich, Germany.
PLoS One. 2015 Apr 16;10(4):e0122653. doi: 10.1371/journal.pone.0122653. eCollection 2015.
Conventional smallpox vaccines based on replicating vaccinia virus (VV) strains (e.g. Lister Elstree, NYCBOH) are associated with a high incidence of myo-/pericarditis, a severe inflammatory cardiac complication. A new smallpox vaccine candidate based on a non-replicating Modified Vaccinia Ankara (MVA) poxvirus has been assessed for cardiac safety in a large placebo-controlled clinical trial.
Cardiac safety of one and two doses of MVA compared to placebo was assessed in 745 healthy subjects. Vaccinia-naïve subjects received either one dose of MVA and one dose of placebo, two doses of MVA, or two doses of placebo by subcutaneous injection four weeks apart; vaccinia-experienced subjects received a single dose of MVA. Solicited and unsolicited adverse events (AE) and cardiac safety parameters (recorded as Adverse Events of Special Interest, AESI) were monitored after each injection.
A total of 5 possibly related AESI (3 cases of palpitations, 2 of tachycardia) were reported during the study. No case of myo- or pericarditis occurred. One possibly related serious AE (SAE) was reported during the 6-month follow-up period (sarcoidosis). The most frequently observed AEs were injection site reactions.
Vaccination with MVA was safe and well tolerated and did not increase the risk for development of myo-/pericarditis.
ClinicalTrials.gov NCT00316524.
基于复制性痘苗病毒（VV）株（如李斯特埃尔斯特里株、纽约市卫生局株）的传统天花疫苗与肌炎/心包炎的高发病率相关，肌炎/心包炎是一种严重的炎症性心脏并发症。一种基于非复制性安卡拉改良痘苗病毒（MVA）的新型天花疫苗候选物已在一项大型安慰剂对照临床试验中评估了其心脏安全性。
在745名健康受试者中评估了一剂和两剂MVA与安慰剂相比的心脏安全性。未接种过痘苗的受试者皮下注射一剂MVA和一剂安慰剂、两剂MVA或两剂安慰剂，间隔四周；有痘苗接种史的受试者接受一剂MVA。每次注射后监测主动和被动不良事件（AE）以及心脏安全参数（记录为特别关注的不良事件，AESI）。
研究期间共报告了5例可能相关的AESI（3例心悸，2例心动过速）。未发生肌炎或心包炎病例。在6个月的随访期内报告了1例可能相关的严重不良事件（SAE）（结节病）。最常观察到的AE是注射部位反应。
接种MVA是安全的，耐受性良好，不会增加发生肌炎/心包炎的风险。
ClinicalTrials.gov NCT00316524。
