title: Cardiac safety of Modified Vaccinia Ankara for vaccination against smallpox in a young, healthy study population.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Vaccination with MVA was safe and well tolerated and did not increase the risk for development of myo-/pericarditis.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00316524.
authors: Praxis Zitzmann-Roth, München, Germany.
authors: Eva-Maria
authors: EM
authors: Zitzmann-Roth
authors: Department of Infectious Diseases and Tropical Medicine, Section of International Medicine and Public Health, Ludwig-Maximilians-Universität, Munich, Germany.
authors: Frank
authors: F
authors: von Sonnenburg
authors: Harrison Clinical Research GmbH, Munich, Germany.
authors: Stephan
authors: S
authors: de la Motte
authors: Bavarian Nordic GmbH, Martinsried, Germany.
authors: Nathaly
authors: N
authors: Arndtz-Wiedemann
authors: Bavarian Nordic GmbH, Martinsried, Germany.
authors: Alfred
authors: A
authors: von Krempelhuber
authors: Bavarian Nordic GmbH, Martinsried, Germany.
authors: Nadine
authors: N
authors: Uebler
authors: Bavarian Nordic GmbH, Martinsried, Germany.
authors: Jens
authors: J
authors: Vollmar
authors: Bavarian Nordic GmbH, Martinsried, Germany.
authors: Garth
authors: G
authors: Virgin
authors: Bavarian Nordic GmbH, Martinsried, Germany.
authors: Paul
authors: P
authors: Chaplin
mesh_terms: D000328:Adult; D005260:Female; D064368:Healthy Volunteers; D006321:Heart / Q000187:drug effects*; D006801:Humans; D008297:Male; D012900:Smallpox Vaccine / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D012900:Smallpox Vaccine