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Cardiac Safety of Modified Vaccinia Ankara for Vaccination against Smallpox in a Young, Healthy Study Population

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  • Eva-Maria Zitzmann-Roth
  • Frank von Sonnenburg
  • Stephan de la Motte
  • Nathaly Arndtz-Wiedemann
  • Alfred von Krempelhuber
  • Nadine Uebler
  • Jens Vollmar
  • Garth Virgin
  • Paul Chaplin

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. Trial Registration: ClinicalTrials.gov NCT00316524

Suggested Citation

  • Eva-Maria Zitzmann-Roth & Frank von Sonnenburg & Stephan de la Motte & Nathaly Arndtz-Wiedemann & Alfred von Krempelhuber & Nadine Uebler & Jens Vollmar & Garth Virgin & Paul Chaplin, 2015. "Cardiac Safety of Modified Vaccinia Ankara for Vaccination against Smallpox in a Young, Healthy Study Population," PLOS ONE, Public Library of Science, vol. 10(4), pages 1-14, April.
    • Handle: RePEc:plo:pone00:0122653
    DOI: 10.1371/journal.pone.0122653
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