Cardiac Safety of Modified Vaccinia Ankara for Vaccination against Smallpox in a Young,Healthy Study Population |
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Authors: | 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 |
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Institution: | 1. Praxis Zitzmann-Roth, München, Germany.; 2. Department of Infectious Diseases and Tropical Medicine, Section of International Medicine and Public Health, Ludwig-Maximilians-Universität, Munich, Germany.; 3. Harrison Clinical Research GmbH, Munich, Germany.; 4. Bavarian Nordic GmbH, Martinsried, Germany.; Universidad de Valladolid, SPAIN, |
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Abstract: | BackgroundConventional 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.MethodsCardiac 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.ResultsA 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.ConclusionsVaccination with MVA was safe and well tolerated and did not increase the risk for development of myo-/pericarditis.Trial RegistrationClinicalTrials.gov NCT00316524 |
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