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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00316524.

• 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
• Journal: PloS one (PLoS One) Vol. 10 Issue 4 Pg. e0122653 ( 2015) ISSN: 1932-6203 [Electronic] United States
• PMID: 25879867 (Publication Type: Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Smallpox Vaccine

Topics

• Adult
• Female
• Healthy Volunteers
• Heart (drug effects)
• Humans
• Male
• Smallpox Vaccine (administration & dosage, adverse effects)