Dataset Information

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.

SUBMITTER: Zitzmann-Roth EM

PROVIDER: S-EPMC4399887 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Publications

Cardiac safety of Modified Vaccinia Ankara for vaccination against smallpox in a young, healthy study population.

Zitzmann-Roth Eva-Maria EM von Sonnenburg Frank F de la Motte Stephan S Arndtz-Wiedemann Nathaly N von Krempelhuber Alfred A Uebler Nadine N Vollmar Jens J Virgin Garth G Chaplin Paul P

PloS one 20150416 4

<h4>Background</h4>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.<h4>Methods</h4>Cardiac safety of one and two doses of MVA compared to placebo was ass ...[more]

PMID: 25879867

Similar Datasets

Project description:BackgroundVaccinia-associated myo/pericarditis was observed during the US smallpox vaccination (DryVax) campaign initiated in 2002. A highly-attenuated vaccinia strain, modified vaccinia Ankara (MVA) has been evaluated in clinical trials as a safer alternative to DryVax and as a vector for recombinant vaccines. Due to the lack of prospectively collected cardiac safety data, the US Food and Drug Administration required cardiac screening and surveillance in all clinical trials of MVA since 2004. Here, we report cardiac safety surveillance from 6 phase I trials of MVA vaccines.MethodsFour clinical research organizations contributed cardiac safety data using common surveillance methods in trials administering MVA or recombinant MVA vaccines to healthy participants. 'Routine cardiac investigations' (ECGs and cardiac enzymes obtained 2 weeks after injections of MVA or MVA-HIV recombinants, or placebo-controls), and 'Symptom-driven cardiac investigations' are reported. The outcome measure is the number of participants who met the CDC-case definition for vaccinia-related myo/pericarditis or who experienced cardiac adverse events from an MVA vaccine.ResultsFour hundred twenty-five study participants had post-vaccination safety data analyzed, 382 received at least one MVA-containing vaccine and 43 received placebo; 717 routine ECGs and 930 cardiac troponin assays were performed. Forty-five MVA recipients (12%) had additional cardiac testing performed; 22 for cardiac symptoms, 19 for ECG/laboratory changes, and 4 for cardiac symptoms with an ECG/laboratory change. No participant had evidence of symptomatic or asymptomatic myo/pericarditis meeting the CDC-case definition and judged to be related to an MVA vaccine.ConclusionsProspective surveillance of MVA recipients for myo/pericarditis did not detect cardiac adverse reactions in 382 study participants.Trial registrationClinicalTrials.gov NCT00082446?NCT003766090?NCT00252148?NCT00083603?NCT00301184?NCT00428337.

Dataset Information

Cardiac safety of Modified Vaccinia Ankara for vaccination against smallpox in a young, healthy study population.

Background

Methods

Results

Conclusions

Trial registration

Publications

Cardiac safety of Modified Vaccinia Ankara for vaccination against smallpox in a young, healthy study population.

Similar Datasets

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