Assessment of Myocarditis After Replication-Deficient Smallpox Immunization
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorWomack Army Medical Center
About this trial
This is a prospective observational phase IV study of a novel, replication-deficient smallpox vaccine that has been recently been approved by FDA. The purpose of this study is to determine if there are any abnormalities detected by electrocardiographic testing and/or blood tests within 35 days of receiving the second dose of smallpox vaccine either alone or co-administered with other vaccines that may/may not be suggestive of myopericarditis.
Eligibility criteria
Qualifiers
Active duty military personnel within the range of 18-45 years of age without limitations to gender or ethnicity.
Primary vaccinee (receiving smallpox vaccine for the first time) with a force health protection requirement for the smallpox vaccination
Medical screening for immunization completed and potential participant found eligible for immunization (standard of care)
Disqualifiers
Known contraindication to replication deficient smallpox vaccination based on FDA-approved package insert for JYNNEOS™ vaccine.
No indication for replication deficient smallpox vaccination based on FDA-approved package insert for JYNNEOS, ACIP or DoD guidelines
Secondary smallpox vaccinee (patients who had previously received any smallpox vaccine).
Age less than 18 years or age greater than 45 years.
Trial design
Treatments tested in this trial
- JYNNEOS
Treatment groups
2,350 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Womack Army Medical Center
Lead sponsor
United States Naval Medical Center, San Diego
Collaborator
C.R.Darnall Army Medical Center
Collaborator
Source ClinicalTrials.gov