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
This trial accepts healthy volunteersQualifiers
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 population
2350 Active duty military personnel age 18 to 45 years meeting the eligibility criteria and having a current force health protection requirement for the smallpox vaccination.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
JYNNEOS
Biological/Vaccinesmallpox vaccine
Treatment groups
2,350 Participants
are divided into 3 treatment groupsGroup A: Jynneos vaccine with out other vaccines1 intervention
Group B: Jynneos vaccine with other vaccines at dose 11 intervention
Group C: Jynneos vaccine with other vaccines at dose 21 intervention
Trial outcomes
Primary outcomes
1
Primary Objective
Determine the number of participants with myocarditis or pericarditis defined by abnormal laboratory biomarkers (hsTn) or abnormal ECG that may or may not be accompanied by subjective reports of chest, back, shoulder or upper abdominal pain or discomfort following receipt of the 2-dose series of a novel, replication-deficient (Jynneos™) smallpox vaccination in a group of adult primary smallpox vaccines.
Time frame
Within 35 days following the 2-dose series of a novel, replication-deficient (JYNNEOS™) smallpox vaccine2
Primary Outcome
Determine the number of participants with myocarditis or pericarditis defined by abnormal laboratory biomarkers (hsTn) or abnormal ECG that may or may not be accompanied by subjective reports of chest, back, shoulder or upper abdominal pain or discomfort following receipt of the 2-dose series of a novel, replication-deficient (Jynneos™) smallpox vaccination with co-receipt of any other ACIP recommended vaccine in a group of adult primary smallpox vaccines.
Time frame
Within 35 days following the 2-dose series of a novel, replication-deficient (JYNNEOS™) smallpox vaccineSecondary outcomes
1
Secondary Objective
Compare the difference in prospective incidence of symptomatic or asymptomatic myopericarditis when the first dose of Jynneos™ smallpox vaccination is administered concomitantly with other required vaccines versus when the first dose of Jynneos is administered in isolation from other required vaccines by at least 28 days.
Time frame
Within 35 days following the 2-dose series of a novel, replication-deficient (JYNNEOS™) smallpox vaccine2
Tertiary Objective
Determine the number of participants with changes in hsCRP and/or CPK and compare to hsTn, abnormal ECG changes and subjective reports of chest, back, shoulder or upper abdominal pain or discomfort following receipt of the 2-dose series of a novel, replication-deficient (Jynneos™) smallpox vaccination in a group of adult primary smallpox vaccines.
Time frame
Within 35 days following the 2-dose series of a novel, replication-deficient (JYNNEOS™) smallpox vaccine3
Quaternary Objective
Measure the presence or absence of any late gadolium enhancement, and ejection fraction on cardiac MRI among participants who demonstrate abnormal laboratory biomarkers (hsTn) or abnormal ECG in the absence of subjective reports of chest, back, shoulder or upper abdominal pain or discomfort following receipt of the 2-dose series of a novel, replication-deficient (Jynneos™) smallpox vaccination in a group of adult primary smallpox vaccines.
Time frame
Within 35 days following the 2-dose series of a novel, replication-deficient (JYNNEOS™) smallpox vaccineLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Womack Army Medical Center
Lead sponsor
United States Naval Medical Center, San Diego
Collaborator
C.R.Darnall Army Medical Center
Collaborator
Source ClinicalTrials.gov
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