Prospective Assessment of Myocarditis After Replication-Deficient Smallpox Immunization

Receipt of the novel smallpox vaccine JYNNEOS® is a requirement for study participation. Prior to enrollment, potential participants will complete a routine adult immunization screening questionnaire (standard of care) and be reviewed by study team for eligibility prior to enrollment.

The entry questionnaires and copy of medical treatment facility (MTF) records and/or Immunization Tracking System documentation will provide baseline demographic and past medical history with specific attention paid to prior immunization history, past medical history of known atopy, HIV disease, coronary artery disease or myocardial infarction, diabetes, carotid artery disease, stroke, or other cardiac disease risk factors such as hyperlipidemia, smoking, hypertension, obesity, etc. All medications being taken prior to enrollment and throughout the study will be documented. The symptom diary/survey will serve as the vehicle to identify symptom and medication changes during study participation. Subjects will use the Defense and Veterans rating scale to rate their pain. The smallpox entry questionnaire, symptom diary and medication log are study-related. A routine screening immunization questionnaire will be completed and the screening form must not have any contraindication identified for the JYNNEOS® vaccine for consideration of enrollment (standard of care). Laboratory tests and ECGs are not standard of care for receiving smallpox vaccination, but are study-related. Participants who develop new onset cardiac symptoms or other symptoms suggestive of possible cardiac involvement which might meet the CDC/DoD case definition of suspect, probable or confirmed myopericarditis, will be referred to Defense Health Agency-Immunization Healthcare Division (DHA-IHD) clinical team as well as cardiology and/or the emergency department for further evaluation. Further ECGs, cardiac biomarkers, cardiac imaging for such participants would be standard of care.

Assigning Subject Identification Numbers:

Upon consent, the subject will be randomly assigned a subject ID number. Subjects requiring concomitant vaccines along with JYNNEOS® will be randomly assigned to one of two groups (1:1 allocation) and that simple computer-generated randomization will be concealed to research staff. The link between subject ID numbers and their names and dates of consent will be maintained at the DHA-IHD research office in a locked filing cabinet within locked offices, and/or in secure, password-protected electronic files, only accessible to the research study team. The linkage document will be destroyed after completion of the final data analysis and IRB acknowledgment/approval of study closure.

Location and Personnel for Study Procedures: