IMVAMUNE® Smallpox Vaccine in Adult Healthcare Personnel at Risk for Monkeypox in the Democratic Republic of the Congo
Monkeypox Virus Infection
About this trial
This is an interventional prevention trial for Monkeypox Virus Infection focused on measuring Democratic Republic of the Congo, IMVAMUNE, Modified Vaccinia Ankara (MVA), Monkeypox, Orthopoxvirus, Vaccine, Vaccinia virus, JYNNEOS
Eligibility Criteria
Inclusion Criteria:
- Males and nonpregnant females (as indicated by a negative urine pregnancy test prior to first dose of vaccine) age 18 years and older.
- Healthcare personnel at risk of monkeypox infection working in the Tshuapa Province of DRC or laboratory personnel performing diagnostic testing for monkeypox at the time of enrollment
- Willing to adhere to infection control recommendations to the extent possible based on availability of resources.
- Able and willing to complete the informed consent process and study procedures (including blood sample collection, urine pregnancy test, and completion of adverse event diary and exposure forms).
- Available for all study visits.
Exclusion Criteria:
- Any history of allergy or anaphylaxis to any prior vaccines, eggs, or aminoglycosides.
- Current pregnancy (a negative urine pregnancy test is required for women participants who self-report as not pregnant). Enrollment for such participants may be deferred to a later time at which this criteria can be met.
- Acute illness that is accompanied by an axillary temperature ≥37.2°C (99.0°F) at the time of vaccination. Enrollment for such participants may be deferred to a later time at which this criteria can be met.
- Known experimental research agents or other vaccine within 28 days (4 weeks) prior to vaccination. Enrollment for such participants may be deferred to a later time at which this criteria can be met.
- Any reason the PIs suspect that data collected from this person would be incomplete or of poor quality.
- Any condition that the PIs suspect may place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol.
Sites / Locations
- Tshuapa site
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Intervention (Liquid Formulation)
Intervention (Lyophilized Formulation)
Up to 1000 male and female healthcare personnel ages 18 years and older in Tshuapa Province in The Democratic Republic of Congo at risk for monkeypox will receive two doses of attenuated live virus smallpox vaccine (IMVAMUNE liquid formulation) administered on days 0 and 28 via subcutaneous injection (deltoid) (1 x 108 Tissue Culture Infectious Dose 50 [TCID50] per 0.5 mL). A subset of participants will receive a booster dose.
Up to 600 male and female healthcare personnel ages 18 years and older in Tshuapa Province in The Democratic Republic of Congo at risk for monkeypox will receive two doses of attenuated live virus smallpox vaccine (IMVAMUNE lyophilized formulation) administered on days 0 and 28 via subcutaneous injection (deltoid) (1 x 108 Tissue Culture Infectious Dose 50 [TCID50] per 0.5 mL). A subset of participants will receive a booster dose.