At a glance
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An Open-Label Prospective Cohort Study of JYNNEOS Smallpox Vaccine in Adult Healthcare Personnel at Risk for Mpox in the Democratic Republic of the Congo
In Brief
A Phase 3 clinical trial evaluating JYNNEOS (Liquid Formulation) and JYNNEOS (Lyophilized Formulation) for Monkeypox Virus Infection. Completed, enrolled 1,600 participants across 1 site.
Detailed Summary
Mpox is a febrile rash illness caused by the monkeypox virus. Its natural occurrence in the DRC puts healthcare and frontline workers at high risk of acquiring monkeypox virus infections that can prevent them from performing work duties, compromise the overall healthcare delivery in an already fragile system, and can result in death (case fatality estimates are approximately 10%). This is an open-label prospective cohort study in up to 1,600 eligible healthcare workers at risk of mpox infection through their daily work. The study will document mpox exposure and infection in participants while concurrently evaluating the immunogenicity and safety of the vaccine, JYNNEOS (also known as MVA-BN, IMVAMUNE®, IMVANEX), in healthcare personnel in the DRC. Participation in the study is voluntary and open to male and female healthcare personnel ages 18 years and older in Tshuapa Province in The Democratic Republic of Congo who are at risk of monkeypox virus infection through their daily work or laboratory personnel performing diagnostic testing for monkeypox virus.
Study Details
Timeline
Interventions
Two doses of attenuated live virus smallpox vaccine (JYNNEOS liquid formulation) administered on days 0 and 28 via subcutaneous injection (deltoid) (1 x 10\^8 Tissue Culture Infectious Dose 50 \[TCID50\] per 0.5 mL). A subset of participants will receive a booster dose.
Two doses of attenuated live virus smallpox vaccine (JYNNEOS lyophilized formulation) administered on days 0 and 28 via subcutaneous injection (deltoid) (1 x 10\^8 Tissue Culture Infectious Dose 50 \[TCID50\] per 0.5 mL). A subset of participants will receive a booster dose.