drugset / Trial / NCT02977715

JYNNEOS Smallpox Vaccine in Adult Healthcare Personnel at Risk for Mpox in the Democratic Republic of the Congo

NCT02977715

Non-randomizedSequentialOpen-labelPrevention

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.

Timeline

Start
2017-02-23
Primary completion
2025-10-31
Completion
2025-10-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject IMVAMUNE Vaccine 1e+08 unknown Subcutaneous

Indications