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

NCT02977715 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1600

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

  • Monkeypox Virus Infection

Interventions

BIOLOGICAL

JYNNEOS (Liquid Formulation)

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.

BIOLOGICAL

JYNNEOS (Lyophilized Formulation)

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.

Sponsors & Collaborators

  • Ministry of Public Health, Democratic Republic of the Congo

    collaborator OTHER_GOV

  • Kinshasa School of Public Health

    collaborator OTHER

  • Bavarian Nordic

    collaborator INDUSTRY

  • Centers for Disease Control and Prevention

    lead FED

Principal Investigators

  • Faisal Minhaj, Pharm.D., MPH, DABAT · Centers for Disease Control and Prevention

  • Kinkodi Didine Kaba, MD, PhD · DRC

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-23
Primary Completion
2025-10-31
Completion
2025-10-31
FDA Drug
Yes

Countries

  • Democratic Republic of the Congo

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02977715 on ClinicalTrials.gov