JYNNEOS Smallpox Vaccine in Adult Healthcare Personnel at Risk for Mpox in the Democratic Republi… (NCT02977715) | Clinical Trial Compass
CompletedPhase 3
JYNNEOS Smallpox Vaccine in Adult Healthcare Personnel at Risk for Mpox in the Democratic Republic of the Congo
Democratic Republic of the Congo1,600 participantsStarted 2017-02-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 mpox infection working in the Tshuapa Province of DRC or laboratory personnel performing diagnostic testing for mpox 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Monkeypox virus infection
Timeframe: 2 years following initial vaccination
2
Monkeypox virus exposure
Timeframe: 2 years following initial vaccination
3
Orthopoxvirus Antibody Response
Timeframe: Days 0, 14, 28, 42, 180, 365, 545, and 730 days after the receipt of the first dose of vaccine; Days 3, 7, and/or 14, and through study completion (an average of 1 year) after receipt of single booster dose of vaccine.
4
Distribution of Geometric Means Titers (GMTs)
Timeframe: Days 0, 14, 28, 42, 180, 365, 545, and 730 days after the receipt of the first dose of vaccine; Days 3, 7, and/or 14, and through study completion (an average of 1 year) after receipt of single booster dose of vaccine.
5
Adverse event and serious adverse event information
Timeframe: 2 years following initial vaccination; Day 3, 7, and/or 14 after receipt of single booster dose of vaccine
. 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.