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Virus Vaccine

JYNNEOS Dosing Strategies for Monkeypox

Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If HIV infected individual, they must be on suppressive Antiretroviral therapy (ART) for at least 6 months, report a cluster of differentiation 4 (CD4) count of greater than 350 cells/uL and no Acquired Immune Deficiency Syndrome (AIDS)-defining illness in the last year
Individuals 18 - 50 years of age inclusive at the time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 365
Awards & highlights

Study Summary

This trial will compare two lower doses of the MVA-BN vaccine given intradermally to the standard dose given subcutaneously in order to see if there is a non-inferior response in terms of humoral immunity.

Who is the study for?
Healthy adults aged 18-50, without prior monkeypox or similar infections, not immunocompromised, and with no recent vaccines. Women must use effective contraception. HIV-positive individuals can join if they're stable on ART with a CD4 count over 350 cells/uL.Check my eligibility
What is being tested?
The trial is testing two lower-dose intradermal regimens of the MVA-BN monkeypox vaccine against the standard subcutaneous dose to see if they produce a similar immune response in healthy adults.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include typical vaccine reactions such as pain at injection site, redness, swelling, fatigue, headache and possible mild fever.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am HIV positive, on ART for 6+ months, CD4 count >350, no AIDS illness in the last year.
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I am between 18 and 50 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 365
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 365 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vaccinia Virus Specific Plaque Reduction Neutralization Test (PRNT) Geometric Mean Titer (GMT) at Day 43
Secondary outcome measures
Individual Peak GMT Through Day 365
Number of Participants Reporting Related and Unrelated Medically Attended Adverse Events (MAAEs)
Number of Participants Reporting Related and Unrelated Serious Adverse Events (SAEs)
+6 more

Side effects data

From 2014 Phase 3 trial • 4005 Patients • NCT01144637
3%
Upper respiratory tract infection
1%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 4
Group 3
Group 2
Group 1

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2Experimental Treatment1 Intervention
0.05 mL of 1 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29. N=70
Group II: Arm 1Experimental Treatment1 Intervention
0.1 mL of 2 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29. N=70
Group III: Arm 3Active Control1 Intervention
0.5 mL of 1 x 10^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29. N=70

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,480,903 Total Patients Enrolled
3 Trials studying Monkeypox
2,130 Patients Enrolled for Monkeypox

Media Library

JYNNEOS (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05512949 — Phase 2
Monkeypox Research Study Groups: Arm 1, Arm 2, Arm 3
Monkeypox Clinical Trial 2023: JYNNEOS Highlights & Side Effects. Trial Name: NCT05512949 — Phase 2
JYNNEOS (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05512949 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are participating in this experiment?

"A total of 210 compliant patients are necessary to complete the trial. Individuals can join from various sites, such as The GW Vaccine Research Unit in Washington DC and Baylor College of Medicine-Vaccine Research Center in Houston tx."

Answered by AI

Does this trial include individuals younger than fifty years of age?

"Patients aged 18 to 50 must meet the eligibility requirements for this clinical trial. Additionally, there are 3 trials designed specifically for those under 18 years old and 6 which focus on elderly individuals over 65."

Answered by AI

What criteria should be used to determine eligibility for this experiment?

"The requirements for eligibility in this monkeypox trial are a verified diagnosis as well as ages between 18 and 50. Currently, 210 patients have been accepted into the study."

Answered by AI

What hazards have been observed in connection to JYNNEOS usage?

"Our analysis at Power gave JYNNEOS a score of 2, as clinical trials are only in Phase 2, indicating that while data exists to support the drug's safety there is no evidence yet affirming its efficacy."

Answered by AI

Is this experiment presently welcomed to participants?

"Per the information provided on clinicaltrials.gov, this trial is currently enrolling patients. It was posted to the website on September 7th 2022 and updated lastly on November 23rd of the same year."

Answered by AI

In what quantity of healthcare facilities is this clinical trial currently being conducted?

"This trial is open for recruitment at 16 different sites, such as The GW Vaccine Research Unit in Washington D.C., Baylor College of Medicine-Vaccine Research Center in Houston and the Hope Clinic of Emory University in Decatur, among others."

Answered by AI

Who else is applying?

What site did they apply to?
University of California, San Diego - Antiviral Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
~89 spots leftby Apr 2025