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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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 365
Awards & highlights

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.

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
3,283 Previous Clinical Trials
5,498,703 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
~81 spots leftby Jul 2025
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