← Back to Search

Virus Therapy

JYNNEOS Vaccine 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
Individuals 18 - 50 years of age inclusive at the time of consent; OR Adolescent ages 12 to 17 years inclusive at the time of consent.
Individuals with HIV must be on suppressive ART for at least 6 months, report a CD4 count of greater than 350 cells/µL and no AIDS-defining illness in the last year.
Must not have
Ever received a licensed or an investigational smallpox or monkeypox vaccine.
*This includes Dryvax, Acam2000, LC 16 m8, MVA-based vaccine candidate or licensed vaccines, and Jynneos, Imvamune or Imvanex)
Timeline
Screening 1 day
Treatment 13 months
Follow Up day 1 through day 394
Awards & highlights

Summary

This trial will compare two vaccine regimens to the standard in adults and adolescents to see which one is better.

Who is the study for?
This trial is for healthy adults aged 18-50 and adolescents 12-17 who have never had a smallpox or monkeypox vaccine, no history of certain pox infections, not immunocompromised, and not on recent immunosuppressing meds. Women must agree to use effective contraception. Participants with stable chronic conditions including well-controlled HIV can join.Check my eligibility
What is being tested?
The study tests two different dosages of the MVA-BN vaccine given intradermally (ID) against the standard dose given subcutaneously (SC) in adults. It aims to see if the immune response with lower ID doses is just as good as the standard SC dose. Adolescents will receive the standard SC regimen for comparison.See study design
What are the potential side effects?
While specific side effects are not listed here, vaccines like JYNNEOS may cause reactions at injection site such as pain and redness, muscle aches, headache, fatigue, nausea or mild fever. Serious allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 50 years old.
Select...
I have HIV, on ART for 6+ months, CD4 count >350, no AIDS illness last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been vaccinated against smallpox or monkeypox.
Select...
I have received a smallpox vaccine.
Select...
I haven't taken any immunosuppressing drugs in the last 4 weeks.
Select...
I haven't taken more than 20 mg/day of prednisone or its equivalent for 2 weeks in the last month.

Timeline

Screening ~ 1 day
Treatment ~ 13 months
Follow Up ~day 1 through day 394
This trial's timeline: 1 day for screening, 13 months for treatment, and day 1 through day 394 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline Vaccinia virus specific plaque reduction neutralizing antibody (PRNT) Geometric Mean Titers (GMT)
Occurrence of Adverse Events of Special Interest (AESI).
Occurrence of Medically Attended Events (MAAE)
+3 more
Secondary outcome measures
Change from baseline in Vaccinia virus specific plaque reduction neutralizing antibody (PRNT) Geometric Mean Titers (GMT)
Change from baseline in peak Geometric Mean Titers (GMT)
Frequency of withdrawals or discontinuation of vaccination
+10 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

2Treatment groups
Experimental Treatment
Active Control
Group I: 5Experimental Treatment1 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 adolescents ages 12-17 years on Days 1 and 29. N=315
Group II: 4Active 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 adults ages 18-50 years on Days 1 and 29. N=135

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,283 Previous Clinical Trials
5,498,482 Total Patients Enrolled
4 Trials studying Monkeypox
2,359 Patients Enrolled for Monkeypox

Media Library

JYNNEOS (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05740982 — Phase 2
Monkeypox Research Study Groups: 4, 5
Monkeypox Clinical Trial 2023: JYNNEOS Highlights & Side Effects. Trial Name: NCT05740982 — Phase 2
JYNNEOS (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05740982 — Phase 2
Monkeypox Patient Testimony for trial: Trial Name: NCT05740982 — Phase 2
~200 spots leftby Jul 2025