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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.
Adult participant is able to read the written informed consent, states willingness to comply with all study procedures and is anticipated to be available for all study visits; OR Parent(s)/Legal Authorized Representative (LAR)(s) of the participating adolescent is able to read and provides written informed permission and participating adolescent provides assent as appropriate for age or development and approved by IRB. Adolescent states willingness to comply with all study procedures and is anticipated to be available for all study visits.
Timeline
Screening 1 day
Treatment 13 months
Follow Up day 1 through day 394
Awards & highlights

Study 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
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I am between 12 and 50 years old.
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I can read and agree to follow the study's procedures and attend all visits.
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My chronic conditions have been stable and haven't required hospitalization or major treatment changes in the last month.
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I have HIV, on ART for 6+ months, CD4 count >350, no AIDS illness last year.

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
3,261 Previous Clinical Trials
5,482,556 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: 5, 4
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

Frequently Asked Questions

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

Is this research endeavor open to elderly individuals over eighty-five years of age?

"Participants must be between 12 and 50 years of age to qualify for this clinical trial."

Answered by AI

Could I be a viable participant in this experiment?

"This trial is searching for 400 volunteers between the ages of 12 and 50 who are currently living with monkeypox. Qualified patients must meet these criteria in order to participate."

Answered by AI

Are there any available vacancies in this trial for participants?

"As indicated on clinicaltrials.gov, this medical study is not presently accepting participants. Initially posted in March 15th2023 and last updated February 13th 2023, the trial has yet to begin recruiting patients. However there are 12 other trials that are actively seeking enrolment at the present moment."

Answered by AI

How many medical sites are currently administering this research trial within the state?

"A number of medical centres are taking part in this trial, including The George Washington University Medical Faculty Associates - Infectious Diseases located in the District Of Columbia and National Institutes of Health's Clinical Centre as well as their Laboratory Of Immunoregulation. In addition, Brigham and Women's Hospital is accepting participants for this clinical research study. Altogether there are 13 sites recruiting patients."

Answered by AI

What potential risks and side effects are associated with the use of 5?

"A score of 2 was attributed to the safety profile of compound 5, as it is presently being tested in a Phase 2 clinical trial. That said, there does exist data that supports its security but no evidence yet for its efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
Pennsylvania
Other
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Saint Louis University - Center for Vaccine Development
Kaiser Permanente Washington Health Research Institute
UPMC University Center
Other
How many prior treatments have patients received?
1
3+
0

What questions have other patients asked about this trial?

How many days is it?
PatientReceived no prior treatments

Why did patients apply to this trial?

I want to help people live healthier lives. I am interested in helping medical advancement.
PatientReceived 2+ prior treatments
I am involved with different types of studies through the years. Trying to have some extra cash.
PatientReceived 1 prior treatment
I saw the opportunity to sign up for these trials and I really want to help if I can to advance medicine. I also could use the extra income.
PatientReceived 1 prior treatment
~90 spots leftby Jul 2024