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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.
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
No Placebo-Only Group
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.
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.
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 belowSelect...
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 day0 visits
Treatment ~ 13 months8 visits
Follow Up ~ day 1 through day 394
Screening ~ 1 day
Treatment ~ 13 months
Follow Up ~day 1 through day 394
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
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 moreSide effects data
From 2023 Phase 2 trial • 229 Patients • NCT0551294985%
Injection site pruritus
83%
Injection site erythema
77%
Injection site discolouration
68%
Injection site nodule
65%
Injection site pain
57%
Fatigue
49%
Injection site induration
48%
Headache
32%
Myalgia
24%
Arthralgia
23%
Nausea
20%
Chills
15%
Appetite disorder
12%
Injection site exfoliation
7%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
2 x 10^7 ID MVA-BN
1 x 10^8 SC MVA-BN
1 x 10^7 ID MVA-BN
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JYNNEOS
2022
Completed Phase 2
~230
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
3,312 Previous Clinical Trials
5,546,806 Total Patients Enrolled
4 Trials studying Monkeypox
1,591 Patients Enrolled for Monkeypox
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can read and agree to follow the study's procedures and attend all visits.I have HIV, on ART for 6+ months, CD4 count >350, no AIDS illness last year.You have a heart condition that makes participating in the study risky, such as a history of inflammation of the heart or a structural heart defect.I have received a smallpox vaccine.My chronic conditions have been stable and haven't required hospitalization or major treatment changes in the last month.I have not received and do not plan to receive any vaccines within a week of the study vaccination.You have had a serious reaction or anaphylaxis in the past after receiving a vaccine.I haven't had and won't get a live vaccine around the time of my trial participation.I am between 12 and 50 years old.I haven't taken more than 20 mg/day of prednisone or its equivalent for 2 weeks in the last month.Your immune system is weak, as decided by the doctor in charge.I have been vaccinated against smallpox or monkeypox.I haven't taken any immunosuppressing drugs in the last 4 weeks.You have taken a new or experimental drug or vaccine within the past 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: 4
- Group 2: 5
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 13 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Monkeypox Patient Testimony for trial: Trial Name: NCT05740982 — Phase 2
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