JYNNEOS Vaccine for Monkeypox
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the JYNNEOS vaccine to determine its effectiveness and safety for adolescents aged 12 to 17 compared to adults aged 18 to 50. Researchers aim to compare the immune response (how the body defends itself) after vaccination between these two groups. The trial seeks healthy individuals who have never received a smallpox or monkeypox vaccine. Those with stable chronic conditions, such as controlled HIV, might still qualify. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are using immunosuppressing medications or high doses of certain steroids, you may not be eligible. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that the JYNNEOS vaccine was well-tolerated in past studies. This vaccine, used for smallpox and monkeypox, does not contain a virus that can grow in humans, reducing the risk of illness from the vaccine itself. Real-world data from its widespread use confirms its safety when administered as a shot under the skin.
In these studies, most side effects were mild, such as redness, swelling, or pain at the injection site. Other common effects included fatigue or headache, typical for vaccines. Serious side effects were rare. The JYNNEOS vaccine is already approved for adults, indicating its safety. This trial will help confirm its safety in teenagers.12345Why do researchers think this study treatment might be promising for monkeypox?
Researchers are excited about the JYNNEOS vaccine for monkeypox because it uses a non-replicating modified vaccinia virus, known as Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), which is designed to be safer for a wider range of people, including those with weakened immune systems. Unlike some existing smallpox vaccines, which can have significant side effects, JYNNEOS is administered subcutaneously and is generally well-tolerated. This vaccine is being tested in both adults and adolescents, aiming to provide broader protection across different age groups without the risks associated with live, replicating viruses.
What evidence suggests that the JYNNEOS vaccine is effective for monkeypox?
Research has shown that the JYNNEOS vaccine helps prevent mpox (monkeypox). This trial will evaluate the vaccine in two groups: adults ages 18-50 and adolescents ages 12-17. Studies have found that two doses of the vaccine offer better protection than one dose. Specifically, one study showed that two doses were 66% effective in preventing infection. Another study found that one dose was 58% effective, but two doses are recommended for stronger protection. Overall, the JYNNEOS vaccine is a proven method to prevent mpox, especially for those at high risk.678910
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a 2-dose 1 x 10^8 TCID50 MVA-BN regimen administered subcutaneously on Days 1 and 29
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- JYNNEOS
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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
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
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Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Citations
Effectiveness of modified vaccinia Ankara-Bavarian Nordic ...
Estimated vaccine effectiveness of one dose of MVA-BN against mpox infection was 58% (95% CI 31% to 75%). Conclusion: The findings of this study ...
Vaccine Effectiveness of JYNNEOS against Mpox Disease ...
The findings suggest that JYNNEOS vaccine was effective in preventing mpox disease, and a two-dose series appeared to provide better protection.
Effectiveness of Modified Vaccinia Ankara-Bavaria Nordic ...
These results confirm that MVA-BN vaccination is an effective prevention tool in a population at high risk of MPXV infection, at least shortly after vaccine ...
Decline of Mpox Antibody Responses After Modified ...
Two doses of MVA-BN are recommended, although some individuals received only 1 dose. Two doses provided 66% effectiveness and 1 dose provided 36 ...
MVA-BN vaccine effectiveness: A systematic review of real- ...
The reported VE estimates against mpox infection demonstrated the effectiveness of one or two doses of MVA-BN in the context of an outbreak across multiple ...
Package Insert - JYNNEOS (Refrigerator)
The safety of JYNNEOS one-vial presentation in smallpox vaccine-naïve participants was evaluated in Study 1 [1], a randomized, double-blind, placebo-controlled ...
MVA-BN (Modified Vaccinia Ankara – Bavarian Nordic) ...
The MVA-BN (live Modified Vaccinia Ankara) vaccine is a third-generation smallpox vaccine, which contains a virus that cannot replicate in humans.
Real-world safety data for MVA-BN: Increased frequency of ...
Real-world data from large-scale administration of MVA-BN has confirmed the vaccine's established safety profile when administered subcutaneously.
Safety and effectiveness of MVA-BN vaccination against ...
The third-generation smallpox vaccine modified vaccinia Ankara–Bavarian Nordic (MVA-BN) was recommended for at-risk populations in 2022, despite ...
Mpox Vaccines | NIAID
Researchers found that that the immune responses induced by the JYNNEOS vaccine or the ACAM2000 smallpox vaccine were not significantly affected ...
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