MVA-BN Vaccine for Monkeypox
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a vaccine for monkeypox to evaluate its effectiveness and safety. Researchers compare two versions of the MVA-BN vaccine: one made with chicken cells and the other with quail cells. The study seeks healthy adults who have not been vaccinated for smallpox or similar viruses and have not had monkeypox. Recent contact with someone with monkeypox may disqualify participation. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop taking my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, certain conditions and treatments, like chronic use of immune-modifying drugs or recent vaccinations, may affect your eligibility. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the MVA-BN vaccine is safe. In large studies, participants generally handled the vaccine well when administered as a shot under the skin. Most experience only mild side effects, such as redness, itching, or swelling at the injection site. Occasionally, pain and swelling may occur in that area as well. These reactions are common and typically resolve on their own.
This vaccine is already recommended for individuals at risk of monkeypox, indicating trust in its safety. The European Medicines Agency also approves it for protection against monkeypox and vaccinia virus infections. While mild reactions can occur, serious issues are rare. Evidence suggests that the MVA-BN vaccine is safe for use.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the MVA-BN vaccine for monkeypox because it offers a new approach to combating the virus. Unlike traditional treatments that often involve antiviral drugs like tecovirimat, MVA-BN is a vaccine designed to stimulate the body's immune system to fight off monkeypox more effectively. The vaccine utilizes a modified vaccinia virus, which is non-replicating but still capable of inducing a strong immune response, potentially providing better protection and fewer side effects. This innovative approach could lead to a more efficient and safer option for preventing monkeypox outbreaks.
What evidence suggests that this trial's treatments could be effective for monkeypox?
Research has shown that the MVA-BN vaccine effectively prevents monkeypox. This trial will compare two formulations of the MVA-BN vaccine: Group 1 will receive MVA-BN (CEF), and Group 2 will receive MVA-BN (Quail). Studies have found that the vaccine's effectiveness ranges from 35% to 89% in preventing the disease. Specifically, one study found that the vaccine reduced the risk of monkeypox by 86% in men at higher risk. Another study demonstrated that a single dose of the vaccine was 58% effective in preventing monkeypox infection. Overall, the MVA-BN vaccine has consistently provided strong protection against monkeypox.46789
Are You a Good Fit for This Trial?
Adults aged 18-49 in good health, with no medical issues that could affect the trial, can join. They must understand and sign a consent form. Participants need a BMI between 18.5 and 35 and agree to use effective birth control from one month before until after their last vaccine dose.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive two doses of the MVA-BN vaccine manufactured in different production cells
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MVA-BN
Trial Overview
This phase 2b trial is testing the MVA-BN vaccine for Monkeypox made in two different cell types: chicken embryo fibroblast cells and quail cells. It's randomized and double-blind, meaning neither participants nor researchers know who gets which vaccine type.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
MVA-BN (Quail)
MVA-BN (CEF)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bavarian Nordic
Lead Sponsor
Paul Chaplin
Bavarian Nordic
Chief Executive Officer since 2014
PhD in Immunology from Bristol University
Jean-Christophe May
Bavarian Nordic
Chief Medical Officer since 2020
PharmD and MBA
ICON plc
Industry Sponsor
Dr. Steve Cutler
ICON plc
Chief Executive Officer since 2017
PhD from the University of Sydney, MBA from the University of Birmingham
Dr. Greg Licholai
ICON plc
Chief Medical Officer since 2023
Degrees from Harvard Business School, Yale School of Medicine, Columbia University, and Boston College
Citations
MVA-BN vaccine effectiveness: A systematic review of real- ...
When MVA-BN was administered as PrEP, the adjusted VE estimates against mpox infection ≥14 days post-vaccination were 35 %–86 % (n = 8 studies) ...
Safety and effectiveness of MVA-BN vaccination against ...
MVA-BN vaccination was safe and well tolerated. One dose of MVA-BN offered protection against mpox but effectiveness was reduced in people ...
Effectiveness and Safety of the MVA–BN Vaccine against ...
The MVA–BN vaccine effectiveness against mpox disease was 89% (95% CI: 12%, 99%) among those fully vaccinated; attenuated to 64% (95% CI: 40%, 78%) among those ...
Vaccine Effectiveness of JYNNEOS against Mpox Disease ...
A cohort study from Israel showed that MVA vaccine was associated with an 86% decrease in the incidence of mpox disease among men receiving HIV PrEP or men ...
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 ...
MVA-BN Safety Data: Syncope After Intradermal Mpox Vaccine
Real-world data from large-scale administration of MVA-BN has confirmed the vaccine's established safety profile when administered subcutaneously.
Effectiveness of Modified Vaccinia Ankara-Bavaria Nordic ...
One dose of MVA-BN vaccine offered protection against mpox in most-at-risk population shortly after the vaccination. Further studies need to assess the VE of a ...
Short-term Adverse Events: MVA-BN Mpox Vaccine
The most common adverse events were local redness, itching, and swelling following intradermal vaccination and local pain, swelling, and redness following ...
Imvanex | European Medicines Agency (EMA)
Imvanex can also be used to protect adults and adolescents aged 12 years and older from mpox (formerly monkeypox) and disease caused by the vaccinia virus.
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