Actively Recruiting
Evaluation of Long-term Immunogenicity of a Boost Dose of MVA-BN Vaccine
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-05-15
90
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the long-term immune response to a booster dose of the MVA-BN vaccine, which is designed to prevent mpox, a viral disease caused by the MPXV virus. This research focuses on men who have sex with men (MSM) using HIV pre-exposure prophylaxis (PrEP), a key group at risk. The study is observational and aims to provide more information on how durable the vaccine's protection is after a booster dose, following recommendations due to recent outbreaks and public health concerns worldwide. Participants in this study have previously received two doses of the MVA-BN vaccine and are eligible for a booster dose as per health guidelines. The study will observe these individuals over time without assigning treatments, monitoring their immune responses after the booster dose. The trial will track immune system markers and any mpox infections to understand the vaccine's long-term effects. During the study, participants will be followed for up to 24 months, with evaluations of their immune response and safety after receiving the booster dose. Researchers will collect data on antibody levels at 12 and 24 months, observe the pattern of immune response, and document any cases of mpox infection. The study involves regular medical monitoring and aims to gather detailed information about how the booster dose supports immunity in this population.
CONDITIONS
Brief Title
Evaluation of Long-term Immunogenicity of a Boost Dose of MVA-BN Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged over 18 years
- Have received two doses of MVA-BN vaccine as an initial schedule
- Eligible for a booster dose of MVA-BN according to HAS recommendations
- Eligible for and willing to start or currently using HIV pre-exposure prophylaxis (PrEP) treatment
- Covered by social security (excluding AME)
You will not qualify if you...
- History of virologically confirmed mpox infection
- Under guardianship or curatorship
- Subject to a judicial protection measure
- Have a contraindication to mpox vaccination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 months
Participants are monitored to evaluate the immunogenicity and safety of the MVA-BN booster dose over time.
Multiple visits over 24 months to assess immune response and safety
Trial Site Locations
Total: 1 location
1
CIC 1417Cochin-Pasteur
Paris, Paris, France, 75679
Actively Recruiting
Research Team
L
Liem Binh Luong Nguyen, Degree medical doctor
O
Odile LAUNAY, PUPH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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