Evaluation of Long-term Immunogenicity of a Boost Dose of MVA-BN Vaccine
ConditionMonkeypox
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
This study is to evaluate the long-term immunogenicity of a boost dose of MVA-BN vaccine
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 the HAS recommendation)
Be eligible and wish to initiate PrEP-HIV treatment or be followed for PrEP-HIV treatment
Disqualifiers
History of mpox (virologically confirmed)
Be under guardianship or curatorship
Be subject to a judicial protection measure
Have a contraindication to vaccination against mpox
Trial population
The study population will consist of Men who have Sex with Men (MSM), taking HIV pre-exposure prophylaxis (HIV PrEP), eligible for MVA-BN vaccination.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Immunogenicity a of a booster dose of MVA-BN vaccine
To evaluate the immunogenicity at 12 months of a booster dose of MVA-BN vaccine administered subcutaneously in HIV PrEP users.
Time frame
12 monthsSecondary outcomes
1
Persistence of humoral immunogenicity
Evaluate the persistence of humoral immunogenicity at 24 months of a booster dose, depending on the number of doses and the interval between doses
Time frame
24 months2
Kinetics of the humoral response
Study the kinetics of the humoral response as a function of the number of doses and the interval between doses
Time frame
24 months3
Description of cases of Mpox infection
Describe cases of Mpox infection based on number of doses and dose interval up to 24 month
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov