The research is proposed to people at risk of infection with the monkey pox virus (Monkey pox), and to whom an anti-pox vaccine is proposed according to the health authorities recommandations (JYNNEOS or IMVANEX).
Conditions
Interventions
Trade Name: JYNNEOS
Product Name: JYNNEOS
Pharmaceutical Form: Solution for injection
Trade Name: IMVANEX
Product Name: IMVANEX
Pharmaceutical Form: Solution for injection
Sponsors
Assistance Publique – Hôpitaux de Paris (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age = 18 years old - Be a contact person at risk of exposure to the Monkeypox virus as validated by Public Health France (SPF) for less than 14 days following the last contact with the case and not vaccinated OR Be a contact person at risk of exposure to the Monkeypox virus as validated by SPF and having received a first post-exposure injection less than 28 days ago - Signature of informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: - Being under guardianship or curatorship - No coverage by social security - Subject subject to a legal protection measure - Have a contraindication to Monkeypox vaccination - Present a known or suspected allergy to one of the components of the vaccine - Diagnosis of Monkeypox
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the post-exposure vaccination failure rate after one dose of the vaccine in Monkeypox contact subjects at risk;Secondary Objective: 1. Assess early vaccine humoral immunogenicity 2. Assess vaccine humoral immunogenicity after one, two or even three doses of vaccine administered post-exposure 3. Assess Factors Associated with the Immune Response 4. Assess the proportion of failures and their clinical presentations according to the time between exposure and vaccination 5. Effectiveness of PEV 6. Assess vaccine reactogenicity after each dose of vaccine 7. Assess the acceptability of post-exposure vaccination 8. Prevalence of sexually transmitted infections at baseline 9. Assess the transmissibility of asymptomatic forms 10. Cellular immunity to MVA vaccination (under study on 30 subjects);Primary end point(s): Proportion of participants with post-exposure vaccination failure, failure being defined by a positive MKPXV PCR within 28 days after the 1st vaccine dose (blood, or urine, or skin or oropharyngeal PCR).;Timepoint(s) of evaluation of this end point: 28 days after the first dose of vaccine | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Anti-poxvirus antibody titer on the day of the first dose, 7 days and 14 days after the 1st dose 2. Anti-poxvirus antibody titer at 1 month, 43 days, 3 months after the 1st dose 3. Factors found to be statistically associated with immune response or failure against MKPXV 4. Proportions of failures and clinical presentation in vaccinees 10 days 5. Comparison of the number of infections in vaccinated and unvaccinated 6. Any adverse effects occurring up to 3 months after the 1st dose 7. Proportion of people accepting vaccination 8. HIV, HAV, HBV, HCV, Syphilis seropositivity at baseline 9. Detection of monkeypox virus in samples 10. Study of cellular immunity (30 subjects);Timepoint(s) of evaluation of this end point: Up to 3 month after the first dose of vaccine | — |
Countries
France
Contacts
Public ContactChristophe AUCAN
Assistance Publique – Hôpitaux de Paris (AP-HP)
Outcome results
None listed