Follow-up of Contact Persons at Risk of Monkeypox infectio

Phase 1

• Conditions: 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).; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2022-002352-39-FR
• Lead Sponsor: Assistance Publique – Hôpitaux de Paris (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-20
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 226

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified