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Clinical trial

Break-through Infection Following Mpox vaccinatIon: Target Trial Emulation

ID
Name
REMAIN
Description
The purpose of this study is to assess the protection of smallpox preexposure vaccination against infection with mpox in real-world individuals with risk factors for mpox.
Trial arms
Trial start
2022-09-12
Estimated PCD
2024-03-30
Trial end
2024-03-30
Status
Completed
Treatment
Mpox Vaccine
Vaccination with smallpox and mpox vaccine (Live Modified Vaccinia Virus Ankara)
Arms:
Vaccinated
Size
3125
Primary endpoint
Polymerase chain reaction (PCR)-confirmed mpox infection
From 14 days after the index date to twelve months after the index date
Eligibility criteria
Inclusion Criteria: 1. Individuals aged 18 years or older. 2. Individuals with general risk factors for mpox infection, as currently defined by the local guidelines for vaccination. These risk factors include at least one of the following items: * Individual-reported use of HIV pre-exposure prophylaxis (PrEP). * Individual-reported chemsex practices * Individual-reported multiple sexual partners. * Individuals with a history of a sexually transmitted infection (STI) in the past year. * Individuals living with HIV infection. 3. Signature of informed consent. Exclusion Criteria: 1. Unable to provide signature of informed consent. 2. Past infection with monkeypox. 3. Past smallpox vaccination.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '18 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 3125, 'type': 'ACTUAL'}}
Updated at
2024-06-06

1 organization

1 product

1 indication

Organization
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Product
Mpox Vaccine
Indication
Molluscum contagiosum