Mpox
Conditions
Keywords
Monkeypox, Mpox Vaccine, Intradermal Mpox vaccine, Mpox
Brief summary
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.
Detailed description
A Target Trial Emulation study that tries to emulate the sequential specification of a target trial will be conducted measuring and controlling confounders when there is a common cause of vaccination and outcome event. Participants will be provided with a Quick response (QR) code to access the RedCap study platform, which will guide them to the enrolment process. If the participant accepts and meets all the inclusion and none of the exclusion criteria, they will be directed to a baseline survey to self-collect sociodemographic data and information regarding risk factors, sexual behaviour, vaccination, and exposure to mpox. Newly vaccinated participants will be matched 1:1 to unvaccinated controls. The matching will be performed based on the site of recruitment, and self-reported baseline sexual health and practices. Vaccinated and unvaccinated participants will be matched on variables associated with the probability of infection. Follow-up will include regular surveys every month from the index date (i.e., enrolment date in the unvaccinated group, or vaccination date for the vaccinated group), to collect data on change on risk factors, sexual behaviour in the past month, vaccination status, and exposure to mpox. The participant will be asked to self-report if they develop symptoms suggestive of mpox, and the study platform will direct them to a specific mpox infection survey. For each participant, follow-up will end at the earliest of the following events: mpox infection, voluntary withdraw, or the end of the study period. A health record review will be conducted to corroborate the diagnosis of new cases and to provide validity to the self-report.
Interventions
DRUGMpox Vaccine
Vaccination with smallpox and mpox vaccine (Live Modified Vaccinia Virus Ankara)
Sponsors
Department of Health, Generalitat de Catalunya
Hospital Vall d'Hebron
Hospital Clinic of Barcelona
Hospital Universitario 12 de Octubre
Public Health Service of Madrid
Madrid Salud
Harvard School of Public Health (HSPH)
London School of Hygiene and Tropical Medicine
Germans Trias i Pujol Hospital
BCN Checkpoint
Centro de Saluld Sandoval
Centro de Salud Montesa
Hospital Nacional Arzobispo Loayza
Hospital Regional III Honorio Delgado
Hospital Regional Docente de Trujillo
Instituto Conmemorativo Gorgas de Estudios de la Salud
Ministerio de Salud de Panamá
Fundación Arriaran
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Polymerase chain reaction (PCR)-confirmed mpox infection | From 14 days after the index date to twelve months after the index date | Mpox PCR positivity in participants with mpox infection symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of general symptoms | From 14 days after the index date to twelve months after the index date | Time from onset to resolution of general symptoms in participants with PCR-confirmed mpox infection (in days). |
| Severity of rash | From 14 days after the index date to twelve months after the index date | Number of mpox lesions (lesions count) |
| Duration of skin rash | From 14 days after the index date to twelve months after the index date | Time from onset to resolution of skin rash in participants with PCR-confirmed |
| Polymerase chain reaction (PCR)-confirmed mpox infection | From immediately after the index date to twelve months after the index date | Mpox PCR positivity in participants with mpox infection symptoms |
| Hospitalization | From 14 days after the index date to twelve months after the index date | Requirement of hospital admission (yes/no) |
| Scarring | From 14 days after the index date to twelve months after the index date | Residual scarring after mpox (yes/no) |
| Safety and tolerability | One month after vaccination | Description of systemic and skin reactions |
| Medical treatment | From 14 days after the index date to twelve months after the index date | Requirement of medical treatment (yes/no) |
Countries
Chile, Panama, Peru, Spain
Outcome results
None listed