Clinical trial NCT05522296: Break-through Infection Following Mpox vaccinatIon
Official title: Break-through Infection Following Mpox vaccinatIon: Target Trial Emulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mpox
Keywords: Monkeypox
Mpox Vaccine
Intradermal Mpox vaccine
Mpox
Lead sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Sponsor class: OTHER
Collaborators: name: Department of Health, Generalitat de Catalunya
name: Hospital Vall d'Hebron
name: Hospital Clinic of Barcelona
name: Hospital Universitario 12 de Octubre
name: Public Health Service of Madrid
name: Madrid Salud
name: Harvard School of Public Health (HSPH)
name: London School of Hygiene and Tropical Medicine
name: Germans Trias i Pujol Hospital
name: BCN Checkpoint
name: Centro de Saluld Sandoval
name: Centro de Salud Montesa
name: Hospital Nacional Arzobispo Loayza
name: Hospital Regional III Honorio Delgado
name: Hospital Regional Docente de Trujillo
name: Instituto Conmemorativo Gorgas de Estudios de la Salud
name: Ministerio de Salud de Panamá
name: Fundación Arriaran
First posted: 2022-08-31
Enrollment: 3125
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Vaccinated and unvaccinated individuals who have risk factors for mpox infection and do not have a past history of mpox infection.

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.

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.

Primary outcomes:
measure: Polymerase chain reaction (PCR)-confirmed mpox infection
timeFrame: From 14 days after the index date to twelve months after the index date
Secondary outcomes:
measure: Polymerase chain reaction (PCR)-confirmed mpox infection
timeFrame: From immediately after the index date to twelve months after the index date
measure: Duration of general symptoms
timeFrame: From 14 days after the index date to twelve months after the index date
measure: Severity of rash
timeFrame: From 14 days after the index date to twelve months after the index date
measure: Duration of skin rash
timeFrame: From 14 days after the index date to twelve months after the index date
measure: Medical treatment
timeFrame: From 14 days after the index date to twelve months after the index date
measure: Hospitalization
timeFrame: From 14 days after the index date to twelve months after the index date
measure: Scarring
timeFrame: From 14 days after the index date to twelve months after the index date
measure: Safety and tolerability
timeFrame: One month after vaccination
Other outcomes:
Locations:
city: Santiago de Chile
country: Chile
facility: Hospital Clínico San Borja Arriarán
state: Región Metropolitana
city: Panamá
country: Panama
facility: Instituto Conmemorativo Gorgas de Estudios de la Salud (ICGES)
city: Arequipa
country: Peru
facility: Hospital Regional III Honorio Delgado
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza
city: Trujillo
country: Peru
facility: Hospital Regional Docente de Trujillo
city: Badalona
country: Spain
facility: Germans Trias i Pujol Hospital
state: Barcelona
Study officials:
References:
citation: Barda N, Dagan N, Ben-Shlomo Y, Kepten E, Waxman J, Ohana R, Hernan MA, Lipsitch M, Kohane I, Netzer D, Reis BY, Balicer RD. Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. N Engl J Med. 2021 Sep 16;385(12):1078-1090. doi: 10.1056/NEJMoa2110475. Epub 2021 Aug 25.