Break-through Infection Following Mpox vaccinatIon: Target Trial Emulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,125
- 试验地点
- 6
- 主要终点
- Polymerase chain reaction (PCR)-confirmed mpox infection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 18 years or older.
- •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.
- •Signature of informed consent.
排除标准
- •Unable to provide signature of informed consent.
- •Past infection with monkeypox.
- •Past smallpox vaccination.
研究组 & 干预措施
Vaccinated
Vaccinated individuals with smallpox and mpox vaccine (Live Modified Vaccinia Virus Ankara) who have risk factors for monkeypox infection and do not have a past history of mpox infection.
干预措施: Mpox Vaccine (Drug)
结局指标
主要结局
Polymerase chain reaction (PCR)-confirmed mpox infection
时间窗: From 14 days after the index date to twelve months after the index date
Mpox PCR positivity in participants with mpox infection symptoms
次要结局
- Duration of general symptoms(From 14 days after the index date to twelve months after the index date)
- Medical treatment(From 14 days after the index date to twelve months after the index date)
- Hospitalization(From 14 days after the index date to twelve months after the index date)
- Polymerase chain reaction (PCR)-confirmed mpox infection(From immediately after the index date to twelve months after the index date)
- Severity of rash(From 14 days after the index date to twelve months after the index date)
- Duration of skin rash(From 14 days after the index date to twelve months after the index date)
- Scarring(From 14 days after the index date to twelve months after the index date)
- Safety and tolerability(One month after vaccination)
研究者
Oriol Mitja
Associate Professor, Infectious Diseases and Global Health
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia