Follow-up of People at Risk of Monkeypox Infection: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Proportion of failure of MVA vaccine
研究概览
简要总结
Since one month (first case confirmed the 05/06/2022), some cases of non-imported were reported by Portuguese and British authorities then in several Europeans countries, the US and the Canada. The 05/19/2022, a first case of Monkeypox was confirmed in France. The 06/01/2022, "Santé Publique France" (SPF) declared 33 confirmed cases of Monkeypox without a direct interaction with people returning from endemic area. No deaths are currently recorded.
Currently, data on efficiency of modified vaccinia Ankara virus (MVA) used in post-exposure prophylaxis are few. The Centers for Disease Control and Prevention (CDC) consider that 2 doses of MVA vaccine used in post-exposure vaccination do not prevent totally the infection but consider that one rapid vaccination of high-risk contacts could reduce the severity of symptoms.
In order to clarify clinical impact and safety of PEV, it is proposed to set up a national cohort including people at risk of Monkeypox infectionfalling within the indications for vaccination, i.e. seen within 14 days of last contact for post-exposition (PEP) cases and also in prevention :pre-exposition ( PrEP)cases.
The purpose of this study is to estimate the failure rate of the vaccinationby the VMA vaccine in PEP or PrEP administration in people at risk of Monkeypox infection after one dose.
详细描述
Indication for Post-Exposure vaccination (PEP) :
PEP has demonstrated its interest in different situations, in particular rabies, tetanus or hepatitis B, as recalled in the report "Guide for post-exposure immunization: vaccination and immunoglobulin" of the High Committee for Public Health in 2016.
For Monkeypox, the PEV was used in 2018 and 2019 in UK, when several import cases were discovered. In 2018, 3 cases were diagnosed and 154 contact cases identified (including 147 healthcare professionals). In total, 131 people have accepted the PEV (including 126 healthcare professionals) and 1 single case among healthcare professionals, having been exposed for 6 to 7 days. In 2019, following an imported case, 17/18 contacts (including children) accepted EPV. No secondary cases or serious adverse effects have been reported.
Several countries have recommended EPV as part of Monkeypox.
Indication for Pre-Exposure vaccination (PrEP):
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PEP group : Be a contact at risk of exposure to the Monkeypox virus as recommended by the HAS within at less 14 days and not vaccinated OR Be a contact at risk of exposure to the Monkeypox virus as recommended by the HAS within at less 14 days and who received the first injection of PEV less than 28 days ago
- •PrEP group : Be identified as belonging to the groups most exposed to MPXV, as defined by HAS, but not be a contact person at risk and not have received an MVA vaccine
- •Signature of informed consent
排除标准
- •Be under guardianship or curatorship
- •No covered by social security
- •Subject to a legal protection measure
- •Have a contraindication to Monkeypox vaccination
- •Have a known or suspected allergy to one of the components of the vaccine- Diagnosis of Monkeypox
结局指标
主要结局
Proportion of failure of MVA vaccine
时间窗: D28 after the first injection for PEP and between 14 days and 3 month for PrEP
Positive PCR MKPXV
次要结局
- Effectiveness of MVA vaccination (PEP vs PrEP)(Day 0, Day 7; Day 14, Day 28, Month 1, 43 Days and 3 Months)
- Assess early vaccine humoral immunogenicity(Day 0, Day 7; Day 14 after the first injection (Day 0))
- Estimate long-term vaccine failure rate (among PrEP or PEP participants)(up to 1 year after the first injection)
- Prevalence of sexually transmitted infections(Day 0)
- Assess the transmissibility of asymptomatic forms(D0, D7, D14, D28, D43 , M3, M6 and M12 after the first injection (D0))
- Estimate the short-term vaccine failure rate after a risky contact(28 days after the first injection)
- Evaluate the proportion of failures and their clinical presentations according to the time between exposure and vaccination(Day 0, Day 7, Day 14, Day 28, 1 month, Day 43 and 3 months)
- Effectiveness of MVAvaccination (PEP and PrEP)(D0, D7; D14, D28, Month 1, 43 Days et 3 Months)
- Assess the acceptability of post-exposure vaccination(Day 0 (inclusion))
- Titre of antibodies directed against the Monkeypox virus(D7, D14, D28, D43 and M3 after the first injection (D0))
- Cellular immunity to PEP and PrEP vaccination(D0, D10, M3 after the first injection (D0))
- Assess vaccine reactogenicity after each dose of vaccines(up to 1 year after the first injection of PEV)