Cohort Events Monitoring (CEM) Study for the Assessment of Safety Profile of MVA-BN (Jynneos) Vaccine in Adult Personnel and Staff in the PALM-007 Study in Democratic Republic Of The Congo
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Frequency of AEs After Second MVA-BN Vaccine Dose
研究概览
简要总结
The goal of this observational study is to monitor and assess the safety profile of the MVA-BN vaccine among staff and study personnel of the PALM-007 study in the Democratic Republic of the Congo. The main questions it aims to answer are:
- To estimate the incidence of serious adverse events (SAEs) in all individuals vaccinated with the MVA-BN vaccine
- To estimate the incidence of adverse events (AEs) after each dose of MVA-BN vaccine.
Participants will receive two doses of vaccine and will be actively followed up to the 28th day after their last dose of MVA-BN vaccine.
详细描述
All personnel and staff of the PALM-007 study will be offered the opportunity to participate in the study by reviewing and signing the informed consent. After signing informed consent, participants will be examined. The following parameters will be assessed:
- Anthropometric measurements (weight, height)
- Vital signs: temperature (axillary), blood pressure, heart rate and respiratory rate
- Medical history, including history of orthopox virus disease, vaccination, current co-morbidities and medication(s)
- Physical examination
- Pregnancy test will be done for all women of childbearing potential
If a participant has met all eligibility criteria, they will be enrolled and will receive the vaccine as specified below. Participants who are excluded because of fever can be rescreened and included after resolution of the fever and its cause.
Enrolled participants will receive the MVA-BN vaccine by subcutaneous injection of 0.5 mL in the shoulder (left or right).
The first dose will be administered at the time of enrollment and the second dose 28 days later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Provides written informed consent
- •18 years of age or older
- •At high risk for Monkeypox infections
- •Personnel and staff associated with the PALM 007-Monkeypox study sites in the DRC
- •Willingness and ability to communicate AEs to study personnel
排除标准
- •Allergy to MVA-BN or any of its components
- •Pregnant or breastfeeding women
- •Fever (axillary temperature ≥37.5°celsius)
- •People who have already received the MVA-BN vaccine (in routine vaccination or another study involving this vaccine)
- •Participants who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study
- •Individuals with any condition or circumstance that would render them unable to comply with study procedures (e.g., not reachable by phone)
研究组 & 干预措施
MVA-BN vaccine
2 doses of 0.5 mL MVA-BN vaccine injected subcutaneously and given at least 28 days apart
干预措施: MVA-BN vaccine (Biological)
结局指标
主要结局
Frequency of AEs After Second MVA-BN Vaccine Dose
时间窗: Within 28 days of second vaccine dose
Number of participants with an AE up to 28 days after second vaccine dose
Frequency of SAEs After First Dose of MVA-BN Vaccine
时间窗: Within 14 days of first vaccine dose
Number of participants with an SAE up to 14 days after dose
Frequency of SAEs After Second Dose of MVA-BN Vaccine
时间窗: Within 14 days of second vaccine dose
Number of participants with an SAE up to 14 days after dose
Frequency of AEs After First Dose of MVA-BN Vaccine
时间窗: Within 14 days of first vaccine dose
Number of participants with an AE within 14 days of first vaccine dose
次要结局
未报告次要终点