A Phase IV Vaccine Study Under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2 (COVID-19) Vaccines (ENFORCE PLUS)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 5
- 主要终点
- Assessment of the J& J vaccine
研究概览
简要总结
A phase IV study to assess if the SARS-CoV-2 vaccine from Johnson & Johnson/Janssen (J&J) results in change in number and activation of platelets and anti-PF4 Level. As well as compare whether the vaccine is causing a greater activation of platelets and anti-PF4 than the mRNA vaccines.
The Danish Medicines Agency has approved the vaccine from J&J for use in Denmark, however it is not currently part of the national vaccine programme.
The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls. A sub-study will be embedded within this master protocol addressing basic and translational research questions requiring additional sampling of biological material (under separate participant informed consent).
详细描述
Participants will have 3 specific study visits and will hereafter be followed for 2 years after the vaccination with regular visits after 3, 6, 12 and 24 month. In this way the participants will be offered an extra close follow up on vaccine effectiveness.
Safety data will be collected at study visits until 3 months after the first vaccination,, with additional safety data collected under this protocol during the first month after vaccination.
Research samples will be collected at each study visit during the two-year follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Written informed consent obtained before any trial related procedures are performed
- •Male or female eligible for SARS-CoV-2 immunization (as defined by SST in the 'Tilvalgsordningen')
- •The subject must be willing and able to comply with trial protocol (re-visits and biological samples)
排除标准
- •Male and female under the age of 18
- •Any subgroup of individuals for which the vaccine is contra-indicated
- •Previous SARS-CoV-2 vaccination
- •Specific for the Johnson & Johnson vaccine:
- •Experience of a serious allergic reaction after injection of any other vaccine
- •Serious infection with high fever (> 38 0C) A temporary postponement of the vaccination is allowed, when participant has been well for at least 48 hours. Mild fever or upper airway infection like a cold is not a problem
- •Problems with bleeding or bruising, or use of anticoagulant medicine (to prevent blood clots)
- •Immunodeficiency or use of medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants or cancer medicines)
研究组 & 干预措施
Vaccine Johnson and Johnson/Janssen Covid-19 vaccine
Johnson & Johnson/Janssen Covid-19 vaccine.
干预措施: Johnson & Johnson (Biological)
结局指标
主要结局
Assessment of the J& J vaccine
时间窗: The change from base-line to after 24 month
To clarify whether vaccination with the J\&J vaccine leads to changes in the number and activation of platelets as well as anti-PF4 level and to compare whether the J\&J vaccine causes a stronger activation of platelets as well as an increase in anti-PF4 antibodies compared to mRNA vaccines. Included is also questionnaires
次要结局
未报告次要终点
研究者
Jens D Lundgren, MD
Professor
Rigshospitalet, Denmark