Convalescent Plasma Donor Vaccine Study: An Observational Antibody Level Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Increase in antibody levels post-vaccination assessed via Roche IgG assay
研究概览
简要总结
There is a need to understand antibody responses following SARS-COV-2 infection and subsequent vaccination.
详细描述
This is an observational study to determine changes in antibody levels in individuals who have previously donated COVID-19 convalescent plasma (CCP) and have now received at least one dose of a COVID-19 vaccine. At present these donors could no longer donate CCP as their virus-neutralising antibody levels do not reach the level required (Euroimmun of at least 6 IgG signal/control cutoff).
Two blood samples (9 ml total) will be collected at a local NHSBT donor centre to test the levels of the virus-neutralising antibodies in the plasma against different viral strains.
The results of this study will:
- Determine whether NHSBT will collect CCP or plasma for medicines (PFM) from vaccinated members of the public that could have boosted antibody levels following vaccine administration.
- Understand if antibody levels rebound to a concentration suitable for CCP and PFM.
- Provide the evidence to support the use of CCP for the early treatment in COVID (currently under consideration as a collaboration with European partners).
- Assist in development of recording vaccination status on NHSBT databases of donors.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 17 Years 至 66 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who have had a previous SARS-CoV-2 infection
- •Individuals who have previously donated COVID-19 convalescent plasma (CCP)
- •Received at least one dose of a SARS-CoV-2 vaccine (any type of vaccine)
排除标准
- •Not received a SARS-CoV-2 vaccine
结局指标
主要结局
Increase in antibody levels post-vaccination assessed via Roche IgG assay
时间窗: at least 28 days following vaccination
Roche IgG assay
Increase in antibody levels post-vaccination assessed vial live virus neutralization
时间窗: at least 28 days following vaccination
Live virus neutralization (SARS-CoV-2 wild type (WT), alpha,beta and delta variants)
Increase in antibody levels post-vaccination assessed via Euroimmun assay
时间窗: at least 28 days following vaccination
Euroimmun assay
次要结局
未报告次要终点
研究者
Lise Jane Estcourt
Haematologist Consultant
NHS Blood and Transplant