Mass Evaluation of Lateral Flow Immunoassays for the Detection of SARS-CoV-2 Antibody Responses in Immunosuppressed People (The MELODY Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28,411
- 试验地点
- 4
- 主要终点
- The Proportion of Participants With and Without Antibodies to SARS-CoV-2
研究概览
简要总结
DESIGN Observational epidemiological study
AIMS - To determine:
- The proportion of immunosuppressed people who have detectable SARS-CoV-2 antibodies following a primary vaccine course (3 doses), and the demographic, disease, and treatment characteristics that influence antibody status.
- If the detection of antibodies inversely correlates with subsequent risk of severe acute respiratory syndrome coronavirus-2 infection and/or severity of disease in immunosuppressed people.
详细描述
The aim of this proposal is to assess at a population level; 1) the proportion of immunosuppressed people who have detectable SARS-CoV-2 antibodies following a primary vaccine course (3 doses), and the sociodemographic, disease, and treatment characteristics that influence antibody status; 2) if the detection of antibodies inversely correlates with subsequent risk of SARS-CoV2 infection and/or severity of disease in immunosuppressed individuals.
The investigators aim to target patient groups least likely to mount an immune response to vaccination; a) solid organ transplant recipients; b) patients with a rare autoimmune disease c) patients with haematological malignancies, specifically lymphoid malignancies. The investigators will use comprehensive registries to identify and recruit patients from these groups, and utilise the existing linkages these registries already have to obtain COVID-19 outcome information.
The investigators hypothesise that a sizeable proportion of immunosuppressed people will have no detectable SARS-CoV-2 antibodies following a three vaccine doses, and that this cohort is particularly susceptible to SARS-CoV-2 infection and death.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults and young people over 12 years of age, and are classified as being part of one of the following patient groups:
- •A solid organ transplant recipient (n=12,000)
- •Patients with a rare autoimmune disease (n=12,000)
- •Patients with lymphoid malignancies (n=12,000) -
排除标准
- 未提供
结局指标
主要结局
The Proportion of Participants With and Without Antibodies to SARS-CoV-2
时间窗: 21 - 90 days post 4th vaccine
1. The proportion of participants with and without antibodies to SARS-CoV-2 at 21 - 90 days post four vaccine doses will be presented.
The Incidence of Participants Having at Least One RT-qPCR Proven Infection in the 6-month Follow-up Period After 3rd or 4th Vaccine
时间窗: 6-month follow-up period from registration. Reporting of this is delayed following difficulties with collection of data from national bodies.
The incidence of participants having at least one RT-qPCR proven infection in the 6-month follow-up will be presented for those with and without antibodies to SARS-CoV-2 after 3rd or 4th vaccine.
The Incidence of Participants Hospitalised Due to COVID-19 and Deaths Due to COVID-19
时间窗: 6-month follow-up period from registration. Reporting of this is delayed following difficulties with collection of data from national bodies.
The incidence of participants hospitalised due to COVID-19 and deaths due to COVID-19 by 6 months will be presented for those with and without antibodies to SARS-CoV-2 following 3rd or 4th vaccine
Rates of Those With and Without Antibodies to SARS-CoV-2 After 3rd or 4th Vaccine
时间窗: Antibodies at 21 - 90 days after 3rd or 4th vaccine
Rates of those with and without antibodies to SARS-CoV-2 after 3rd or 4th vaccine will be presented for different clinical characteristics and sociodemographic factors.
次要结局
未报告次要终点