A Single-centre, Observational Study to Evaluate Immune Response to Covid-19 Vaccines in Immunocompromised Patients With Haematological Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in Anti-SARS-COV2 IgG antibodies in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period
研究概览
简要总结
The UK Medicine and Healthcare products Regulatory Agency (MHRA) granted temporary authorisation to three Covid-19 vaccines in December 2020 and January 2021.
These vaccinations include:
- Covid-19 mRNA BNT162b2 vaccine (Pfizer-BioNtech vaccine);
- ChAdOx1-S vaccine (Astra Zeneca vaccine);
- Covid-19 mRNA vaccine (Moderna vaccine).
Any other Covid-19 vaccines approved for use by the MHRA in immunocompromised and immunocompetent patients are to be included in this study. The above vaccines have received temporary authorisation after placebo-controlled phase 3 studies confirmed their safety and efficacy in over 100,000 volunteers. People who were immunocompromised or were receiving chemotherapy, radiotherapy or immunoglobulin treatment were excluded from these studies. Safety, efficacy, and durability of antibody response in these studies has been assessed for up to 14 weeks only. These vaccines are being rolled out in the UK and have been recommended for use for immunosuppressed individuals including patients undergoing chemotherapy, immunotherapy, radiotherapy, and those who have undergone stem cell transplantation. Though the MHRA has approved vaccination for immunocompromised patients there is no published evidence to confirm safety and efficacy in these patients. The durability of antibody response and whether this is affected by concurrent chemotherapy, immunotherapy, radiotherapy treatment is also unknown.
This observational study aims to evaluate the immune response to Covid-19 vaccines in haematology patients who have immune suppression either due to disease, treatment, or both. The investigators plan to measure Anti-SARS-COV2 IgG antibody levels at 3-5 time points 30 days apart after patients have received their 2nd dose of Covid-19 vaccine. The investigators will also collect any adverse events reported by patient including Covid-19 infection or disease after vaccination.
The study plans to recruit 50 haematology patients who are clinically assessed by a haematologist as immunosuppressed due to their disease, treatment, or both. The study also plans to recruit 30 healthy (immunocompetent) volunteers who would be the control group for comparison of antibody response and durability.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Anti-SARS-COV2 IgG antibodies in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period
时间窗: Nearest 30 day time point after 2nd dose Covid-19 vaccination (baseline) and every 30 days (3-5 follow-up time points) after 2nd dose of Covid-19 vaccination (+/- 7 days)
Anti-SARS-COV2 IgG antibodies
Duration of Anti-SARS-COV2 IgG antibody response in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period
时间窗: 120 days follow-up (+/- 7 days) - optional
Duration of Anti-SARS-COV2 IgG antibody response
次要结局
- Correlation in antibody response with patient Covid-19 vaccine type(From recruitment until up to 120 days follow-up (+/- 7 days))
- Correlation in antibody response with patient haematological disorder(From recruitment until up to 120 days follow-up (+/- 7 days))
- Correlation in antibody response with patient treatment(From recruitment until up to 120 days follow-up (+/- 7 days))
- Correlation in antibody response with patient pre-vaccine immunological parameters(From recruitment until up to 120 days follow-up (+/- 7 days))
- Correlation in antibody response with patient gender(From recruitment until up to 120 days follow-up (+/- 7 days))
- Correlation in antibody response with patient ethnicity(From recruitment until up to 120 days follow-up (+/- 7 days))
- T-Cell response after second dose Covid-19 vaccination in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period(From recruitment and at 60 or 90 days follow-up (+/- 7 days))
- Correlation in antibody response with patient age(From recruitment until up to 120 days follow-up (+/- 7 days))
- Duration of T-Cell response after second dose Covid-19 vaccination in immunocompromised haematology patients compared to immunocompetent controls over a 4 month period(From recruitment and at 60 or 90 days follow-up (+/- 7 days))
- PCR positive Covid-19 infections reported by the study group and control group(From recruitment until up to 120 days follow-up (+/- 7 days, as reported during this time frame))
- Adverse events associated with the first and second dose of a Covid-19 vaccination, reported by the study group and control group(From recruitment until up to 120 days follow-up (+/- 7 days))