Investigation of the Immune Response Before and After COVID-19 Disease or SARS-CoV-2 Vaccination in Dialysis Patients, Solid Organ Recipients and Medical Staff
试验速览
- 阶段
- 不适用
- 入组人数
- 3,500
- 试验地点
- 1
- 主要终点
- Immune response to SARS-CoV-2 infection or vaccination
研究概览
简要总结
To investigate short- (3 and 8 weeks) and long-term (6, 9, 12, and 18 months) immune protection or response at the humoral and cellular levels before and after SARS-CoV-2 infection or vaccination in patients with moderately reduced immune status (dialysis patients) and severely reduced immune status (organ transplant recipients, mostly kidney transplant recipients) and immunocompetent subjects (medical staff) in Saxony, Germany.
详细描述
- Formation of two separate cohorts of approximately 1000 study subjects each from the three categories (dialysis patients, solid organ transplant recipients and medical staff) of participants vaccinated using either Biontech or Moderna vaccine (Biontech cohort and Moderna cohort, approximately 2000 subjects total).
- Study time points: Before administration of the 1st SARS-CoV-2 vaccine dose, before the 2nd vaccine dose, and 8 weeks and 6, 9, 12, and 18 months after administration of the 1st vaccine dose and after suspected or proven SARS-CoV-2 infection.
- At all time points, a questionnaire or eCRF will be completed with questions about the dialysis center and the clinical course of the patients.
- Humoral immune response will be determined in all study participants.
- Formation of a study subgroup of up to 300 subjects in each cohort (Biontech or Moderna cohort) for detailed evaluation of the cellular immune response (max. 600 subjects in total).
- In case of non-sustained immunity > 6 months as well as the occurrence of a 3rd SARS-CoV-2 infection wave in autumn 2021, this will be investigated analogously to the current wave.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dialysis patients, organ transplant recipients and medical staff
- •written consent to participate in the study
排除标准
- •Age < 18 years old
结局指标
主要结局
Immune response to SARS-CoV-2 infection or vaccination
时间窗: 24 months after vaccination or infection
Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection
Humoral response to SARS-CoV-2 infection or vaccination
时间窗: 24 months after infection or vaccination
SARS-CoV-2 IgA, IgM and different IgG antibody levels
Cellular response to SARS-CoV-2 infection or vaccination
时间窗: 24 months after infection or vaccination
T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).
次要结局
- Effectiveness of vaccination on severity and incidence of COVID-19(24 months after vaccination or infection)
- SARS-CoV-2 infection or immune response to vaccination(24 months after infection or vaccination)
- Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease(24 months after vaccination)
- Compare vaccination effect in different vaccinations and risk populations(24 months after vaccination)
- Protection of re-boostering if necessary(24 months after re-boostering)
- Strength of immune response(24 months after infection or vaccination)
- SARS-CoV-2 vaccination side effects(24 months after vaccination)
- Duration of vaccination effect(24 months after vaccination)
- SARS-CoV-2 incidence and prevalence(24 months after infection or vaccination)
研究者
Susanne Dollfus
Prof. Dr. med. Christian Hugo
Technische Universität Dresden