Registry Study for COVID19 Vaccination Efficacy in Patients With a Treatment History of Rituximab.
试验速览
- 阶段
- 不适用
- 入组人数
- 425
- 试验地点
- 1
- 主要终点
- Humoral immune response to SARS-CoV2 spike protein
研究概览
简要总结
Patients with treatment history of rituximab since 01.01.2019 and immunocompetent volunteers will be contacted to give a blood sample after their COVID19 vaccination, and in a subset also before vaccination. Immune responses of antibodies and SARS-CoV2-specific T-cells to the vaccination will be quantified and the rituximab effect on COVID19 vaccine-induced immune responses is analyzed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who were treated with anti-CD20 treatment since 01.01.2010
- •Patients who received a COVID19 vaccination (completion of all required doses) until target date (initial target: 30.05.21, but can be delayed to 30.06.21, 30.07.21 or 30.08.21 in case of insufficient enrollment)
- •Volunteers without a history of anti-CD20 treatment exposure
- •All: written informed consent.
排除标准
- •Exclusion criteria for patients (any of the following)
- •Patients aged 18 years and younger at time of study enrollment and/or
- •Pregnant or lactating women at time of study enrollment and/or
- •Patients who do not provide written informed consent and/or
- •Patients who have previously had a COVID19 infection (self-reported COVID19 disease, positive PCR or serology)
- •Patients who are in a dependency relationship with the study personnel (hierarchical, social)
- •Exclusion criteria for volunteers (any of the following)
- •Volunteers aged 18 years and younger at time of study enrollment and/or
- •Pregnant or lactating women at time of study enrollment and/or
- •Volunteers who do not provide informed consent and/or
- •Volunteers who suffer from an active autoimmune disease, active cancer, immunosuppressive therapy, history of anti-CD20 treatment and/or
- •Volunteers who have previously had a COVID19 infection (self-reported COVID19 disease, positive PCR or serology)
- •Volunteers who did not complete their COVID19 vaccination
- •Volunteers who are in a dependency relationship with the study personnel (hierarchical, social)
研究组 & 干预措施
Immunocompetent controls
Participants aged at least 18 years, no history of COVID19, no history of anti-CD20 treatment
干预措施: Completion of COVID19 vaccine at least 4 weeks ago (Biological)
Patients with a treatment history of rituximab
Participants aged at least 18 years, no history of COVID19, history of at least 1 dose of anti-CD20 treatment received since 01/01/2010
干预措施: History of exposure to anti-CD20 treatment since 01/01/2010 (Drug)
Patients with a treatment history of rituximab
Participants aged at least 18 years, no history of COVID19, history of at least 1 dose of anti-CD20 treatment received since 01/01/2010
干预措施: Completion of COVID19 vaccine at least 4 weeks ago (Biological)
结局指标
主要结局
Humoral immune response to SARS-CoV2 spike protein
时间窗: At least 4 weeks after completion of COVID19 vaccination
Percentage of all patients developing IgG antibodies against SARS-CoV2 spike protein that is comparable to the immunological response in immunocompetent controls (-2 standard deviations of mean)
次要结局
- Correlation between IgG antibodies against SARS-CoV2 and B-cell counts, T-cell counts and total immunoglobulin levels(At least 4 weeks after completion of COVID19 vaccination)
- Correlation of IgG antibodies against SARS-CoV2 with age, history, co-medication and biomarkers of immunocompetence(At least 4 weeks after completion of COVID19 vaccination)
- Correlation of IgG antibodies against SARS-CoV2 with time interval since last dose of rituximab(At least 4 weeks after completion of COVID19 vaccination)
- Correlation of IgG antibodies against SARS-CoV2 with cumulative dose of rituximab received.(At least 4 weeks after completion of COVID19 vaccination)
- T cell anti-SARS-CoV2 response after COVID19 vaccination(At least 4 weeks after completion of COVID19 vaccination)