Immunological Response to COVID-19 Vaccine in Patients With Autoimmune and Inflammatory Diseases Treated With Immunosuppressants and/or Biologics
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Proportion of patients with neutralizing antibody
研究概览
简要总结
Vaccination against the new coronavirus (SARS-CoV-2) was extended to patients at risk of severe forms of Covid-19, including in particular patients with autoimmune and inflammatory diseases treated by immunosuppressants and/or biologics.
In this particular population, the effectiveness of vaccines, in particular influenza and pneumococcal vaccinations, is often reduced, especially in case of treatment with rituximab and / or methotrexate.
Regarding the SARS-CoV-2 vaccine, the studies that allowed the marketing authorization of the available vaccines did not include patients treated with immunosuppressants or immunomodulators.
Thus, the impact of treatments on the production of neutralizing antibodies and specific T lymphocytes is not known.
The goal of this study is to assess the immune response to the SARS-CoV-2 vaccine in patients with autoimmune and inflammatory diseases treated with immunosuppressants or immunomodulators.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 否
入选标准
- •Group 1 :
- •Patient over 18 years old,
- •Patient informed and not opposed to participate
- •Patient followed for an autoimmune or inflammatory disease (vasculitis, systemic lupus, systemic sclerosis, non-infectious uveitis)
- •Treatment with immunosuppressant and / or immunomodulator
- •Group 2 :
- •Patient over 18 years old,
- •Patient informed and not opposed to participate
- •Patient not followed for an autoimmune or inflammatory disease (vasculitis, systemic lupus, systemic sclerosis, non-infectious uveitis)
- •Absence of treatment with immunosuppressant and / or immunomodulator
排除标准
- •Contraindication to vaccination
- •Progressive cancer
- •Pregnant or breastfeeding woman
- •Current infection less than 3 weeks old
- •Weight less than 40 kg
- •Patient under tutor- or curator-ship
- •Patient without health insurance
研究组 & 干预措施
Patients with auto-immune or autoinflammatory diseases
Patients with auto-immune or autoinflammatory diseases treated with immunosuppressants and/or biologics
干预措施: Blood sample (Biological)
Patients without auto-immune or autoinflammatory diseases
Patients without auto-immune or autoinflammatory diseases and not treated with immunosuppressants and/or biologics
干预措施: Blood sample (Biological)
结局指标
主要结局
Proportion of patients with neutralizing antibody
时间窗: 1 month after vaccination
次要结局
- Proportion of patients with symptomatic infection by Covid 19 during follow-up(12 months after vaccination)
- Proportion of patients with treatment-related adverse events grade 3 or 4(12 months after vaccination)
- Proportion of patients with anti-SARS-CoV2 specific T lymphocytes(12 months after vaccination)
- Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment(12 months after vaccination)
- Proportion of patients with flair of autoimmune disease(12 months after vaccination)
- Proportion of patients with neutralizing antibody(12 months after vaccination)