Sustained Humoral and Cell-Mediated Immunogenicity of COVID-19 Vaccines in Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Evaluation of the immunogenicity of the COVID-19 vaccines by measuring geometric mean titers (GMT) of SARS-CoV-2 antibody concentrations, and quantitative assays to evaluate RBD-binding IgG levels
研究概览
简要总结
The aim of this study is to determine the impact of systemic immunosuppression on sustained antibody COVID-19 concentrations in patients with IBD who received a COVID-19 vaccine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Evaluation of the immunogenicity of the COVID-19 vaccines by measuring geometric mean titers (GMT) of SARS-CoV-2 antibody concentrations, and quantitative assays to evaluate RBD-binding IgG levels
时间窗: 6 and 12 months after third dose of the COVID-19 vaccine, with primary outcome being sustained antibody concentrations at 12 months
Evaluation of the immunogenicity of the COVID-19 vaccines prior to patients receiving a COVID-19 booster during the Fall 2023 through Spring 2024 and at approximately six months after the Fall2023/Spring 2024 COVID-19 booster. Quantitative assays will be used to evaluate RBD-binding IgG levels.
次要结局
- Evaluate the persistence of memory B cell using memory B cell analysis.(during the Fall 2023 through Spring 2024 and at approximately six months after the Fall2023/Spring 2024 COVID-19 booster)
- Sustained cell-mediated immunity against Covid-spike proteins will be evaluated using IFN-ϒ ELISpot, which detects both CD4 and CD8 T cell effectors.(during the Fall 2023 through Spring 2024 and at approximately six months after the Fall2023/Spring 2024 COVID-19 booster)
- Sustained antibody concentration evaluating spike protein and receptor binding(during the Fall 2023 through Spring 2024 and at approximately six months after the Fall2023/Spring 2024 COVID-19 booster)