Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases
试验速览
- 阶段
- 不适用
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- vaccine efficacy in IBD population
研究概览
简要总结
The 2019-coronavirus disease (COVID-19), caused by SARS-CoV-2, was identified as the source of pneumonia cases in Wuhan city in China. It rapidly spread worldwide and was declared by WHO as a pandemic. COVID-19 vaccines are expected to be the breakthrough in controlling the pandemic. However, studies performed only in healthy adults, and specifically excluded patients who were under immunomodulatory/biologic therapy, thus excluding patients with chronic inflammatory diseases (IBD). In this study we wish to understand vaccine efficacy and immunological response in IBD patients.
详细描述
Overall Aims:
- To assess the immune response to COVID-19 vaccination in patients with IBD.
- Comparing the short and long term immune response to vaccination among subgroups receiving different therapies.
- To evaluate the different variables affecting immunity of these patients.
- To assess adverse reactions to COVID-19 vaccines and IBD related complications.
Specifically:
-
To assess serologic response to COVID-19 vaccine(s) in patients with IBD treated with anti-TNF agents (+/- immunomodulators) compared to
-
Healthy controls
-
Patients with IBD not treated with anti-TNF (+/- immunomodulators)
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To characterize serologic response: seroconversion, seroprotection and persistence of COVID-19 vaccine(s) in patients with IBD
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To identify factors associated with serologic response
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Side effects to vaccines
-
IBD exacerbation compared to activity at baseline
-
Symptomatic COVID-19
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults >18 years of age
- •Patients with either Crohn's disease, ulcerative colitis, ileostomy, pouch
- •Not vaccinated to COVID-19 [i.e. before 2 mRNA Pfizer vaccines provided, or before any vaccine provided as one injection
- •Ability to attend follow up visits
- •Ability to understand and sign an informed consent form
排除标准
- •Pregnant women
结局指标
主要结局
vaccine efficacy in IBD population
时间窗: 4 weeks post second COVID-19 vaccine.
• Efficacy of the vaccination for IBD patients compared to the normal population measured as proportion of patients achieving positive serology
次要结局
- Immunologic assessments affect response to vaccine(12 months)
- Therapy related variants affect immunological response(12 months)
- Disease related variant affect immunological response(12 months)
- Adverse Events to covid-19 vaccine(12 months)
研究者
IRIS DOTAN
Head of Gasteroenterology Division
Rabin Medical Center