A Norwegian Study of Vaccine Response to COVID-19 Vaccines in Patients Using Immunosuppressive Medication Within Rheumatology and Gastroenterology: the Nor-vaC Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,300
- 试验地点
- 2
- 主要终点
- Serological response
研究概览
简要总结
The purpose of this study is to assess the strength and duration of the immunological response to COVID-19 vaccines in patients treated with immunosuppressive and/or immunomodulating medication for immune-mediated inflammatory diseases in rheumatology and gastroenterology and after a liver transplantation.
详细描述
Patients on long-term immunosuppressive and/or immunomodulating medication may be susceptible to serious COVID-19. Hence, it is important they get sufficient protection by a COVID-19 vaccine. However, these patients may also be at risk for a less robust vaccine response. There is an urgent need to assess the humoral and cellular immune response to COVID-19 vaccines in these patient groups. The clinical consequences could be to administer several re-vaccinations or to adjust medication. This prospective, observational study aims to assess the immune response after COVID vaccination in patients suffering from inflammatory diseases and using immunosuppressive medication. Also, liver transplanted patients on immunosuppressive medication will be included.
Serum and whole blood samples will be obtained from all participants before and 1-4 weeks after the vaccination. Additionally, serum samples will be collected every 3-6 months for 5 years. If patients are allotted further vaccine doses , the patient response will be assessed by blood tests 2-4 weeks after any additional vaccine doses. In a subset of patients, samples will be drawn to study cellular immune responses. Demographic data and data regarding immunosuppressive medication will be recorded. Disease activity (clinical activity indices and biomarkers of inflammation) will be assessed. Blood samples will be obtained for biobank. Information regarding vaccination status and potential COVID-19 testing will be obtained from relevant registers.
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
- 否
入选标准
- •An established clinical diagnosis of one of the following immune-mediated diseases: rheumatoid arthritis (RA), spondyloarthritis (SpA), psoriatic arthritis (PsA), ulcerative colitis (UC,) Crohns disease (CD), autoimmune hepatitis (AIH) or patients who have undergone a liver transplantation
- •Treatment with relevant immunosuppressive and/or immunomodulating medication *
- •Adult patients (> 18 years)
- •Patient intends to obtain vaccination against COVID-19 during the next 6 months
- •* The following drugs are considered relevant immunosuppressants and/or immunomodulators and patients using them may be eligible for this study: Rituximab, infliximab, adalimumab, golimumab, certolizumab, etanercept, tocilizumab, abatacept, secukinumab, vedolizumab, ustekinumab, risankizumab, methotrexate, sulfasalazine, leflunomide, azathioprine, 6-mercaptopurine, tofacitinib, filgotinib, baricitinib, upadacitinib, tacrolimus, mycophenolate, prednisolone
排除标准
- •Allergy or intolerance to elements of the COVID-19 vaccines
结局指标
主要结局
Serological response
时间窗: 4 weeks after vaccination, then at 3 month intervals during the first year and 6 month intervals for up to a total of 5 years
Change from baseline in serum levels of anti-SARS-CoV-2 antibodies
次要结局
- BASDAI(Within 4 weeks of the patient receiving the final dose of vaccine)
- Harvey-Bradshaw index (HBI)(Every 3 months for the first year of study, every 6 months thereafter until study completion)
- DAS28(Within 4 weeks of the patient receiving the final dose of vaccine)
- Cellular response(7-10 days after vaccination, then at 3 month intervals during the first year and 6 month intervals for up to a total of 5 years)
- Partial Mayo score(Every 3 months for the first year of study, every 6 months thereafter until study completion)
- Adverse events(Reported by patient for the first 48 hours following each vaccine dose)
研究者
Guro Løvik Goll
Principal investigator
Diakonhjemmet Hospital