EUCTR2021-001357-31-NL进行中（未招募）1 期
Immune Responses Induced by Vaccination Against COVID-19 in Dutch healthy subjects - IIVAC
ational Institute of Health and the Environment0 个研究点目标入组 2,100 人开始时间: 2021年4月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Be 0 – 60 years at the time of inclusion
- •Be capacitated mentally and physically
- •Be willing to receive SARS-CoV-2 vaccine
- •Having signed the Informed Consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 300
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1800
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Participation in a phase I/II/III vaccination trial where the subject will be vaccinated with a pre-registration (COVID-19) vaccine
- •Participation in a phase I/II/III medicine (pre-registration) trial
- •Belonging to a risk group for COVID-19 that is studied in one of the ZonMw-funded risk group vaccination studies (details of risk group studies provided in protocol ref. [9,10,11]) that this study provides a comparison for:
- •oPrimary (inherited) immune deficiency (VACOPID study)
- •oSeverely decreased kidney function (defined as Chronic Kidney Disease stage 4 or 5 (eGFR<30)), treatment by dialysis or recipient of a kidney transplant (RECOVAC study)
- •oPulmonary disease for which the patient will receive or has received a lung transplant (COVALENT study)
- •oAutoimmune disease (e.g. MS, rheumatoid arthritis, IBD, SLE etc) (Target to B! (sub)study)
- •oDown syndrome (PRIDE study)
- •o(Known) infection with Human Immunodeficiency Virus (HIV) (COVIH study)
- •oCancer patients and patients with active cancer treatment (including hormone therapy), receipt of chemotherapy in the last 3 years and/or any history of cancer immune therapy (VOICE study)
- •oHaematological patients, such as haematological malignancies (leukemia and lymphomas), myelodysplastic and -proliferative syndromes, hemoglobinopathies (sickle cell disease and thalassemia), receipt of stem cell transplantation or cell therapy such as CAR T-cell therapy (COBRA-KAI study)
- •Any other immune deficiency through disease
- •Active or past immunosuppressive or immune modulating medication.
- •However, for steroid treatment the exclusion criteria are: receipt of any high-dose (= 20 mg of prednisone daily or equivalent) steroid treatment; daily corticosteroids (locally, incl. inhaled steroids, are acceptable) within 2 weeks of study entry; or repeated use of any high dose of corticosteroids (a dose of > 30 mg of prednisone or equivalent per day for multiple days) in the recent past.
- •Women who are pregnant or breastfeeding
- •Having a (functional) asplenia
- •Receipt of blood products or immunoglobulin, within 3 months of study entry
- •Receipt of an organ transplant not mentioned above
- •For the subgroup: Known or suspected coagulation disorder, also by treatment, that would contraindicate undergoing frequent blood sampling
研究者
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