NL-OMON51214已完成不适用
Immune responses Induced by Vaccination Against COVID-19 in Dutch healthy subjects - IIVAC
Ministerie van Volksgezondheid, Welzijn en Sport (VWS)0 个研究点目标入组 1,459 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,459
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0 至 64（—）
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
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 ref.) that this study provides a comparison for:
- •o Primary (inherited) immune deficiency (VACOPID study)
- •o Severely 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)
- •o Pulmonary disease for which the patient will receive or has received a lung
- •transplant (COVALENT study)
- •o Autoimmune disease (e.g. MS, rheumatoid arthritis, IBD, SLE etc) (Target to
- •B! (sub)study)
- •o Down syndrome (PRIDE study)
- •o (Known) infection with Human Immunodeficiency Virus (HIV) (COVIH study)
- •o Cancer 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)
- •o Haematological 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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