EUCTR2021-001040-10-AT进行中（未招募）1 期
Humoral and cellular immune response to COVID-19 vaccines in immunocompromised and healthy individuals – The CoVVac study - The CoVVac study
Medical University of Graz0 个研究点目标入组 390 人开始时间: 2021年3月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 390
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
- •In order to be enrolled, participants must be 18 years or older, able to understand study procedures, provide written informed consent (Biobank informed consent and study specific informed consent), and meet one of the following inclusion criteria:
- •1.Noninfectious immunocompetent participants (i.e., healthy participants) as determined by medical history and clinical judgement.
- •2.Patients with primary immunodeficiencies
- •3.Patients with B-cell depleting therapy due autoimmune disease
- •4.Patients with benign and malignant hematological diseases receiving specific treatments with known immunosuppressive effects including cytotoxic agents, systemic corticosteroids, monoclonal antibodies and targeted therapies.
- •5.Patients with active hematological diseases and secondary immunoglobulin deficiency (e.g. CLL, MM) currently not receiving specific treatment.
- •6.Patients >3 months but <12 months after autologous HSCT.
- •7.Patients >3 months but <12 months after allogeneic HSCT.
- •8.Recipients of HSCT >12 months after allogeneic HSCT but under immunosuppressive therapy.
- •9.Patients with chronic GvHD and persistent immunodeficiency.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 195
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 195
排除标准
- •Subjects meeting any of the following criteria cannot be enrolled into the trial:
- •Healthy participants
- •1.Presence of diseases or therapies that are likely to interfere with the immune response to vaccination.
- •2.Presence of a disease requiring change in therapy during 4 weeks before enrollment.
- •3.Any contraindications to the vaccine planned to receive as listed in the product characteristics.
- •4.Lack of willingness to undergo serial blood draws and attend follow-up appointments.
- •5.Women who are pregnant or breastfeeding.
- •6.Previous vaccination with any coronavirus vaccine.
- •7.Persons who are not willing to sign the informed consents (biobank informed consent and study specific informed consent).
- •Immunodeficient participants
- •1.Patients with hematological diseases within three months from B-cell-depleting immunotherapy (rituximab, ofatumumab, obinutuzumab, blinatumomab, CAR-T cells).
- •2.Patients with hematological malignancies in remission and >12 months after end of specific therapy.
- •3.Patients within three months from HSCT.
- •4.Any contraindications to the vaccine planned to receive as listed in the product characteristics.
- •5.Lack of willingness to undergo serial blood draws and attend follow-up appointments.
- •6.Women who are pregnant or breastfeeding.
- •7.Previous vaccination with any coronavirus vaccine (exception: if serum prior to vaccination is available from the biobank).
- •8.Patients who are not willing to sign the informed consents (biobank informed consent and study specific informed consent).
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