Efficacy and Safety of COVID-19 Vaccine in Patients After Allogeneic Hamatopoietic Cell Transplantation, CAR-T Therapy and With Primary Immune Deficiency - a Post Marketing Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Incidence of side effects in patients
研究概览
简要总结
The corona pandemic is a continuing global challenge due to Corona Virus 2019 (COVID-19).
The purpose of the study is to confirm the accepted hypothesis from the recommendations of The European Society for Blood and Marrow Transplantation, that the vaccine for COVID-19 is safe and has good efficacy in immunocompromised patients after a bone marrow transplant from a donor / cellular therapy.
详细描述
The study population will be allogeneic bone marrow transplant patients and those who have received CART therapy - immunocompromised patients who are vaccinated with COVID-19 in a commercial preparation, regardless of the study.
The following procedures are routinely performed before receiving the vaccine in the bone marrow transplant unit -
- Blood count and lymphocyte subgroup counts before vaccination (up to 48 hours before vaccination).
- Evaluation of GVHD activity and accompanying toxicity.
- Receipt of a letter confirming the vaccination to the HMO.
- One-week follow-up after vaccination including blood count, complete chemistry, GVHD evaluation, and review of adverse reactions that may be vaccine-related.
- Referral for a second dose of the vaccine.
- One week follow-up after vaccination including blood count, complete chemistry, GVHD evaluation, review of side effects that may be vaccine related.
The following procedures are performed only as part of the study -
- Serology test (IgG AntiS) two weeks after the second dose of the vaccine to test the effectiveness of the vaccine.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients aged 18 and over
- •Patient sex - male and female
- •Bone marrow transplant from a donor (sibling or unrelated) or after cell therapy (CART) at least 3 months before vaccination.
- •Patients with primary immunodeficiency syndrome.
- •Patients who are able to sign an informed consent form
排除标准
- •Patients under 18 years of age
- •Patients who are unable to give informed consent
- •Patients with acute GVHD who require steroid therapy above 0.5 mg / kg or who have been diagnosed in the last month.
- •Patients with chronic GVHD who require steroid therapy above 0.5 mg / kg
- •Patients treated with rituximab / immunoglobulins / mesenchymal cells during the last month.
- •Patients whose disease is not completely cured and receive dedicated treatment for the disease.
- •Patients receiving maintenance treatment for the underlying disease (excluding TKIs such as sorfenib, midostaurin, guiltritinib or cranolinib).
- •Patients who have previously had COVID
- •Patients with severe allergy to one of the vaccine components.
结局指标
主要结局
Incidence of side effects in patients
时间窗: 10 weeks counting since first vaccination is initiated.
Incidence of side effects in patients post allogeneic bone marrow transplantation after COVID-19 vaccination
次要结局
- Prevalence of severe adverse reactions(10 weeks counting since first vaccination is initiated.)