EUCTR2021-004558-44-NL进行中（未招募）1 期
Optimal Booster Strategy for SARS-CoV-2 Vaccination in Kidney Transplant patients - Recovac booster study
MCG0 个研究点目标入组 460 人开始时间: 2021年9月13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
- 460
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
- •1. Age 18 years or older
- •2. Received 2 doses of mRNA-1273 according to the recommended vaccination schedule, with the last administration within the last nine months
- •3. Insufficient response to vaccination, defined as anti-spike IgG in serum < 10 BAU/mL measured between 25 and 56 days after the second dose of the mRNA-1273 vaccine with a validated test
- •4. Eligible for COVID-19 vaccination as described by the instructions of the manufacturers of the vaccine (Moderna and Janssen)
- •5. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)
- •6. Willing to adhere to the protocol and be available during the study period
- •Additional inclusion criteria to be eligible for stratum A:
- •7. Maintenance immunosuppressive therapy consisting of a calcineurin inhibitor (tacrolimus or cyclosporine), MMF/MPA, and prednisone
- •8. In case of tacrolimus treatment: last tacrolimus pre-dose level while on current dosage above 4 µg/l
- •9. In case of cyclosporine treatment: last cyclosporine pre-dose level while on current dosage above 75 µg/l
- •10. Prednisone dose at least 5 mg/day
- •11. First or second transplantation
- •12. Calculated level of panel reactive antibodies prior to last transplantation below 85%
- •13. No signs of acute rejection during the preceding year
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Multi-organ transplant recipient
- •2. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s).
- •3. Previous or active COVID-19 disease
- •4. Active malignancy, except non-melanoma skin cancer
- •5. Inherited immune deficiency
- •6. Infection with Human Immunodeficiency Virus (HIV)
- •7. Administration of T cell, B cell, or plasma cell depleting antibodies during the last 6 months
- •8. Any vaccination within a month before enrolment
- •9. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
研究者
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