NL-OMON50602已完成3 期
Optimal Booster Strategy for SARS-CoV-2 Vaccination in Kidney Transplant patients - Recovac Booster Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
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. Capable of understanding the purpose and risks of the study, fully informed
- •and given written informed consent (signed informed consent form has been
- •Additional inclusion criteria to be eligible for stratum A:
- •5. Maintenance immunosuppressive therapy consisting of a calcineurin inhibitor
- •(tacrolimus or cyclosporine), MMF/MPA, and prednisone
- •6. In case of tacrolimus treatment: last tacrolimus pre-dose level while on
- •current dosage above 4 *g/l
- •7. In case of cyclosporine treatment: last cyclosporine pre-dose level while on
- •current dosage above 75 *g/l
- •8. Prednisone dose at least 5 mg/day
- •9. First or second transplantation
- •10. Calculated level of panel reactive antibodies prior to last transplantation
- •11. No signs of acute rejection during the preceding year
排除标准
- •1. Multi-organ transplant recipient
- •2. Previous or active COVID-19 disease
- •3. Active malignancy, except non-melanoma skin cancer
- •4. Inherited immune deficiency
- •5. Infection with Human Immunodeficiency Virus (HIV)
- •6. Administration of T cell, B cell, or plasma cell depleting antibodies during
- •the last 6 months
- •7. Any vaccination within a month before enrolment
研究者
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Optimal Booster Strategy for SARS-CoV-2 Vaccination in Kidney Transplant patientsCOVID-19 is associated with severely increased morbidity and mortality in kidney transplant patients. Available data show that the immune response after a standard regimen of two mRNA vaccinations is severely attenuated in kidney transplant patients compared to controls, especially when their immunosuppressive regimen contains mycophenolate mofetil (MMF) / mycophenolic acid (MPA).MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862MedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 100000004865MedDRA version: 23.1Level: LLTClassification code 10084465Term: COVID-19 vaccinationSystem Organ Class: 100000004865MedDRA version: 23.1Level: LLTClassification code 10084508Term: COVID-19 antibody testSystem Organ Class: 10022891 - InvestigationsMedDRA version: 20.0Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 20.0Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 100000004865MedDRA version: 23.0Level: LLTClassification code 10084270Term: SARS-CoV-2 acute respiratory diseaseSystem Organ Class: 100000004862MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862MedDRA version: 23.0Level: LLTClassification code 10084462Term: SARS-CoV-2 vaccinationSystem Organ Class: 100000004865MedDRA version: 23.0Level: LLTClassification code 10084463Term: SARS-CoV-2 immunisationSystem Organ Class: 100000004865MedDRA version: 23.0Level: LLTClassification code 10084466Term: SARS-CoV-2 immunizationSystem Organ Class: 100000004865MedDRA version: 23.1Level: PTClassification code 10084501Term: SARS-CoV-2 antibody testSystem Organ Class: 10022891 - InvestigationsEUCTR2021-004558-44-NLMCG460
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