A Multi-Centre 12 Month Parallel-Group Randomized Control Trial of BNT162b2 Versus mRNA( Messenger Ribonucleic Acid) -1273 COVID-19 Vaccine Boosters in Chronic Kidney Disease and Dialysis Patients With Poor Humoral Response Following COVID-19 ( Corona Virus Disease of 2019)Vaccination
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 273
- 试验地点
- 3
- 主要终点
- Serum Level of Anti-RBD ( Anti Receptor Binding Domain )
研究概览
简要总结
This study is a 12-month, four-arm parallel-group randomized control trial of Pfizer-BioNTech versus MODERNA COVID-19 (Corona Virus disease 2019)vaccine boosters in chronic kidney disease and dialysis patients with poor humoral response following COVID-19 vaccination, in collaboration with 5 dialysis centers in Ontario and British Columbia, Canada .
Patients will be randomized to MODERNA or Pfizer-BioNTech COVID-19 vaccine, they may have received either MODERNA or Pfizer-BioNTech COVID-19 vaccine for their initial two doses of vaccine, and will be stratified by their initial vaccine type (MODERNA or Pfizer-BioNTech ) prior to randomization, which will result in four study groups.
详细描述
MODERNA : Nucleocapsid Modified messenger RNA BioNTech: Bio-Pharma new Technology
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
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 with Chronic Kidney Disease (CKD)stage 3b-5 defined as an eGFR( estimated glomerular filtration rate ) of less than 45ml/min/1.73m2 or less will be eligible. Stage 5 CKD will include patients receiving in-center hemodialysis, home dialysis (home hemodialysis or peritoneal dialysis), vaccinated with two doses of the COVID-19 vaccine will be eligible for a third dose to be given 2-12 months following the second dose.
- •Age ≥18 at the time of study enrolment
排除标准
- •Patients not vaccinated against COVID-19 vaccination.
- •Patients who received heterologous first two doses of vaccine
- •Patients with a severe allergic reaction to prior COVID-19 vaccination or any of the ingredients.
- •New COVID-19 infection
研究组 & 干预措施
Patients who received two doses Pfizer-BioNTech vaccine, Arm 1
干预措施: Pfizer-BioNTech COVID-19 Vaccine (Biological)
Patients who received two doses MODERNA vaccine, Arm 2
干预措施: Pfizer-BioNTech COVID-19 Vaccine (Biological)
Patients who received two doses Pfizer-BioNTech vaccine ,Arm 3
干预措施: MODERNA SARS-CoV-2 Vaccine (Biological)
Patients who received two doses MODERNA vaccine, Arm 4
干预措施: MODERNA SARS-CoV-2 Vaccine (Biological)
结局指标
主要结局
Serum Level of Anti-RBD ( Anti Receptor Binding Domain )
时间窗: One month
To measure Anti-Spike, Anti-NP antibodies, and SARS-CoV-2 specific neutralization at 1 month (30 days) following third dose of vaccine (BNT162b2 versus mRNA-1273) binding antibody levels for anti-receptor-binding domain and antispike IgG were reported as relative ratios to a synthetic standard included as a calibration curve on each assay plate.
次要结局
- Serum Level of SARS-CoV-2 Antibodies(12 months)
- Proportion of B and T-cell Lymphocyte Subsets in Peripheral Blood Mononuclear Cells (PBMC)(1 month)
- Adverse Event(14 days)
- Adverse Events (30 Days)(1 month)
- Hospitalization(6 months)
- COVID-19 Infections(6 months)
- Death(6 months)