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.
MODERNA : Nucleocapsid Modified messenger RNA BioNTech: Bio-Pharma new Technology
Biological: Pfizer-BioNTech COVID-19 Vaccine
This arm receives Pfizer-BioNTech COVID-19 Vaccine
Other Name: BNT162b2 mRNA COVID-19 Vaccine
Biological: MODERNA SARS-CoV-2 Vaccine
This arm receives MODERNA SARS-CoV-2 Vaccine
Other Name: mRNA-1273 SARS-CoV-2 Vaccine
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Scarborough Health Network
Scarborough, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Sunnybrook Health Science Center
Toronto, Ontario, Canada