Official Title
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
Brief Summary

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.

Detailed Description

MODERNA : Nucleocapsid Modified messenger RNA BioNTech: Bio-Pharma new Technology

Terminated
Chronic Kidney Diseases
COVID-19

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

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Canada
Locations

Scarborough Health Network
Scarborough, Ontario, Canada

University Health Network
Toronto, Ontario, Canada

Sunnybrook Health Science Center
Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre
NCT Number
Keywords
Vaccine
CKD
MeSH Terms
COVID-19
Kidney Diseases
Renal Insufficiency, Chronic
Vaccines