COVID-19 Vaccine Boosters in Patients With CKD (BOOST KIDNEY)

Sunnybrook Health Sciences Centre

Status and phase

Terminated

Phase 3

Phase 2

Conditions

COVID-19

Chronic Kidney Diseases

Treatments

Biological: Pfizer-BioNTech COVID-19 Vaccine

Biological: MODERNA SARS-CoV-2 Vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT05022329

3750

Details and patient eligibility

About

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.

Full description

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

Enrollment

273 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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