NCT05022329

COVID-19 Vaccine Boosters in Patients With CKD

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Kidney Diseases
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Pfizer-BioNTech COVID-19 Vaccine	This arm receives Pfizer-BioNTech COVID-19 Vaccine
BIOLOGICAL	MODERNA SARS-CoV-2 Vaccine	This arm receives MODERNA SARS-CoV-2 Vaccine

Timeline

• Start date: 2021-09-30
• Primary completion: 2022-05-11
• Completion: 2022-11-15
• First posted: 2021-08-26
• Last updated: 2025-02-19
• Results posted: 2025-02-19

Locations

3 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study