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COVID-19 Vaccine Boosters in Patients With CKD

NCT05022329 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2025-02-19

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University Health Network, Toronto

    collaborator OTHER

  • Unity Health Toronto

    collaborator OTHER

  • Scarborough General Hospital

    collaborator OTHER

  • Providence Healthcare

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2022-05-11
Completion
2022-11-15
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05022329 on ClinicalTrials.gov