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

May 2, 2023 updated by: Sunnybrook Health Sciences Centre

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

268

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Scarborough, Ontario, Canada, M1P 2V5
        • Scarborough Health Network
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network
      • Toronto, Ontario, Canada
        • Sunnybrook Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients who received two doses Pfizer-BioNTech vaccine, Arm 1
Biological: Pfizer-BioNTech COVID-19 Vaccine
This arm receives Pfizer-BioNTech COVID-19 Vaccine
Other Names:
  • BNT162b2 mRNA COVID-19 Vaccine
Experimental: Patients who received two doses MODERNA vaccine, Arm 2
Biological: Pfizer-BioNTech COVID-19 Vaccine
This arm receives Pfizer-BioNTech COVID-19 Vaccine
Other Names:
  • BNT162b2 mRNA COVID-19 Vaccine
Experimental: Patients who received two doses Pfizer-BioNTech vaccine ,Arm 3
Biological: MODERNA SARS-CoV-2 Vaccine
This arm receives MODERNA SARS-CoV-2 Vaccine
Other Names:
  • mRNA-1273 SARS-CoV-2 Vaccine
Experimental: Patients who received two doses MODERNA vaccine, Arm 4
Biological: MODERNA SARS-CoV-2 Vaccine
This arm receives MODERNA SARS-CoV-2 Vaccine
Other Names:
  • mRNA-1273 SARS-CoV-2 Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Level of Anti-RBD ( Anti Receptor Binding Domain )
Time Frame: One month
to evaluate the effect of third dose COVID-19 vaccine booster (BNT162b2 versus mRNA-1273) on serologic SARS-CoV-2 response
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Level of SARS-CoV-2 Antibodies (Spike, RBD-Receptor Binding Domain, NP- nucleocapsid protein)
Time Frame: 12 months
to evaluate the effect of third dose COVID-19 vaccine booster (BNT162b2 versus mRNA-1273)
12 months
Proportion of B and T-cell lymphocyte subsets in peripheral blood mononuclear cells (PBMC) in a subset of participants
Time Frame: 1 months
to evaluate SARS-CoV-2 specific B and T-Cell response
1 months
Adverse Event
Time Frame: one month
The safety of intervention will be evaluated with adverse event questionnaires.
one month
Hospitalization
Time Frame: 12 months
will be evaluated in follow up visits at 1,3,6 and 12 months after the intervention Differences between study groups
12 months
Number of patients with COVID-19 infections
Time Frame: 12 months
will be evaluated in medical records, differences between study groups
12 months
Death
Time Frame: 12 months
will be evaluated in medical records, differences between the study groups
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

University Health Network, Toronto
Unity Health Toronto
Scarborough General Hospital
Providence Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2021

Primary Completion (Actual)

May 11, 2022

Study Completion (Actual)

November 15, 2022

Study Registration Dates

First Submitted

August 23, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

August 26, 2021

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3750

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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