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

Primary Purpose

Chronic Kidney Diseases, COVID-19

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Pfizer-BioNTech COVID-19 Vaccine
MODERNA SARS-CoV-2 Vaccine
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Diseases focused on measuring Vaccine, CKD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Scarborough Health Network
  • University Health Network
  • Sunnybrook Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Patients who received two doses Pfizer-BioNTech vaccine, Arm 1

Patients who received two doses MODERNA vaccine, Arm 2

Patients who received two doses Pfizer-BioNTech vaccine ,Arm 3

Patients who received two doses MODERNA vaccine, Arm 4

Arm Description

Outcomes

Primary Outcome Measures

Serum Level of Anti-RBD ( Anti Receptor Binding Domain )
to evaluate the effect of third dose COVID-19 vaccine booster (BNT162b2 versus mRNA-1273) on serologic SARS-CoV-2 response

Secondary Outcome Measures

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

Full Information

First Posted
August 23, 2021
Last Updated
May 2, 2023
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
University Health Network, Toronto, Unity Health Toronto, Scarborough General Hospital, Providence Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT05022329
Brief Title
COVID-19 Vaccine Boosters in Patients With CKD
Acronym
BOOST KIDNEY
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Trial participants became eligible to receive their 4th dose of the COVID-19 vaccine vaccine thus data collected from the 12 month follow-up after 3rd dose vaccine, as per current protocol, would not not be relevant to the study outcomes.
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
May 11, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
University Health Network, Toronto, Unity Health Toronto, Scarborough General Hospital, Providence Healthcare

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, COVID-19
Keywords
Vaccine, CKD

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients who received two doses Pfizer-BioNTech vaccine, Arm 1
Arm Type
Experimental
Arm Title
Patients who received two doses MODERNA vaccine, Arm 2
Arm Type
Experimental
Arm Title
Patients who received two doses Pfizer-BioNTech vaccine ,Arm 3
Arm Type
Experimental
Arm Title
Patients who received two doses MODERNA vaccine, Arm 4
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Pfizer-BioNTech COVID-19 Vaccine
Other Intervention Name(s)
BNT162b2 mRNA COVID-19 Vaccine
Intervention Description
This arm receives Pfizer-BioNTech COVID-19 Vaccine
Intervention Type
Biological
Intervention Name(s)
MODERNA SARS-CoV-2 Vaccine
Other Intervention Name(s)
mRNA-1273 SARS-CoV-2 Vaccine
Intervention Description
This arm receives MODERNA SARS-CoV-2 Vaccine
Primary Outcome Measure Information:
Title
Serum Level of Anti-RBD ( Anti Receptor Binding Domain )
Description
to evaluate the effect of third dose COVID-19 vaccine booster (BNT162b2 versus mRNA-1273) on serologic SARS-CoV-2 response
Time Frame
One month
Secondary Outcome Measure Information:
Title
Serum Level of SARS-CoV-2 Antibodies (Spike, RBD-Receptor Binding Domain, NP- nucleocapsid protein)
Description
to evaluate the effect of third dose COVID-19 vaccine booster (BNT162b2 versus mRNA-1273)
Time Frame
12 months
Title
Proportion of B and T-cell lymphocyte subsets in peripheral blood mononuclear cells (PBMC) in a subset of participants
Description
to evaluate SARS-CoV-2 specific B and T-Cell response
Time Frame
1 months
Title
Adverse Event
Description
The safety of intervention will be evaluated with adverse event questionnaires.
Time Frame
one month
Title
Hospitalization
Description
will be evaluated in follow up visits at 1,3,6 and 12 months after the intervention Differences between study groups
Time Frame
12 months
Title
Number of patients with COVID-19 infections
Description
will be evaluated in medical records, differences between study groups
Time Frame
12 months
Title
Death
Description
will be evaluated in medical records, differences between the study groups
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Scarborough Health Network
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1P 2V5
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Sunnybrook Health Science Center
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

COVID-19 Vaccine Boosters in Patients With CKD

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