Chronic Kidney DiseasesPhase 2/3BOOST KIDNEYNCT05022329

COVID-19 Vaccine Boosters in Patients With CKD

A Phase 2/3 study testing Pfizer-BioNTech COVID-19 Vaccine and MODERNA SARS-CoV-2 Vaccine in people with Chronic Kidney Diseases and COVID-19, run by Sunnybrook Health Sciences Centre at 3 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Diseases, COVID-19
What is being tested?: Pfizer-BioNTech COVID-19 Vaccine and MODERNA SARS-CoV-2 Vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 273 participants
Where: 3 sitesCanada
Study dates: 30 Sep 2021to 15 Nov 2022
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

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

Other trials in Canada

About this study

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

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.

Read the detailed description

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

Conditions: Chronic Kidney Diseases, COVID-19
Being tested: Pfizer-BioNTech COVID-19 Vaccine, MODERNA SARS-CoV-2 Vaccine
Keywords: Vaccine, CKD
Medical subject headings: Renal Insufficiency, Chronic, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pfizer-BioNTech COVID-19 VaccineBiological
Also called BNT162b2 mRNA COVID-19 Vaccine
This arm receives Pfizer-BioNTech COVID-19 Vaccine
MODERNA SARS-CoV-2 VaccineBiological
Also called mRNA-1273 SARS-CoV-2 Vaccine
This arm receives MODERNA SARS-CoV-2 Vaccine

Study groups in NCT05022329
Study group	Role	What they receive
Patients who received two doses Pfizer-BioNTech vaccine, Arm 1	Experimental	Not described Receives: Biological: Pfizer-BioNTech COVID-19 Vaccine
Patients who received two doses MODERNA vaccine, Arm 2	Experimental	Not described Receives: Biological: Pfizer-BioNTech COVID-19 Vaccine
Patients who received two doses Pfizer-BioNTech vaccine ,Arm 3	Experimental	Not described Receives: Biological: MODERNA SARS-CoV-2 Vaccine
Patients who received two doses MODERNA vaccine, Arm 4	Experimental	Not described Receives: Biological: MODERNA SARS-CoV-2 Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Serum Level of Anti-RBD ( Anti Receptor Binding Domain )
To measure Anti-Spike, Anti-NP antibodies, and SARS-CoV-2 specific neutralization at 1 month (30 days) following third dose of vaccine (BNT162b2 versus mRNA-1273) binding antibody levels for anti-receptor-binding domain and antispike IgG were reported as relative ratios to a synthetic standard included as a calibration curve on each assay plate.
Measured: One month

Secondary outcomes (9)

Serum Level of SARS-CoV-2 Antibodies
To determine the effect of a third dose of COVID-19 vaccine on humoral immune response in hemodialysis patients through measurement of Anti-Spike, Anti-RBD, and Anti-NP antibodies at 3 months binding antibody levels for anti-receptor-binding domain and antispike IgG were reported as relative ratios to a synthetic standard included as a calibration curve on each assay plate.
Measured: 3 months
Serum Level of SARS-CoV-2 Antibodies
To determine the effect of a third dose of COVID-19 vaccine on humoral immune response in hemodialysis patients through measurement of Anti-Spike, Anti-RBD, and Anti-NP antibodies at 6 months binding antibody levels for anti-receptor-binding domain and antispike IgG were reported as relative ratios to a synthetic standard included as a calibration curve on each assay plate.
Measured: 6 months
Serum Level of SARS-CoV-2 Antibodies
Determine the effect of a third dose of COVID-19 vaccine on humoral immune response in hemodialysis patients through measurement of Anti-Spike, Anti-RBD, and Anti-NP antibodies at 12 months
Measured: 12 months
Proportion of B and T-cell Lymphocyte Subsets in Peripheral Blood Mononuclear Cells (PBMC)
In a subset of participants, assess cellular immunity through flow cytometry on PBMC and single-cell RNA sequencing prior to, one month, and 6 months following vaccine booster.
Measured: 1 month
Adverse Event
Evaluate adverse events related to third dose of vaccine through a questionnaire within 48 hours to 14 days following third vaccine dose.
Measured: 14 days
Adverse Events (30 Days)
Evaluate adverse events related to third dose of vaccine through a questionnaire at 30 days following third vaccine dose.
Measured: 1 month
Hospitalization
Number of participants who experienced COVID-19 related hospitalizations by study groups.
Measured: 6 months
COVID-19 Infections
Number of participants who experienced COVID-19 infections and symptomatic COVID-19 infections.
Measured: 6 months
Death
Differences in death between study groups. Death was collected for 6 months following third dose (shorted from 12 months due to the introduction of the 4th dose).
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 202115 Nov 2022

First posted26 Aug 2021
Study start30 Sep 2021
Primary completion11 May 2022
Study completion15 Nov 2022

Why it 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 273 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05022329
Sponsor's protocol ID: 3750
Acronym: BOOST KIDNEY
Status last verified: May 2023
First submitted: 23 Aug 2021
Last updated: 19 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Yau K, Tam P, Chan CT, Hu Q, Qi F, Abe KT, Kurtesi A, Jiang Y, Estrada-Codecido J, Brown T, Liu L, Siwakoti A, Leis JA, Levin A, Oliver MJ, Colwill K, Gingras AC, Hladunewich MA. BNT162b2 versus mRNA-1273 Third Dose COVID-19 Vaccine in Patients with CKD and Maintenance Dialysis Patients. Clin J Am Soc Nephrol. 2024 Jan 1;19(1):85-97. doi: 10.2215/CJN.0000000000000328. Epub 2023 Oct 17.
PubMed 37847518

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05022329
Acronym / sponsor ID: BOOST KIDNEY / 3750
Conditions: Chronic Kidney Diseases, COVID-19
Keywords: Vaccine, CKD
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason 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.
Enrolment: 273 participants (actual)
Lead sponsor: Sunnybrook Health Sciences CentreUniversity, hospital or other
Collaborators: University Health Network, Toronto, Unity Health Toronto, Scarborough General Hospital, Providence Healthcare
Study start: 30 Sep 2021 (actual)
Primary completion: 11 May 2022 (actual)
Study completion: 15 Nov 2022 (actual)
First posted: 26 Aug 2021 (actual)
Results: Posted 19 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Patients who received two doses Pfizer-BioNTech vaccine, Arm 1	Experimental	Biological: Pfizer-BioNTech COVID-19 Vaccine
Patients who received two doses MODERNA vaccine, Arm 2	Experimental	Biological: Pfizer-BioNTech COVID-19 Vaccine
Patients who received two doses Pfizer-BioNTech vaccine ,Arm 3	Experimental	Biological: MODERNA SARS-CoV-2 Vaccine
Patients who received two doses MODERNA vaccine, Arm 4	Experimental	Biological: MODERNA SARS-CoV-2 Vaccine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pfizer-BioNTech COVID-19 VaccineAlso: BNT162b2 mRNA COVID-19 VaccineThis arm receives Pfizer-BioNTech COVID-19 Vaccine	Biological	Patients who received two doses MODERNA vaccine, Arm 2, Patients who received two doses Pfizer-BioNTech vaccine, Arm 1
MODERNA SARS-CoV-2 VaccineAlso: mRNA-1273 SARS-CoV-2 VaccineThis arm receives MODERNA SARS-CoV-2 Vaccine	Biological	Patients who received two doses MODERNA vaccine, Arm 4, Patients who received two doses Pfizer-BioNTech vaccine ,Arm 3

Primary outcome

Serum Level of Anti-RBD ( Anti Receptor Binding Domain )
Time frame: One month
To measure Anti-Spike, Anti-NP antibodies, and SARS-CoV-2 specific neutralization at 1 month (30 days) following third dose of vaccine (BNT162b2 versus mRNA-1273) binding antibody levels for anti-receptor-binding domain and antispike IgG were reported as relative ratios to a synthetic standard included as a calibration curve on each assay plate.

9 secondary outcomes

Serum Level of SARS-CoV-2 Antibodies
Time frame: 3 months
Serum Level of SARS-CoV-2 Antibodies
Time frame: 6 months
Serum Level of SARS-CoV-2 Antibodies
Time frame: 12 months
Proportion of B and T-cell Lymphocyte Subsets in Peripheral Blood Mononuclear Cells (PBMC)
Time frame: 1 month
Adverse Event
Time frame: 14 days
Adverse Events (30 Days)
Time frame: 1 month
Hospitalization
Time frame: 6 months
COVID-19 Infections
Time frame: 6 months
Death
Time frame: 6 months

Results and safety

Results posted to the registry on 19 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Third Dose BNT162b2	137	119
Third Dose mRNA-1273	136	125

Primary outcome: Serum Level of Anti-RBD ( Anti Receptor Binding Domain )

Time frame: One month. Mean (Standard Deviation). Unit: relative ratio

Measure	Third Dose BNT162b2 n = 126	Third Dose mRNA-1273 n = 125
Anti-NP	0.0630 (0.334)	0.0415 (0.169)
Anti-RBD	0.807 (0.416)	0.934 (0.398)
Anti-spike	1.26 (0.358)	1.33 (0.289)

Population analysed: 7 participants withdrew from each arm and were not included in analysis. Only participants who provided samples for this timepoint were included in the analysis.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Third Dose BNT162b2	23 of 137 (16.8%)	82 of 129 (63.6%)	17 of 137
Third Dose mRNA-1273	16 of 136 (11.8%)	89 of 126 (70.6%)	9 of 136

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 37847518Yau K, Tam P, Chan CT, Hu Q, Qi F, Abe KT, Kurtesi A, Jiang Y, Estrada-Codecido J, Brown T, Liu L, Siwakoti A, Leis JA, Levin A, Oliver MJ, Colwill K, Gingras AC, Hladunewich MA. BNT162b2 versus mRNA-1273 Third Dose COVID-19 Vaccine in Patients with CKD and Maintenance Dialysis Patients. Clin J Am Soc Nephrol. 2024 Jan 1;19(1):85-97. doi: 10.2215/CJN.0000000000000328. Epub 2023 Oct 17.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Level of Anti-RBD ( Anti Receptor Binding Domain ) (time frame: One month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05022329, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.