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Trial record 7 of 36 for:    3750

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05022329
Recruitment Status : Recruiting
First Posted : August 26, 2021
Last Update Posted : November 23, 2021
Sponsor:
Collaborators:
Sunnybrook Health Sciences Center
University Health Network, Toronto
Unity Health Toronto
Scarborough General Hospital
Providence Healthcare
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases COVID-19 Biological: Pfizer-BioNTech COVID-19 Vaccine Biological: MODERNA SARS-CoV-2 Vaccine Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : September 30, 2021
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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 Name: 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 Name: 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 Name: 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 Name: mRNA-1273 SARS-CoV-2 Vaccine




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. Adverse Event [ Time Frame: one month ]
    The safety of intervention will be evaluated with adverse event questionnaires.

  4. 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

  5. Number of patients with COVID-19 infections [ Time Frame: 12 months ]
    will be evaluated in medical records, differences between study groups

  6. Death [ Time Frame: 12 months ]
    will be evaluated in medical records, differences between the study groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05022329


Contacts
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Contact: Dr. Michelle Hladunewich, MD, FRCPC 416 480 4592 Michelle.Hladunewich@sunnybrook.ca
Contact: Gail Klein, MSc COVID-CKD@sunnybrook.ca

Locations
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Canada, Ontario
Scarborough Health Network Recruiting
Scarborough, Ontario, Canada, M1P 2V5
Contact: Dr. Paul Tam, MD       pywtam@gmail.com   
Principal Investigator: Dr. Paul Tam, MD         
University Health Network Not yet recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Dr. Christopher Chan, MD       Christopher.Chan@uhn.ca   
Principal Investigator: Dr. Christopher Chan, MD         
Sunnybrook Health Science Center Recruiting
Toronto, Ontario, Canada
Principal Investigator: Dr. Michelle Hladunewich         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Center
University Health Network, Toronto
Unity Health Toronto
Scarborough General Hospital
Providence Healthcare
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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT05022329    
Other Study ID Numbers: 3750
First Posted: August 26, 2021    Key Record Dates
Last Update Posted: November 23, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Sunnybrook Health Sciences Centre:
Vaccine
CKD
Additional relevant MeSH terms:
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COVID-19
Kidney Diseases
Renal Insufficiency, Chronic
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Urologic Diseases
Renal Insufficiency
Vaccines
Immunologic Factors
Physiological Effects of Drugs