COVID-19 Vaccine Boosters in Patients With CKD

Phase 2

Terminated

• Conditions: Chronic Kidney Diseases; COVID-19
• Interventions: Biological: MODERNA SARS-CoV-2 Vaccine; Biological: Pfizer-BioNTech COVID-19 Vaccine

• Registration Number: NCT05022329
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-25
• Study First Posted: 2021-08-26
• Study Start: 2021-09-30
• Primary Completion: 2022-05-11
• Study Completion: 2022-11-15
• Status Verified: 2023-05
• Results First Submitted: 2023-12-15
• Results First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Results First Posted: 2025-02-19
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 273

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients who received two doses Pfizer-BioNTech vaccine ,Arm 3	MODERNA SARS-CoV-2 Vaccine	-
Patients who received two doses MODERNA vaccine, Arm 4	MODERNA SARS-CoV-2 Vaccine	-
Patients who received two doses Pfizer-BioNTech vaccine, Arm 1	Pfizer-BioNTech COVID-19 Vaccine	-
Patients who received two doses MODERNA vaccine, Arm 2	Pfizer-BioNTech COVID-19 Vaccine	-

Primary Outcome Measures

Name	Time	Method
Serum Level of Anti-RBD ( Anti Receptor Binding Domain )	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.

Secondary Outcome Measures

Name	Time	Method
Serum Level of SARS-CoV-2 Antibodies	12 months	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
Proportion of B and T-cell Lymphocyte Subsets in Peripheral Blood Mononuclear Cells (PBMC)	1 month	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.
Adverse Event	14 days	Evaluate adverse events related to third dose of vaccine through a questionnaire within 48 hours to 14 days following third vaccine dose.
Adverse Events (30 Days)	1 month	Evaluate adverse events related to third dose of vaccine through a questionnaire at 30 days following third vaccine dose.
Hospitalization	6 months	Number of participants who experienced COVID-19 related hospitalizations by study groups.
COVID-19 Infections	6 months	Number of participants who experienced COVID-19 infections and symptomatic COVID-19 infections.
Death	6 months	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).

Trial Locations

Locations (3)

Scarborough Health Network; 🇨🇦 Scarborough, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada

Sunnybrook Health Science Center; 🇨🇦 Toronto, Ontario, Canada