COVID-19 Vaccine Boosters in Patients With CKD

Phase 3TerminatedNCT05022329

Sunnybrook Health Sciences Centre273 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

273

Conditions

Chronic Kidney Diseases COVID-19

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Scarborough Health Network

Scarborough Village, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Sunnybrook Health Science Center

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: One month

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 1 month

Hospitalization

Number of participants who experienced COVID-19 related hospitalizations by study groups.

Time frame: 6 months

COVID-19 Infections

Number of participants who experienced COVID-19 infections and symptomatic COVID-19 infections.

Time frame: 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).

Time frame: 6 months