COVID-19 Vaccine Boosters in Patients With CKD

Study Overview
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Brief Summary
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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
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MODERNA : Nucleocapsid Modified messenger RNA BioNTech: Bio-Pharma new Technology

Official Title
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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

Conditions
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COVID-19, Chronic Kidney Diseases

Intervention / Treatment
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* Biological: Pfizer-BioNTech COVID-19 Vaccine
* Biological: MODERNA SARS-CoV-2 Vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients who received two doses Pfizer-BioNTech vaccine, Arm 1<br> | Biological: Pfizer-BioNTech COVID-19 Vaccine<br>* This arm receives Pfizer-BioNTech COVID-19 Vaccine<br>* Other names: BNT162b2 mRNA COVID-19 Vaccine;|
| Experimental: Patients who received two doses MODERNA vaccine, Arm 2<br> | Biological: Pfizer-BioNTech COVID-19 Vaccine<br>* This arm receives Pfizer-BioNTech COVID-19 Vaccine<br>* Other names: BNT162b2 mRNA COVID-19 Vaccine;|
| Experimental: Patients who received two doses Pfizer-BioNTech vaccine ,Arm 3<br> | Biological: MODERNA SARS-CoV-2 Vaccine<br>* This arm receives MODERNA SARS-CoV-2 Vaccine<br>* Other names: mRNA-1273 SARS-CoV-2 Vaccine;|
| Experimental: Patients who received two doses MODERNA vaccine, Arm 4<br> | Biological: MODERNA SARS-CoV-2 Vaccine<br>* This arm receives MODERNA SARS-CoV-2 Vaccine<br>* Other names: mRNA-1273 SARS-CoV-2 Vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 12 months | 
| 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 | 1 months | 
| Adverse Event | The safety of intervention will be evaluated with adverse event questionnaires. | one month | 
| Hospitalization | will be evaluated in follow up visits at 1,3,6 and 12 months after the intervention Differences between study groups | 12 months | 
| Number of patients with COVID-19 infections | will be evaluated in medical records, differences between study groups | 12 months | 
| Death | will be evaluated in medical records, differences between the study groups | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccine, CKD