COVID-19 Vaccine Boosters in Patients With CKD

COVID-19 Clinical Trial

— BOOST KIDNEY  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05022329
• Other study ID #: 3750
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: September 30, 2021
• Est. completion date: November 15, 2022

Study information

• Verified date: May 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 268
• Est. completion date: November 15, 2022
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• COVID-19
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Biological:
• Pfizer-BioNTech COVID-19 Vaccine
This arm receives Pfizer-BioNTech COVID-19 Vaccine
• MODERNA SARS-CoV-2 Vaccine
This arm receives MODERNA SARS-CoV-2 Vaccine

Locations

Country	Name	City	State
Canada	Scarborough Health Network	Scarborough	Ontario
Canada	Sunnybrook Health Science Center	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Providence Healthcare, Scarborough General Hospital, Unity Health Toronto, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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