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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05022329
Other study ID # 3750
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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