Clinical trial NCT05022329: COVID-19 Vaccine Boosters in Patients With CKD
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Chronic Kidney Diseases
COVID-19
Keywords: Vaccine
CKD
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: Unity Health Toronto
name: Scarborough General Hospital
name: Providence Healthcare
First posted: 2021-08-26
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Serum Level of Anti-RBD ( Anti Receptor Binding Domain )
timeFrame: One month
Secondary outcomes:
measure: Serum Level of SARS-CoV-2 Antibodies
timeFrame: 3 months
measure: Serum Level of SARS-CoV-2 Antibodies
timeFrame: 6 months
measure: Serum Level of SARS-CoV-2 Antibodies
timeFrame: 12 months
measure: Proportion of B and T-cell Lymphocyte Subsets in Peripheral Blood Mononuclear Cells (PBMC)
timeFrame: 1 month
measure: Adverse Event
timeFrame: 14 days
measure: Adverse Events (30 Days)
timeFrame: 1 month
measure: Hospitalization
timeFrame: 6 months
measure: COVID-19 Infections
timeFrame: 6 months
measure: Death
timeFrame: 6 months
Other outcomes:
Locations:
city: Scarborough
country: Canada
facility: Scarborough Health Network
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Science Center
state: Ontario
Study officials:
References:
citation: Yau K, Tam P, Chan CT, Hu Q, Qi F, Abe KT, Kurtesi A, Jiang Y, Estrada-Codecido J, Brown T, Liu L, Siwakoti A, Leis JA, Levin A, Oliver MJ, Colwill K, Gingras AC, Hladunewich MA. BNT162b2 versus mRNA-1273 Third Dose COVID-19 Vaccine in Patients with CKD and Maintenance Dialysis Patients. Clin J Am Soc Nephrol. 2024 Jan 1;19(1):85-97. doi: 10.2215/CJN.0000000000000328. Epub 2023 Oct 17.