drugset / Trial / NCT05022329

COVID-19 Vaccine Boosters in Patients With CKD

NCT05022329

RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2021-09-30
Primary completion
2022-05-11
Completion
2022-11-15

Drugs

EvaluationDrugModalityDoseRoute
Subject BNT162b2 Messenger RNA (mRNA) 30 ug
Subject Elasomeran Messenger RNA (mRNA) 100 ug