COVID-19 Vaccine Boosters in Patients With CKD

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

Outcome

Met primary endpoint

Stopped: “Trial participants became eligible to receive their 4th dose of the COVID-19 vaccine vaccine thus data collected from the 12 month follow-up after 3rd dose vaccine, as per current protocol, would not not be relevant to the study outcomes.”

paper In patients with CKD, third dose COVID-19 mRNA vaccination with mRNA-1273 elicited higher SARS-CoV-2 anti-RBD levels in comparison with BNT162b2 over a 6-month period. PMID 37847518 ↗

Publications

• Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BNT162b2	Messenger RNA (mRNA)	30 ug	—
Subject	mRNA-1273	Messenger RNA (mRNA)	100 ug	—

Indications