BNT162b2 versus mRNA-1273 Third Dose COVID-19 Vaccine in Patients with CKD and Maintenance Dialysis Patients.

Autor:	Yau K; Division of Nephrology, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.; Division of Nephrology, Department of Medicine, University Health Network, Toronto, Ontario, Canada.; Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada., Tam P; Division of Nephrology, Department of Medicine, Scarborough Health Network, Toronto, Ontario, Canada., Chan CT; Division of Nephrology, Department of Medicine, University Health Network, Toronto, Ontario, Canada.; Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada., Hu Q; Lunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital, Sinai Health System, Toronto, Ontario, Canada., Qi F; Lunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital, Sinai Health System, Toronto, Ontario, Canada., Abe KT; Lunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital, Sinai Health System, Toronto, Ontario, Canada.; Department of Molecular Genetics, University of Toronto, Toronto, Ontario, Canada., Kurtesi A; Lunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital, Sinai Health System, Toronto, Ontario, Canada., Jiang Y; Clinical Trial Support, Sunnybrook Research Institute, Toronto, Ontario, Canada., Estrada-Codecido J; Division of Nephrology, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada., Brown T; Division of Nephrology, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada., Liu L; Division of Nephrology, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada., Siwakoti A; Division of Nephrology, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada., Leis JA; Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.; Division of Infectious Diseases, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada., Levin A; British Columbia Provincial Renal Agency, Vancouver, British Columbia, Canada., Oliver MJ; Division of Nephrology, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.; Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.; Ontario Renal Network, Ontario Health, Toronto, Ontario, Canada., Colwill K; Lunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital, Sinai Health System, Toronto, Ontario, Canada., Gingras AC; Lunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital, Sinai Health System, Toronto, Ontario, Canada.; Department of Molecular Genetics, University of Toronto, Toronto, Ontario, Canada., Hladunewich MA; Division of Nephrology, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.; Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.; Ontario Renal Network, Ontario Health, Toronto, Ontario, Canada.
Jazyk:	angličtina
Zdroj:	Clinical journal of the American Society of Nephrology : CJASN [Clin J Am Soc Nephrol] 2024 Jan 01; Vol. 19 (1), pp. 85-97. Date of Electronic Publication: 2023 Oct 17.
DOI:	10.2215/CJN.0000000000000328
Abstrakt:	Background: There is a lack of randomized controlled trial data regarding differences in immunogenicity of varying coronavirus disease 2019 (COVID-19) mRNA vaccine regimens in CKD populations. Methods: We conducted a randomized controlled trial at three kidney centers in Toronto, Ontario, Canada, evaluating the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody response after third dose vaccination. Participants ( n =273) with CKD not on dialysis or receiving dialysis were randomized 1:1 to third dose 30- µ g BNT162b2 (Pfizer-BioNTech) or 100- µ g mRNA-1273 (Moderna). The primary outcome of this study was SARS-CoV-2 IgG-binding antibodies to the receptor-binding domain (anti-RBD). Spike protein (antispike), nucleocapsid protein, and vaccine reactogenicity were also evaluated. Serology was measured before third dose and 1, 3, and 6 months after third dose. A subset of participants ( n =100) were randomly selected to assess viral pseudovirus neutralization against wild-type D614G, B.1.617.2 (Delta), and B.1.1.529 (Omicron BA.1). Results: Among 273 participants randomized, 94% were receiving maintenance dialysis and 59% received BNT162b2 for initial two dose COVID-19 vaccination. Third dose of mRNA-1273 was associated with higher mean anti-RBD levels (1871 binding antibody units [BAU]/ml; 95% confidence interval [CI], 829 to 2988) over a 6-month period in comparison with third dose BNT162b2 (1332 BAU/ml; 95% CI, 367 to 2402) with a difference of 539 BAU/ml (95% CI, 139 to 910; P = 0.009). Neither antispike levels nor neutralizing antibodies to wild-type, Delta, and Omicron BA.1 pseudoviruses were statistically different. COVID-19 infection occurred in 10% of participants: 15 (11%) receiving mRNA-1273 and 11 (8%) receiving BNT162b2. Third dose BNT162b2 was not associated with a significant different risk for COVID-19 in comparison with mRNA-1273 (hazard ratio, 0.78; 95% CI, 0.27 to 2.2; P = 0.63). Conclusions: 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. Clinical Trial Registry Name and Registration Number: COVID-19 Vaccine Boosters in Patients With CKD (BOOST KIDNEY), NCT05022329 . (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Nephrology.)
Databáze:	MEDLINE
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