Yau K, Enilama O, Levin A, Romney MG, Singer J, Blake P, Perl J, Leis JA, Kozak R, Tsui H, Bolotin S, Tran V, Chan CT, Tam P, Dhruve M, Kandel C, Estrada-Codecido J, Brown T, Siwakoti A, Abe KT, Hu Q, Colwill K, Gingras AC, Oliver MJ, and Hladunewich MA
Background: People living with chronic kidney disease (CKD) have been disproportionately affected by the coronavirus disease 2019 (COVID-19) pandemic, including higher rates of infection, hospitalization, and death. Data on responsiveness to COVID-19 vaccination strategies and immunogenicity are limited, yet required to inform vaccination strategies in this at-risk population., Objective: The objective of this study is to characterize the longitudinal serologic response to COVID-19 vaccination., Design: This is a prospective observational cohort study., Setting: Participating outpatient kidney programs within Ontario and British Columbia., Patients: Up to 2500 participants with CKD G3b-5D receiving COVID-19 vaccination, including participants receiving dialysis and kidney transplant recipients (CKD G1T-5T)., Measurements: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG antibodies (anti-spike, anti-receptor binding domain, anti-nucleocapsid) will be detected by ELISA (enzyme-linked immunosorbent assay) from serum or dried blood spot testing. In a subset of participants, neutralizing antibodies against novel variants of concern will be evaluated. Peripheral blood mononuclear cells will be collected for exploratory immune profiling of SARS-CoV-2 specific cellular immunity., Methods: Participants will be recruited prior to or following any COVID-19 vaccine dose and have blood sampled for serological testing at multiple timepoints: 1, 3, 6, 9, and 12 months post vaccination. When possible, samples will be collected prior to a dose or booster. Participants will remain in the study for at least 1 year following their last COVID-19 vaccine dose., Strengths and Limitations: The adaptive design of this study allows for planned modification based on emerging evidence or rapid changes in public health policy surrounding vaccination. Limitations include incomplete earlier timepoints for blood collection due to rapid vaccination of the population., Conclusions: This large multicenter serologic study of participants living with kidney disease will generate data on the kinetics of SARS-CoV-2 immune response to vaccination across the spectrum of CKD, providing insights into the amplitude and duration of immunity conferred by COVID-19 vaccination and allowing for characterization of factors associated with immune response. The results of this study may be used to inform immunization guidelines and public health recommendations for the 4 million Canadians living with CKD., Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Kevin Yau has received speaker fees from AstraZeneca. Adeera Levin reports being a scientific advisor to, or member of, AstraZeneca, Bayer, Boehringer-Ingelheim, Canadian Journal of Kidney Health and Disease, Canadian Institutes of Health Research, Certa, Chinook Therapeutics, Johnson and Johnson, Kidney Foundation of Canada, National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Otsuka, Reata, Retrophin, and The George Institute; receiving research funding from AstraZeneca, Boehringer-Ingelheim, Canadian Institute of Health Research, Janssen, Johnson and Johnson, Kidney Foundation of Canada, Merck, NIDDK, NIH, Ortho Biotech, Otsuka, and Oxford Clinical Trials; and having consultancy agreements with Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, Johnson and Johnson/Jansen, Reata, and Retrophin. Marc Romney has received research support from Public Health Agency of Canada and the COVID-19 Immunity Task Force. Jeffrey Perl reports receiving speaking honoraria and consultancy fees from Baxter Healthcare; grants from Agency for Healthcare Research and Quality grant support; speaking honoraria from Fresenius Medical Care, AstraZeneca, Davita Healthcare, and US Renal Care; and consultancy fees from LiberDi Dialysis outside the submitted work. Shelly Bolotin reports funding from the Canadian Institutes of Health Research, the Canadian Immunization Research Network, the COVID-19 Immunity Task Force, and the Public Health Agency of Canada, outside the submitted work. She is a member of the Canadian Immunization Research Network Management Committee, COVID-19 Immunity Task Force Leadership Group. Vanessa Tran reports that Public Health Ontario received funding from the Public Health Agency of Canada and test kits from the Canadian Immunity Task Force for COVID-19 serosurveillance studies. Public Health Ontario is also involved in a COVID-19 mix-and-match vaccine clinical trial. Shelly Bolotin and Vanessa Tran are employees of Public Health Ontario. Anne-Claude Gingras has received research funds from a research contract with Providence Therapeutics Holdings, Inc, for other projects, participates in the COVID-19 Immunity Task Force (CITF) Immune Science and Testing working party, chairs the CIHR Institute of Genetics Advisory Board, and is a member of the SAB of the National Research Council of Canada Human Health Therapeutics Board. Matthew Oliver and Michelle Hladunewich are contracted Medical Leads at Ontario Renal Network, Ontario Health. Matthew Oliver is owner of Oliver Medical Management Inc., which licenses Dialysis Management Analysis and Reporting System software. He has received honoraria for speaking from Baxter Healthcare. Michelle Hladunewich reports receiving grants from Pfizer for a study in focal segmental glomerulosclerosis; Ionis, Calliditas, and Chinook for studies in Immunoglobulin A nephropathy; and Roche for a preeclampsia study. No other competing interests were declared., (© The Author(s) 2023.)