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Determining the Longitudinal Serologic Response to COVID-19 Vaccination in the Chronic Kidney Disease Population: A Clinical Research Protocol
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 lim...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10028441/ https://www.ncbi.nlm.nih.gov/pubmed/36950028 http://dx.doi.org/10.1177/20543581231160511 |
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author | Yau, Kevin Enilama, Omosomi Levin, Adeera Romney, Marc G. Singer, Joel Blake, Peter Perl, Jeffrey Leis, Jerome A. Kozak, Robert Tsui, Hubert Bolotin, Shelly Tran, Vanessa Chan, Christopher T. Tam, Paul Dhruve, Miten Kandel, Christopher Estrada-Codecido, Jose Brown, Tyler Siwakoti, Aswani Abe, Kento T. Hu, Queenie Colwill, Karen Gingras, Anne-Claude Oliver, Matthew J. Hladunewich, Michelle A. |
author_facet | Yau, Kevin Enilama, Omosomi Levin, Adeera Romney, Marc G. Singer, Joel Blake, Peter Perl, Jeffrey Leis, Jerome A. Kozak, Robert Tsui, Hubert Bolotin, Shelly Tran, Vanessa Chan, Christopher T. Tam, Paul Dhruve, Miten Kandel, Christopher Estrada-Codecido, Jose Brown, Tyler Siwakoti, Aswani Abe, Kento T. Hu, Queenie Colwill, Karen Gingras, Anne-Claude Oliver, Matthew J. Hladunewich, Michelle A. |
author_sort | Yau, Kevin |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10028441 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-100284412023-03-21 Determining the Longitudinal Serologic Response to COVID-19 Vaccination in the Chronic Kidney Disease Population: A Clinical Research Protocol Yau, Kevin Enilama, Omosomi Levin, Adeera Romney, Marc G. Singer, Joel Blake, Peter Perl, Jeffrey Leis, Jerome A. Kozak, Robert Tsui, Hubert Bolotin, Shelly Tran, Vanessa Chan, Christopher T. Tam, Paul Dhruve, Miten Kandel, Christopher Estrada-Codecido, Jose Brown, Tyler Siwakoti, Aswani Abe, Kento T. Hu, Queenie Colwill, Karen Gingras, Anne-Claude Oliver, Matthew J. Hladunewich, Michelle A. Can J Kidney Health Dis COVID-19 Collection 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. SAGE Publications 2023-03-20 /pmc/articles/PMC10028441/ /pubmed/36950028 http://dx.doi.org/10.1177/20543581231160511 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
spellingShingle | COVID-19 Collection Yau, Kevin Enilama, Omosomi Levin, Adeera Romney, Marc G. Singer, Joel Blake, Peter Perl, Jeffrey Leis, Jerome A. Kozak, Robert Tsui, Hubert Bolotin, Shelly Tran, Vanessa Chan, Christopher T. Tam, Paul Dhruve, Miten Kandel, Christopher Estrada-Codecido, Jose Brown, Tyler Siwakoti, Aswani Abe, Kento T. Hu, Queenie Colwill, Karen Gingras, Anne-Claude Oliver, Matthew J. Hladunewich, Michelle A. Determining the Longitudinal Serologic Response to COVID-19 Vaccination in the Chronic Kidney Disease Population: A Clinical Research Protocol |
title | Determining the Longitudinal Serologic Response to COVID-19
Vaccination in the Chronic Kidney Disease Population: A Clinical Research
Protocol |
title_full | Determining the Longitudinal Serologic Response to COVID-19
Vaccination in the Chronic Kidney Disease Population: A Clinical Research
Protocol |
title_fullStr | Determining the Longitudinal Serologic Response to COVID-19
Vaccination in the Chronic Kidney Disease Population: A Clinical Research
Protocol |
title_full_unstemmed | Determining the Longitudinal Serologic Response to COVID-19
Vaccination in the Chronic Kidney Disease Population: A Clinical Research
Protocol |
title_short | Determining the Longitudinal Serologic Response to COVID-19
Vaccination in the Chronic Kidney Disease Population: A Clinical Research
Protocol |
title_sort | determining the longitudinal serologic response to covid-19
vaccination in the chronic kidney disease population: a clinical research
protocol |
topic | COVID-19 Collection |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10028441/ https://www.ncbi.nlm.nih.gov/pubmed/36950028 http://dx.doi.org/10.1177/20543581231160511 |
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