Kevin Yau, Omosomi Enilama, Adeera Levin, Marc G Romney, Joel Singer, Peter Blake, Jeffrey Perl, Jerome A Leis, Robert Kozak, Hubert Tsui, Shelly Bolotin, Vanessa Tran, Christopher T Chan, Paul Tam, Miten Dhruve, Christopher Kandel, Jose Estrada-Codecido, Tyler Brown, Aswani Siwakoti, Kento T Abe, Queenie Hu, Karen Colwill, Anne-Claude Gingras, Matthew J Oliver, Michelle A Hladunewich
{"title":"确定慢性肾脏疾病人群对COVID-19疫苗接种的纵向血清学反应:一项临床研究方案","authors":"Kevin Yau, Omosomi Enilama, Adeera Levin, Marc G Romney, Joel Singer, Peter Blake, Jeffrey Perl, Jerome A Leis, Robert Kozak, Hubert Tsui, Shelly Bolotin, Vanessa Tran, Christopher T Chan, Paul Tam, Miten Dhruve, Christopher Kandel, Jose Estrada-Codecido, Tyler Brown, Aswani Siwakoti, Kento T Abe, Queenie Hu, Karen Colwill, Anne-Claude Gingras, Matthew J Oliver, Michelle A Hladunewich","doi":"10.1177/20543581231160511","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>The objective of this study is to characterize the longitudinal serologic response to COVID-19 vaccination.</p><p><strong>Design: </strong>This is a prospective observational cohort study.</p><p><strong>Setting: </strong>Participating outpatient kidney programs within Ontario and British Columbia.</p><p><strong>Patients: </strong>Up to 2500 participants with CKD G3b-5D receiving COVID-19 vaccination, including participants receiving dialysis and kidney transplant recipients (CKD G1T-5T).</p><p><strong>Measurements: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Strengths and limitations: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":9426,"journal":{"name":"Canadian Journal of Kidney Health and Disease","volume":null,"pages":null},"PeriodicalIF":1.6000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/56/ea/10.1177_20543581231160511.PMC10028441.pdf","citationCount":"1","resultStr":"{\"title\":\"Determining the Longitudinal Serologic Response to COVID-19 Vaccination in the Chronic Kidney Disease Population: A Clinical Research Protocol.\",\"authors\":\"Kevin Yau, Omosomi Enilama, Adeera Levin, Marc G Romney, Joel Singer, Peter Blake, Jeffrey Perl, Jerome A Leis, Robert Kozak, Hubert Tsui, Shelly Bolotin, Vanessa Tran, Christopher T Chan, Paul Tam, Miten Dhruve, Christopher Kandel, Jose Estrada-Codecido, Tyler Brown, Aswani Siwakoti, Kento T Abe, Queenie Hu, Karen Colwill, Anne-Claude Gingras, Matthew J Oliver, Michelle A Hladunewich\",\"doi\":\"10.1177/20543581231160511\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>The objective of this study is to characterize the longitudinal serologic response to COVID-19 vaccination.</p><p><strong>Design: </strong>This is a prospective observational cohort study.</p><p><strong>Setting: </strong>Participating outpatient kidney programs within Ontario and British Columbia.</p><p><strong>Patients: </strong>Up to 2500 participants with CKD G3b-5D receiving COVID-19 vaccination, including participants receiving dialysis and kidney transplant recipients (CKD G1T-5T).</p><p><strong>Measurements: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Strengths and limitations: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":9426,\"journal\":{\"name\":\"Canadian Journal of Kidney Health and Disease\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.6000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/56/ea/10.1177_20543581231160511.PMC10028441.pdf\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Canadian Journal of Kidney Health and Disease\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/20543581231160511\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Canadian Journal of Kidney Health and Disease","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/20543581231160511","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
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 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.
期刊介绍：
Canadian Journal of Kidney Health and Disease, the official journal of the Canadian Society of Nephrology, is an open access, peer-reviewed online journal that encourages high quality submissions focused on clinical, translational and health services delivery research in the field of chronic kidney disease, dialysis, kidney transplantation and organ donation. Our mandate is to promote and advocate for kidney health as it impacts national and international communities. Basic science, translational studies and clinical studies will be peer reviewed and processed by an Editorial Board comprised of geographically diverse Canadian and international nephrologists, internists and allied health professionals; this Editorial Board is mandated to ensure highest quality publications.
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