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Determining the Longitudinal Serologic Response to COVID-19 Vaccination in the Chronic Kidney Disease Population: A
Kevin Yau1,2, Omosomi Enilama3, Adeera Levin4,5
1Division of Nephrology, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
Insights
People with chronic kidney disease (CKD) show varied immune responses to COVID-19 vaccines. This study tracks antibody levels over time to inform vaccination strategies for this vulnerable group.
Area of Science:
- Immunology
- Nephrology
- Infectious Diseases
Background:
- Individuals with chronic kidney disease (CKD) faced higher risks during the COVID-19 pandemic.
- Limited data exists on the immune response and vaccine effectiveness in CKD patients.
Purpose of the Study:
- To characterize the longitudinal serologic response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination in patients with CKD.
- To inform vaccination strategies for this high-risk population.
Main Methods:
- Prospective observational cohort study involving up to 2500 participants with CKD G3b-5D, including dialysis and transplant recipients.
- Detection of SARS-CoV-2 IgG antibodies (anti-spike, anti-receptor binding domain, anti-nucleocapsid) via ELISA at 1, 3, 6, 9, and 12 months post-vaccination.
- Exploratory immune profiling of SARS-CoV-2 specific cellular immunity using peripheral blood mononuclear cells.
Main Results:
- Data on the kinetics of SARS-CoV-2 immune response to vaccination across the spectrum of CKD will be generated.
- Insights into the amplitude and duration of immunity conferred by COVID-19 vaccination will be provided.
- Factors associated with immune response in CKD patients will be characterized.
Conclusions:
- This large multicenter study will provide crucial data on COVID-19 vaccine immunogenicity in CKD patients.
- Results may inform immunization guidelines and public health recommendations for Canadians with CKD.
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.
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