TY - JOUR
T1 - Immunogenicity of SARS-CoV-2 vaccine in dialysis
AU - Lacson, Eduardo
AU - Argyropoulos, Christos P.
AU - Manley, Harold J.
AU - Aweh, Gideon
AU - Chin, Andrew I.
AU - Salman, Loay H.
AU - Hsu, Caroline M.
AU - Johnson, Doug S.
AU - Weiner, Daniel E.
N1 - Funding Information:
A.I. Chin reports being a scientific advisor to or membership of the National Quality Forum, renal committee; and reports other interests/relationships as Medical Director of a dialysis clinic owned by DCI. A.I. Chin, C.P. Argyropoulos, D.E. Weiner, and L.H. Salman are medical directors of DCI facilities. C.P. Argyropoulos reports having consultancy agreements with Alkahest and Momenta Pharma; reports receiving research funding from DCI and the University of Pennsylvania; reports being a scientific advisor or member of Baxter Healthcare, Bayer, and the Health Services Advisory Group; and reports having other interests/relationships in Akebia (Principal Investigator [PI]) in two phase 3 trials of an investigational product for the correction and maintenance of anemia in patients with nondialysis-dependent CKD and one phase 3 study of the same agent in dialysis, AbbVie Sub-I in a phase 3 study of an experimental agent in diabetic nephropathy, DCI as Medical Director, Outpatient Dialysis Unit in Cuba and New Mexico, and Dialysis Outcomes and Practice Patterns Study PI for CKD-Dialysis Outcomes and Practice Patterns Study. D.E. Weiner reports receiving funding paid to his institution for his role as Medical Director of Clinical Research for DCI; reports consultancy agreements via the Medical Advisory Boards for Akebia (2020, 2021), Cara Therapeutics (2020), Janssen Biopharmaceuticals (2019), and Tricida (2019); reports receiving honoraria for Akebia, paid to DCI; reports receiving research funding paid to AstraZeneca (site PI, DAPA-CKD Trial, capitated on the basis of recruitment, completed 2020), DCI (including local site PI for multiple clinical trials contracted through DCI, including trials sponsored by Arde-lyx, ongoing, and Cara Therapeutics, completed), Goldfinch Bio (site PI, capitated on the basis of recruitment, ongoing), and Janssen Biopharma-ceuticals (site PI, CREDENCE Trial, capitated on the basis of recruitment, completed 2019); reports receiving honoraria from the National Kidney Foundation (NKF) for an editorial position at Kidney Medicine and American Journal of Kidney Diseases, Elsevier for royalties from the NKF’s Primer on Kidney Diseases; and reports being a scientific advisor or member as Co-Editor-in-Chief of NKF Primer on Kidney Diseases 8th Edition, Editor-in-Chief of Kidney Medicine, Medical Director of Clinical Research at DCI, member of the ASN Quality and Policy Committees and ASN representative to Kidney Care Partners, Scientific Advisory Board of the NKF; and reports other interests/relationships as Chair of the adjudications committee for Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis Trial (George Institute, CRO, sponsored by Tricida), Member of Data Monitoring Committee, “Feasibility of Hemodialysis with GARNET? in Chronic Hemodialysis Patients with a Bloodstream Infection” trial (Avania CRO). D.S. Johnson reports being a scientific advisor to or member of Alive Hospice and American Association of Kidney Patients. D.S. Johnson, E. Lacson, H.J. Manley, and G. Aweh are employees of DCI. L.H. Salman reports receiving research funding from Albany Medical Center, Roach funds, Transonics Inc.; reports patents and inventions for the use of 4-methylumbelliferone in diabetic kidney disease; and reports having other interests/relationships with American Society of Diagnostic and Interventional Nephrology, the American Society of Nephrology, the Data Safety Monitoring Board of Phraxis, and the Renal Physician Association. The remaining author has nothing to disclose.
Funding Information:
This work was supported by the National Institute of Diabetes and Digestive and Kidney Diseases grant T32-DK007777 (to C. Hsu).
Publisher Copyright:
Copyright ß 2021 by the American Society of Nephrology
PY - 2021/11
Y1 - 2021/11
N2 - Background Patients receiving maintenance dialysis represent a high-risk, immune-compromised population with 15%–25% COVID-19 mortality rate who were unrepresented in clinical trials of mRNA vaccines. Methods All patients receiving maintenance dialysis who received two doses of SARS-CoV-2 mRNA vaccines with antibody test results drawn $14 days after the second dose, as documented in the electronic health record through March 18, 2021, were included. Response was on the basis of levels of Ig-G against the receptor binding domain of the S1 subunit of SARS-CoV-2 spike-antigen (seropositive $2 U/L) using an FDA-approved semiquantitative chemiluminescent assay (ADVIA Centaur XP/XPT COV2G). Results Among 186 patients on dialysis from 30 clinics in eight states tested 2368 days after receiving two vaccine doses, there were 165 (88.7%) responders with 70% at maximum titer. There was no significant difference between BNT162b2/ Pfizer (148 out of 168, 88.1%) and mRNA-1273/Moderna (17 out of 18, 94.4%), P50.42. All 38 patients with COVID-19 history were responders, with 97% at maximum titer. Among patients without COVID-19, 127 out of 148 (85.8%) were responders, comparable between BNT162b2/Pfizer (113 out of 133) and mRNA-1273/ Moderna (14 out of 15) vaccines (85.0% versus 93.3%, P50.38). Conclusions Most patients receiving maintenance dialysis responded after two doses of BNT162b2/Pfizer or mRNA-1273/Moderna vaccine, suggesting the short-term development of antispike antibody is good, giving hope that most of these patients who are vulnerable, once immunized, will be protected from COVID-19. Longer-term evaluation is needed to determine antibody titer durability and if booster dose(s) are warranted. Further research to evaluate the approach to patients without a serologic response is needed, including benefits of additional dose(s) or administration of alternate options.
AB - Background Patients receiving maintenance dialysis represent a high-risk, immune-compromised population with 15%–25% COVID-19 mortality rate who were unrepresented in clinical trials of mRNA vaccines. Methods All patients receiving maintenance dialysis who received two doses of SARS-CoV-2 mRNA vaccines with antibody test results drawn $14 days after the second dose, as documented in the electronic health record through March 18, 2021, were included. Response was on the basis of levels of Ig-G against the receptor binding domain of the S1 subunit of SARS-CoV-2 spike-antigen (seropositive $2 U/L) using an FDA-approved semiquantitative chemiluminescent assay (ADVIA Centaur XP/XPT COV2G). Results Among 186 patients on dialysis from 30 clinics in eight states tested 2368 days after receiving two vaccine doses, there were 165 (88.7%) responders with 70% at maximum titer. There was no significant difference between BNT162b2/ Pfizer (148 out of 168, 88.1%) and mRNA-1273/Moderna (17 out of 18, 94.4%), P50.42. All 38 patients with COVID-19 history were responders, with 97% at maximum titer. Among patients without COVID-19, 127 out of 148 (85.8%) were responders, comparable between BNT162b2/Pfizer (113 out of 133) and mRNA-1273/ Moderna (14 out of 15) vaccines (85.0% versus 93.3%, P50.38). Conclusions Most patients receiving maintenance dialysis responded after two doses of BNT162b2/Pfizer or mRNA-1273/Moderna vaccine, suggesting the short-term development of antispike antibody is good, giving hope that most of these patients who are vulnerable, once immunized, will be protected from COVID-19. Longer-term evaluation is needed to determine antibody titer durability and if booster dose(s) are warranted. Further research to evaluate the approach to patients without a serologic response is needed, including benefits of additional dose(s) or administration of alternate options.
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U2 - 10.1681/ASN.2021040432
DO - 10.1681/ASN.2021040432
M3 - Article
C2 - 34348908
AN - SCOPUS:85115656424
VL - 32
SP - 2735
EP - 2742
JO - Journal of the American Society of Nephrology : JASN
JF - Journal of the American Society of Nephrology : JASN
SN - 1046-6673
IS - 11
ER -