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Immunogenicity and safety of inactivated SARS-CoV-2 vaccine in haemodialysis patients: a prospective cohort study

End-stage renal disease patients on haemodialysis (HD) have been largely excluded from SARS-CoV-2 vaccine trials due to safety reasons and shown to mount lower responses to vaccination. This study aims to evaluate the immunogenicity and safety of inactivated COVID-19 vaccine among HD patients compar...

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Autores principales: Puspitasari, Metalia, Sattwika, Prenali D., Rahari, Dzerlina S., Wijaya, Wynne, Hidayat, Auliana R. P., Kertia, Nyoman, Purwanto, Bambang, Thobari, Jarir At
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10354113/
https://www.ncbi.nlm.nih.gov/pubmed/37463975
http://dx.doi.org/10.1038/s41598-023-38628-2
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author Puspitasari, Metalia
Sattwika, Prenali D.
Rahari, Dzerlina S.
Wijaya, Wynne
Hidayat, Auliana R. P.
Kertia, Nyoman
Purwanto, Bambang
Thobari, Jarir At
author_facet Puspitasari, Metalia
Sattwika, Prenali D.
Rahari, Dzerlina S.
Wijaya, Wynne
Hidayat, Auliana R. P.
Kertia, Nyoman
Purwanto, Bambang
Thobari, Jarir At
author_sort Puspitasari, Metalia
collection PubMed
description End-stage renal disease patients on haemodialysis (HD) have been largely excluded from SARS-CoV-2 vaccine trials due to safety reasons and shown to mount lower responses to vaccination. This study aims to evaluate the immunogenicity and safety of inactivated COVID-19 vaccine among HD patients compared to healthy controls. All subjects who received the primary inactivated COVID-19 vaccination had their blood samples tested 21 days after the second dose. We report the immunogenicity based on anti-RBD IgG titre (IU/mL), the inhibition rate of neutralizing antibodies (NAbs) (%) to RBD, and seroconversion rates. Adverse events were assessed within 30 min and on the 7th day after each dose. Among 75 HD patients and 71 healthy controls, we observed no significant difference in all immunogenicity measures: anti-RBD IgG GMT (277.91 ± 7.13 IU/mL vs. 315.50 ± 3.50 IU/mL, p = 0.645), NAbs inhibition rate (82% [53–96] vs. 84% [39–98], p = 0.654), and seroconversion rates (anti-RBD IgG: 86.7% vs. 85.9%, p = 0.895; NAbs: 45.3% vs. 60.6%, p = 0.065). The number of adverse events is not significantly different between the two groups. The primary inactivated SARS-CoV-2 vaccination elicits an adequate antibody response and can be safely administered in haemodialysis patients.
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spelling pubmed-103541132023-07-20 Immunogenicity and safety of inactivated SARS-CoV-2 vaccine in haemodialysis patients: a prospective cohort study Puspitasari, Metalia Sattwika, Prenali D. Rahari, Dzerlina S. Wijaya, Wynne Hidayat, Auliana R. P. Kertia, Nyoman Purwanto, Bambang Thobari, Jarir At Sci Rep Article End-stage renal disease patients on haemodialysis (HD) have been largely excluded from SARS-CoV-2 vaccine trials due to safety reasons and shown to mount lower responses to vaccination. This study aims to evaluate the immunogenicity and safety of inactivated COVID-19 vaccine among HD patients compared to healthy controls. All subjects who received the primary inactivated COVID-19 vaccination had their blood samples tested 21 days after the second dose. We report the immunogenicity based on anti-RBD IgG titre (IU/mL), the inhibition rate of neutralizing antibodies (NAbs) (%) to RBD, and seroconversion rates. Adverse events were assessed within 30 min and on the 7th day after each dose. Among 75 HD patients and 71 healthy controls, we observed no significant difference in all immunogenicity measures: anti-RBD IgG GMT (277.91 ± 7.13 IU/mL vs. 315.50 ± 3.50 IU/mL, p = 0.645), NAbs inhibition rate (82% [53–96] vs. 84% [39–98], p = 0.654), and seroconversion rates (anti-RBD IgG: 86.7% vs. 85.9%, p = 0.895; NAbs: 45.3% vs. 60.6%, p = 0.065). The number of adverse events is not significantly different between the two groups. The primary inactivated SARS-CoV-2 vaccination elicits an adequate antibody response and can be safely administered in haemodialysis patients. Nature Publishing Group UK 2023-07-18 /pmc/articles/PMC10354113/ /pubmed/37463975 http://dx.doi.org/10.1038/s41598-023-38628-2 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Article
Puspitasari, Metalia
Sattwika, Prenali D.
Rahari, Dzerlina S.
Wijaya, Wynne
Hidayat, Auliana R. P.
Kertia, Nyoman
Purwanto, Bambang
Thobari, Jarir At
Immunogenicity and safety of inactivated SARS-CoV-2 vaccine in haemodialysis patients: a prospective cohort study
title Immunogenicity and safety of inactivated SARS-CoV-2 vaccine in haemodialysis patients: a prospective cohort study
title_full Immunogenicity and safety of inactivated SARS-CoV-2 vaccine in haemodialysis patients: a prospective cohort study
title_fullStr Immunogenicity and safety of inactivated SARS-CoV-2 vaccine in haemodialysis patients: a prospective cohort study
title_full_unstemmed Immunogenicity and safety of inactivated SARS-CoV-2 vaccine in haemodialysis patients: a prospective cohort study
title_short Immunogenicity and safety of inactivated SARS-CoV-2 vaccine in haemodialysis patients: a prospective cohort study
title_sort immunogenicity and safety of inactivated sars-cov-2 vaccine in haemodialysis patients: a prospective cohort study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10354113/
https://www.ncbi.nlm.nih.gov/pubmed/37463975
http://dx.doi.org/10.1038/s41598-023-38628-2
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