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The Safety and Immunogenicity of the mRNA-BNT162b2 SARS-CoV-2 Vaccine in Hemodialysis Patients.
Front Immunol. 2021; 12:704773.FI

Abstract

Background

Hemodialysis patients are at high risk for severe COVID-19. SARS-CoV-2 vaccination related safety and immunogenicity data in these patients are rare.

Methods

In this observational study SARS-CoV-2-seronegative hemodialysis patients were vaccinated with two doses of the Pfizer/BioNTech mRNA-BNT162b2 vaccine (COMIRNATY® 30 µg) and followed for 90 days. Local and systemic side effects were assessed at every dialysis session during the first post-vaccination week after the first and second vaccine dose. Immunogenicity was determined four weeks after vaccination by quantifying anti-SARS-CoV-2 spike protein IgG antibodies (LIAISON® SARS-CoV-2-TrimericS IgG chemiluminescent immunoassay) expressed in binding activity units per milliliter (BAU/mL) adapted to the WHO International standard.

Results

Fifty patients (32% women, 68% men) with a mean (SD) age of 67.6 (14.8) years were included. Mild local reactions occurred in 38% after the first injection, and in 29.2% with mild, in 2.1% with moderate and in 2.1% with severe degree after the second injection. Systemic reactive events occurred less often, with diarrhea (4% mild, 4% moderate) and fatigue (8% mild) being the most frequent ones. After the first injection 42% of the patients developed a positive response using the assay specific cut-off value of 33.8 binding activity units per milliliter (BAU/mL) with a median (Q1, Q3) anti-SARS-CoV-2 spike IgG concentration of 20.0 (11.7, 51.0) BAU/mL. After the second injection the percentage of seropositive patients increased to 97.9% with an anti-SARS-CoV-2 spike IgG concentration of 1075 (290.8, 1735) BAU/mL. Higher age and immunosuppression were associated with lower, calcitriol treatment and prior seroconversion to hepatitis B vaccination with significantly higher antibody concentration.

Conclusions

The mRNA-BNT162b2 SARS-CoV-2 vaccine appears to be safe and well-tolerated and shows a high immunogenicity in hemodialysis patients.

Authors+Show Affiliations

Department of Internal Medicine 3 (Nephrology and Dialysis), Feldkirch Academic Teaching Hospital, Feldkirch, Austria. Vorarlberg Institute for Vascular Investigation and Treatment (VIVIT), Feldkirch, Austria. Agency for Preventive and Social Medicine (aks), Bregenz, Austria.Department of Internal Medicine 3 (Nephrology and Dialysis), Feldkirch Academic Teaching Hospital, Feldkirch, Austria.Department of Internal Medicine 3 (Nephrology and Dialysis), Feldkirch Academic Teaching Hospital, Feldkirch, Austria.Department of Internal Medicine 3 (Nephrology and Dialysis), Feldkirch Academic Teaching Hospital, Feldkirch, Austria.Department of Internal Medicine 1, Feldkirch Academic Teaching Hospital, Feldkirch, Austria.Department of Medical Statistics, Informatics and Health Economics, Innsbruck Medical University, Innsbruck, Austria.Department of Internal Medicine 2, Feldkirch Academic Teaching Hospital, Feldkirch, Austria.Department of Internal Medicine 3 (Nephrology and Dialysis), Feldkirch Academic Teaching Hospital, Feldkirch, Austria.Department of Internal Medicine 2, Feldkirch Academic Teaching Hospital, Feldkirch, Austria.Department of Internal Medicine 3 (Nephrology and Dialysis), Feldkirch Academic Teaching Hospital, Feldkirch, Austria. Vorarlberg Institute for Vascular Investigation and Treatment (VIVIT), Feldkirch, Austria.

Pub Type(s)

Journal Article
Observational Study

Language

eng

PubMed ID

34220867

Citation

Zitt, Emanuel, et al. "The Safety and Immunogenicity of the mRNA-BNT162b2 SARS-CoV-2 Vaccine in Hemodialysis Patients." Frontiers in Immunology, vol. 12, 2021, p. 704773.
Zitt E, Davidovic T, Schimpf J, et al. The Safety and Immunogenicity of the mRNA-BNT162b2 SARS-CoV-2 Vaccine in Hemodialysis Patients. Front Immunol. 2021;12:704773.
Zitt, E., Davidovic, T., Schimpf, J., Abbassi-Nik, A., Mutschlechner, B., Ulmer, H., Benda, M. A., Sprenger-Mähr, H., Winder, T., & Lhotta, K. (2021). The Safety and Immunogenicity of the mRNA-BNT162b2 SARS-CoV-2 Vaccine in Hemodialysis Patients. Frontiers in Immunology, 12, 704773. https://doi.org/10.3389/fimmu.2021.704773
Zitt E, et al. The Safety and Immunogenicity of the mRNA-BNT162b2 SARS-CoV-2 Vaccine in Hemodialysis Patients. Front Immunol. 2021;12:704773. PubMed PMID: 34220867.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Safety and Immunogenicity of the mRNA-BNT162b2 SARS-CoV-2 Vaccine in Hemodialysis Patients. AU - Zitt,Emanuel, AU - Davidovic,Tamara, AU - Schimpf,Judith, AU - Abbassi-Nik,Armin, AU - Mutschlechner,Beatrix, AU - Ulmer,Hanno, AU - Benda,Magdalena A, AU - Sprenger-Mähr,Hannelore, AU - Winder,Thomas, AU - Lhotta,Karl, Y1 - 2021/06/16/ PY - 2021/05/03/received PY - 2021/06/02/accepted PY - 2021/7/5/entrez PY - 2021/7/6/pubmed PY - 2021/7/15/medline KW - BNT162b2 KW - COVID-19 KW - SARS-CoV-2 KW - hemodialysis KW - mRNA vaccine SP - 704773 EP - 704773 JF - Frontiers in immunology JO - Front Immunol VL - 12 N2 - Background: Hemodialysis patients are at high risk for severe COVID-19. SARS-CoV-2 vaccination related safety and immunogenicity data in these patients are rare. Methods: In this observational study SARS-CoV-2-seronegative hemodialysis patients were vaccinated with two doses of the Pfizer/BioNTech mRNA-BNT162b2 vaccine (COMIRNATY® 30 µg) and followed for 90 days. Local and systemic side effects were assessed at every dialysis session during the first post-vaccination week after the first and second vaccine dose. Immunogenicity was determined four weeks after vaccination by quantifying anti-SARS-CoV-2 spike protein IgG antibodies (LIAISON® SARS-CoV-2-TrimericS IgG chemiluminescent immunoassay) expressed in binding activity units per milliliter (BAU/mL) adapted to the WHO International standard. Results: Fifty patients (32% women, 68% men) with a mean (SD) age of 67.6 (14.8) years were included. Mild local reactions occurred in 38% after the first injection, and in 29.2% with mild, in 2.1% with moderate and in 2.1% with severe degree after the second injection. Systemic reactive events occurred less often, with diarrhea (4% mild, 4% moderate) and fatigue (8% mild) being the most frequent ones. After the first injection 42% of the patients developed a positive response using the assay specific cut-off value of 33.8 binding activity units per milliliter (BAU/mL) with a median (Q1, Q3) anti-SARS-CoV-2 spike IgG concentration of 20.0 (11.7, 51.0) BAU/mL. After the second injection the percentage of seropositive patients increased to 97.9% with an anti-SARS-CoV-2 spike IgG concentration of 1075 (290.8, 1735) BAU/mL. Higher age and immunosuppression were associated with lower, calcitriol treatment and prior seroconversion to hepatitis B vaccination with significantly higher antibody concentration. Conclusions: The mRNA-BNT162b2 SARS-CoV-2 vaccine appears to be safe and well-tolerated and shows a high immunogenicity in hemodialysis patients. SN - 1664-3224 UR - https://www.unboundmedicine.com/medline/citation/34220867/The_Safety_and_Immunogenicity_of_the_mRNA_BNT162b2_SARS_CoV_2_Vaccine_in_Hemodialysis_Patients_ L2 - https://doi.org/10.3389/fimmu.2021.704773 DB - PRIME DP - Unbound Medicine ER -