{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T01:42:09Z","timestamp":1760060529766,"version":"build-2065373602"},"reference-count":28,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003197","name":"Italian Medicines Agency","doi-asserted-by":"publisher","award":["CA10","CCM 2020"],"award-info":[{"award-number":["CA10","CCM 2020"]}],"id":[{"id":"10.13039\/501100003197","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Italian Ministry of Health","award":["CA10","CCM 2020"],"award-info":[{"award-number":["CA10","CCM 2020"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Background: COVID-19 vaccination and subsequent booster doses became critical components of public health strategies to control the pandemic and reduce disease severity, especially in fragile individuals. Among these, subjects undergoing dialysis represent one of the highly vulnerable populations. Methods: We conducted a multicenter case\u2013control study among dialysis patients between March 2021 and May 2022 (study population n = 3264). We evaluated anti-S\/RBD-IgG and anti-SARS-CoV-2 neutralizing antibodies before (T3) and after (T4) the third dose in individuals with a COVID-19 diagnosis after the third dose (cases) and in those who did not report infection (controls). Results: The study included 187 cases and 150 controls. Serological analysis showed a significant increase (p &lt; 0.001) in anti-SARS-CoV-2 antibody levels after the third vaccine dose (from T3 to T4) in both groups. At T3, with the same number of days between the second dose and T3, the antibody levels detected were significantly lower in cases as compared to controls. At T4, we observed similar antibody titers in the two groups. Notably, the mean difference in time from the third dose to T4 was significantly greater in controls (73.0 days vs. 36.7, p &lt; 0.001), suggesting a reduced antibody waning in controls. Accordingly, multivariate analysis showed that the risk of infection was considerably reduced by the pre-third-dose antibody levels. Conclusions: This study reinforces the critical role of the humoral response in preventing infections in the vulnerable population of dialysis patients. Regular monitoring of antibody levels and timely administration of booster doses are essential to optimize protection in this group.<\/jats:p>","DOI":"10.3390\/vaccines13090935","type":"journal-article","created":{"date-parts":[[2025,9,2]],"date-time":"2025-09-02T16:05:22Z","timestamp":1756829122000},"page":"935","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Humoral Response to the Third Dose of SARS-CoV-2 Vaccine Among Dialysis Patients: A Breakthrough Infection Case\u2013Control Study"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0640-8667","authenticated-orcid":false,"given":"Francesca","family":"Colavita","sequence":"first","affiliation":[{"name":"Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani, IRCCS, 00149 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9819-236X","authenticated-orcid":false,"given":"Concetta","family":"Castilletti","sequence":"additional","affiliation":[{"name":"Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, 37024 Verona, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2948-4243","authenticated-orcid":false,"given":"Giulia","family":"Matusali","sequence":"additional","affiliation":[{"name":"Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani, IRCCS, 00149 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1857-1429","authenticated-orcid":false,"given":"Silvia","family":"Accordini","sequence":"additional","affiliation":[{"name":"Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, 37024 Verona, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5889-9280","authenticated-orcid":false,"given":"Salvatore","family":"De Masi","sequence":"additional","affiliation":[{"name":"Clinical Trial Centre, Careggi Hospital, 50134 Florence, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roberto","family":"Da Cas","sequence":"additional","affiliation":[{"name":"Italian National Institute of Health, 00161 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natasha","family":"Gianesini","sequence":"additional","affiliation":[{"name":"Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, 37024 Verona, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8313-794X","authenticated-orcid":false,"given":"Giovanni","family":"Baglio","sequence":"additional","affiliation":[{"name":"Italian National Agency for Regional Healthcare Services, 00187 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3133-9237","authenticated-orcid":false,"given":"Massimo","family":"Francalancia","sequence":"additional","affiliation":[{"name":"Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani, IRCCS, 00149 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giuseppe","family":"Traversa","sequence":"additional","affiliation":[{"name":"Italian National Institute of Health, 00161 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Flavia","family":"Chiarotti","sequence":"additional","affiliation":[{"name":"Italian National Institute of Health, 00161 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0924-993X","authenticated-orcid":false,"given":"Silvia","family":"Meschi","sequence":"additional","affiliation":[{"name":"Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani, IRCCS, 00149 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elvira","family":"Bianco","sequence":"additional","affiliation":[{"name":"Careggi Hospital, 50134 Florence, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mario","family":"Salomone","sequence":"additional","affiliation":[{"name":"Unit of Nephrology and Dialysis, Chieri and Moncalieri Hospitals, 10024 Turin, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alfonso","family":"Mele","sequence":"additional","affiliation":[{"name":"Italian National Institute of Health, 00161 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Piergiorgio","family":"Messa","sequence":"additional","affiliation":[{"name":"Unit of Nephrology, Dialysis, and Renal Transplant, Fondazione IRCCS Ca\u2019 Granda Ospedale Maggiore Policlinico, 20162 Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carmine","family":"Zoccali","sequence":"additional","affiliation":[{"name":"Renal Research Institute, New York, NY 10065, USA"},{"name":"Istituto di Biologia e Genetica Molecolare (BIOGEM), 83031 Ariano Irpino, Italy"},{"name":"Associazione Ipertensione, Nefrologia e Trapianto Renale (IPNET) c\/o Nefrologia, Grande Ospedale Metropolitano, 89133 Reggio Calabria, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesca","family":"Menniti Ippolito","sequence":"additional","affiliation":[{"name":"Italian National Institute of Health, 00161 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"the COVIDVaxDia Study Group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,9,1]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1540","DOI":"10.1016\/j.kint.2020.09.006","article-title":"Results from the ERA-EDTA Registry Indicate a High Mortality Due to COVID-19 in Dialysis Patients and Kidney Transplant Recipients across Europe","volume":"98","author":"Jager","year":"2020","journal-title":"Kidney Int."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"883","DOI":"10.1016\/j.kint.2022.01.022","article-title":"COVID-19 in Dialysis: Clinical Impact, Immune Response, Prevention, and Treatment","volume":"101","year":"2022","journal-title":"Kidney Int."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"291","DOI":"10.1038\/s41581-021-00406-6","article-title":"COVID-19 Vaccines and Kidney Disease","volume":"17","author":"Windpessl","year":"2021","journal-title":"Nat. Rev. Nephrol."},{"key":"ref_4","doi-asserted-by":"crossref","unstructured":"Yap, D.Y.-H., Fong, C.H.-Y., Zhang, X., Ip, J.D., Chan, W.-M., Chu, A.W.-H., Chen, L.-L., Zhao, Y., Chan, B.P.-C., and Luk, K.S. (2023). Humoral and Cellular Immunity against Different SARS-CoV-2 Variants in Patients with Chronic Kidney Disease. Sci. Rep., 13.","DOI":"10.1038\/s41598-023-47130-8"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"1947","DOI":"10.1093\/ndt\/gfab224","article-title":"COVID-19 Vaccination in Haemodialysis Patients: Good Things Come in Threes\u2026","volume":"36","author":"Frantzen","year":"2021","journal-title":"Nephrol. Dial. Transplant."},{"key":"ref_6","doi-asserted-by":"crossref","unstructured":"Liao, B.-H., Platen, L., Grommes, M., Cheng, C.-C., Holzmann-Littig, C., Christa, C., Haller, B., Kappler, V., Bester, R., and Werz, M.L. (2024). SARS-CoV-2 Neutralization Capacity in Hemodialysis Patients with and without a Fifth Vaccination with the Updated Comirnaty Original\/Omicron BA.4-5 Vaccine. Vaccines, 12.","DOI":"10.3390\/vaccines12030308"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"390","DOI":"10.1093\/ndt\/gfab299","article-title":"Humoral Response after SARS-CoV-2 Vaccination in Patients Undergoing Maintenance Haemodialysis: Loss of Immunity, Third Dose and Non-Responders","volume":"37","author":"Robert","year":"2022","journal-title":"Nephrol. Dial. Transplant."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"586","DOI":"10.1159\/000525309","article-title":"Humoral Response and SARS-CoV-2 Infection Risk following the Third and Fourth Doses of the BNT162b2 Vaccine in Dialysis Patients","volume":"53","author":"Einbinder","year":"2022","journal-title":"Am. J. Nephrol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"207","DOI":"10.1159\/000521676","article-title":"Humoral Response to Pfizer BNT162b2 Vaccine Booster in Maintenance Hemodialysis Patients","volume":"53","author":"Shashar","year":"2022","journal-title":"Am. J. Nephrol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"185","DOI":"10.1053\/j.ajkd.2021.08.005","article-title":"SARS-CoV-2 Antibody Response After a Third Dose of the BNT162b2 Vaccine in Patients Receiving Maintenance Hemodialysis or Peritoneal Dialysis","volume":"79","author":"Bensouna","year":"2022","journal-title":"Am. J. Kidney Dis."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"185","DOI":"10.1159\/000525519","article-title":"Humoral Response to the Third Dose of BNT162b2 COVID-19 Vaccine among Hemodialysis Patients","volume":"147","author":"Agur","year":"2023","journal-title":"Nephron"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"559","DOI":"10.1159\/000524658","article-title":"Waning of SARS-CoV-2 Vaccine-Induced Immune Response over 6 Months in Peritoneal Dialysis Patients and the Role of a Booster Dose in Maintaining Seropositivity","volume":"146","author":"Murt","year":"2022","journal-title":"Nephron"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"107","DOI":"10.1159\/000536308","article-title":"Immunogenicity and Safety of the Three-Dose COVID-19 Vaccine Regimen in Patients Receiving Renal Replacement Therapy: A Systematic Review and Meta-Analysis","volume":"10","author":"Ma","year":"2024","journal-title":"Kidney Dis."},{"key":"ref_14","doi-asserted-by":"crossref","unstructured":"Ponce, P., Peralta, R., Felix, C., Pinto, C., Pinto, B., and Matos, J.F. (2022). Vaccination against SARS-CoV-2 in Haemodialysis Patients: Spike\u2019s Ab Response and the Influence of BMI and Age. Int. J. Environ. Res. Public Health, 19.","DOI":"10.3390\/ijerph191610091"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"676","DOI":"10.1016\/j.nefro.2022.12.006","article-title":"Lessons from SENCOVAC: A Prospective Study Evaluating the Response to SARS-CoV-2 Vaccination in the CKD Spectrum","volume":"43","author":"Quiroga","year":"2023","journal-title":"Nefrolog\u00eda"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1138","DOI":"10.1038\/sj.ki.5002425","article-title":"Uremia Impairs Monocyte and Monocyte-Derived Dendritic Cell Function in Hemodialysis Patients","volume":"72","author":"Lim","year":"2007","journal-title":"Kidney Int."},{"key":"ref_17","doi-asserted-by":"crossref","unstructured":"Mink, S., and Fraunberger, P. (2023). Anti-SARS-CoV-2 Antibody Testing: Role and Indications. J. Clin. Med., 12.","DOI":"10.3390\/jcm12247575"},{"key":"ref_18","unstructured":"Italian Ministry of Health (2025, July 15). Circolare del Ministero della Salute No. 45886 del 8 Ottobre, Available online: https:\/\/3.flcgil.stgy.it\/files\/pdf\/20211011\/circolare-ministeriale-45886-dell-8-ottobre-2021-aggiornamento-indicazioni-sulla-somministrazione-di-dosi-addizionali-e-di-dosi-booster-nell-ambito-della-campagna-di-vaccinazione-anti-sars-cov-2-covid-19.pdf."},{"key":"ref_19","unstructured":"(GU Serie Generale n.72 del 24-03-2021, 2021). Piano strategico nazionale dei vaccini per la prevenzione delle infezioni da SARS-CoV-2. Raccomandazioni ad interim sui gruppi Tatget della vaccinazione anti SARS-CoV-2\/COVID-19, GU Serie Generale n.72 del 24-03-2021."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"2013","DOI":"10.1007\/s40620-023-01708-7","article-title":"Safety and Efficacy of COVID-19 Vaccines in Patients on Dialysis: A Multicentre Cohort Study in Italy","volume":"36","author":"Mele","year":"2023","journal-title":"J. Nephrol."},{"key":"ref_21","doi-asserted-by":"crossref","unstructured":"Ciabattini, A., Pettini, E., Fiorino, F., Polvere, J., Lucchesi, S., Coppola, C., Costagli, S., Pastore, G., Sicuranza, A., and Tozzi, M. (2025). Longitudinal Immunogenicity Cohort Study of SARS-CoV-2 MRNA Vaccines across Individuals with Different Immunocompromising Conditions: Heterogeneity in the Immune Response and Crucial Role of Omicron-Adapted Booster Doses. eBioMedicine, 113.","DOI":"10.1016\/j.ebiom.2025.105577"},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"e145","DOI":"10.1016\/S1473-3099(23)00783-1","article-title":"Immune Responses Following BNT162b2 XBB.1.5 Vaccination in Patients on Haemodialysis in Germany","volume":"24","author":"Cossmann","year":"2024","journal-title":"Lancet Infect. Dis."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"29","DOI":"10.1146\/annurev-immunol-083122-043054","article-title":"SARS-CoV-2: The Interplay Between Evolution and Host Immunity","volume":"43","author":"Case","year":"2025","journal-title":"Annu. Rev. Immunol."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"1871","DOI":"10.1007\/s40620-024-02007-5","article-title":"Impact of COVID-19 vaccines in patients on hemodialysis: An Italian multicentre cohort study","volume":"37","author":"Baglio","year":"2024","journal-title":"J. Nephrol."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"966","DOI":"10.1038\/s41590-023-01508-y","article-title":"Robust and Prototypical Immune Responses toward COVID-19 Vaccine in First Nations Peoples Are Impacted by Comorbidities","volume":"24","author":"Zhang","year":"2023","journal-title":"Nat. Immunol."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"950","DOI":"10.1056\/NEJMc2216309","article-title":"Immunologic Effect of Bivalent MRNA Booster in Patients Undergoing Hemodialysis","volume":"388","author":"Huth","year":"2023","journal-title":"N. Engl. J. Med."},{"key":"ref_27","doi-asserted-by":"crossref","unstructured":"Tometten, I., Brandt, T., Schlotz, M., Stumpf, R., Landmann, S., Kantauskaite, M., Lamberti, J., Hillebrandt, J., M\u00fcller, L., and Kittel, M. (2025). Comparison of Immune Responses to SARS-CoV-2 Spike Following Omicron Infection or Omicron BA.4\/5 Vaccination in Kidney Transplant Recipients. Front. Immunol., 15.","DOI":"10.3389\/fimmu.2024.1476294"},{"key":"ref_28","doi-asserted-by":"crossref","unstructured":"Matusali, G., Colavita, F., Lapa, D., Meschi, S., Bordi, L., Piselli, P., Gagliardini, R., Corpolongo, A., Nicastri, E., and Antinori, A. (2021). SARS-CoV-2 Serum Neutralization Assay: A Traditional Tool for a Brand-New Virus. Viruses, 13.","DOI":"10.3390\/v13040655"}],"container-title":["Vaccines"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2076-393X\/13\/9\/935\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T18:37:22Z","timestamp":1760035042000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2076-393X\/13\/9\/935"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,1]]},"references-count":28,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2025,9]]}},"alternative-id":["vaccines13090935"],"URL":"https:\/\/doi.org\/10.3390\/vaccines13090935","relation":{},"ISSN":["2076-393X"],"issn-type":[{"type":"electronic","value":"2076-393X"}],"subject":[],"published":{"date-parts":[[2025,9,1]]}}}