Humoral Response and SARS-CoV-2 Infection Risk following the Third and Fourth Doses of the BNT162b2 Vaccine in Dialysis Patients

Einbinder, Yael; Perl, Jeffrey; Nacasch, Naomi; Bnaya, Alon; Shavit, Linda; Erez, Daniel; Shashar, Moshe; Halperin, Tami; Grupper, Ayelet; Benchetrit, Sydney; Wand, Ori; Cohen-Hagai, Keren

doi:10.1159/000525309

Cited by 17 publications

(13 citation statements)

References 9 publications

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“…7,8,15,24 However, longer-term studies following the immune response after third doses have so far been limited by sample size and infrequent assessment. 11,12 This study used six months of post-third dose data to show that third doses also improved durability of the immune response. Specifically, among those without history of COVID-19, median [IQR] titer was 150 [42, 471] BAU/mL at six months in the initial series cohort, similar to our prior findings, 4,13 but 1288 [512, ≥ 1781] BAU/mL at six months in the third dose cohort.…”

Section: Discussionmentioning

confidence: 99%

“…The initial augmentation of the immune response by additional vaccine doses is well-established, 7,8 but longer term studies have been limited by small sample size and infrequent monitoring. 11,12 In this study, we used serially collected antibody data to 1) identify previously unrecognized SARS-CoV-2 infections based on an increase in titer, and 2) characterize the trend of antibody titer levels over six months after additional vaccine doses.…”

Section: Introductionmentioning

confidence: 99%

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Serial SARS-CoV-2 antibody titers in vaccinated dialysis patients: prevalence of unrecognized infection and duration of seroresponse

Hsu

Weiner

Manley³

et al. 2023

Preprint

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Rationale & Objective: SARS-CoV-2 infections are likely underdiagnosed, but the degree of underdiagnosis among maintenance dialysis patients is unknown. Durability of the immune response after third vaccine doses in this population also remains uncertain. This study tracked antibody levels to 1) assess the rate of undiagnosed infections and 2) characterize seroresponse durability after third doses. Study Design: Retrospective observational study Setting & Participants: SARS-CoV-2 vaccinated patients receiving maintenance dialysis through a national dialysis provider. Immunoglobulin G spike antibodies (anti-spike IgG) titers were assessed monthly following vaccination. Exposure(s): Two and three doses of SARS-CoV-2 vaccine Outcome(s): Undiagnosed and diagnosed SARS-CoV-2 infections; anti-spike IgG titers over time Analytical Approach: "Undiagnosed" SARS-CoV-2 infections were identified as an increase in anti-spike IgG titer of ≥100 BAU/mL, not associated with receipt of vaccine or "diagnosed" SARS-CoV-2 infection (by PCR or antigen test). In descriptive analyses, anti-spike IgG titers were followed over time. Results: Among 2660 patients without prior COVID-19 who received an initial two-dose vaccine series, 371 (76%) SARS-CoV-2 infections were diagnosed and 115 (24%) were undiagnosed. Among 1717 patients without prior COVID-19 who received a third vaccine dose, 155 (80%) SARS-CoV-2 infections were diagnosed and 39 (20%) were undiagnosed. In both cohorts, anti-spike IgG levels declined over time. Of the initial two-dose cohort, 66% had a titer ≥500 BAU/mL in the first month, with 23% maintaining a titer ≥500 BAU/mL at six months. Of the third dose cohort, 95% had a titer ≥500 BAU/mL in the first month after the third dose, with 76% maintaining a titer ≥500 BAU/mL at six months. Limitations: Assays used had upper limits. Conclusions: Among maintenance dialysis patients, 20-24% of SARS-CoV-2 infections were undiagnosed. Given this population's vulnerability to COVID-19, ongoing infection control measures are needed. A three-dose primary mRNA vaccine series optimizes seroresponse rate and durability.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Serial SARS-CoV-2 antibody titers in vaccinated dialysis patients: prevalence of unrecognized infection and duration of seroresponse

Hsu

Weiner

Manley³

et al. 2023

Preprint

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“…The progressive decrease in antibody titers over time after each vaccination dose is a cause for concern. Previous reports have shown that 3 to 6 months after initial vaccination and booster doses, significant anti-spike titer decline is observed in dialysis patients [ 12 , 24 ]. At present, individualizing additional dose prescriptions is probably the best strategy to obtain an optimal immune response, avoiding the risk of hyperstimulation and immune exhaustion [ 25 , 26 ].…”

Section: Discussionmentioning

confidence: 99%

Long-Term Dynamic Humoral Response to SARS-CoV-2 mRNA Vaccines in Patients on Peritoneal Dialysis

Quiroga

Soler²,

Ortíz³

et al. 2022

Vaccines

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Introduction. Patients on peritoneal dialysis (PD) present an impaired humoral response against SARS-CoV-2, at least after the initial vaccination and booster dose. Until now, the effect of a fourth dose has not been established. The aim of the present study is to evaluate the long-term dynamics of the humoral response of PD patients to multiple doses of SARS-CoV-2 vaccines, focusing on the effect of the fourth dose. Methods. This is an analysis of the prospective and multicentric SENCOVAC study. We included patients on PD without additional immunosuppression that had received at least 3 SARS-CoV-2 mRNA vaccine doses. We evaluated anti-spike antibody titers after the initial vaccination, third and fourth doses, using prespecified fixed assessments (i.e., baseline, 28 days, 3, 6, and 12 months after completing the initial vaccine schedule). Breakthrough infections were also collected. Results. We included 164 patients on PD (69% males, 62 ± 13 years old). In patients who had received only two doses, the rates of positive humoral response progressively decreased from 96% at 28 days to 80% at 6 months, as did with anti-spike antibody titers. At 6 months, 102 (62%) patients had received the third vaccine dose. Patients with the third dose had higher rates of positive humoral response (p = 0.01) and higher anti-spike antibody titers (p < 0.001) at 6 months than those with only 2 doses. At 12 months, the whole cohort had received 3 vaccine doses, and 44 (27%) patients had an additional fourth dose. The fourth dose was not associated to higher rates of positive humoral response (100 vs. 97%, p = 0.466) or to statistically significant differences in anti-spike antibody titers as compared to three doses (p = 0.371) at 12 months. Prior antibody titers were the only predictor for subsequent higher anti-spike antibody titer (B 0.53 [95%CI 0.27–0.78], p < 0.001). The 2 (1.2%) patients that developed COVID-19 during follow-up had mild disease. Conclusions. PD presents an acceptable humoral response with three doses of SARS-CoV-2 vaccines that improve the progressive loss of anti-spike antibody titers following two vaccine doses.

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“…The fourth vaccine dose led to another profound rise in anti-S titres, and the absolute increase following the fourth dose correlated with the response to the third dose in dialysis patients Einbinder et al 49 No adverse events were reported Abbreviation: SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.…”

Section: Bnt162b2mentioning

confidence: 97%

Immunogenicity, clinical efficacy and safety of additional second COVID‐19 booster vaccines against Omicron and its subvariants: A systematic review

Chenchula,

Chandra,

Adusumilli

et al. 2024

Reviews in Medical Virology

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The Omicron variant of severe acute respiratory syndrome coronavirus 2 is a new variant of concern (VOC) and an emerging subvariant that exhibits heightened infectivity, transmissibility, and immune evasion, escalating the incidence of moderate to severe coronavirus disease 2019 (COVID‐19). It resists monoclonal antibodies and diminishes vaccine efficacy. Notably, new sublineages have outpaced earlier predominant sublineages. Although the primary vaccination series and initial boosters were robust against previous VOCs, their efficacy waned against Omicron and its subvariants. In this systematic review, we assessed real‐world evidence on the immunogenicity, clinical efficacy, and safety of a second booster or fourth COVID‐19 vaccine dose against the Omicron VOC and its subvariants. A comprehensive literature search was conducted in Medline/PubMed, Google Scholar, bioRxiv, and medRxiv, and relevant studies published between 2022 and 30 May 2023 were reviewed. We found a total of 40 relevant articles focusing on a second booster dose for COVID‐19, including clinical trials and observational studies, involving 3,972,856 patients. The results consistently revealed that an additional second booster dose restored and prolonged waning immunity, activating both humoral and cellular responses against Omicron and its subvariants. A second booster treatment correlated with enduring protection against COVID‐19, notably preventing substantial symptomatic disease and mortality associated with severe Omicron infection. Both monovalent messenger RNA (mRNA) and nonmRNA vaccines demonstrated similar efficacy and safety, with bivalent mRNA vaccines exhibiting broader protection against emerging subvariants of Omicron. The safety profiles of second booster were favourable with only mild systemic and local symptoms reported in some recipients. In conclusion, this systematic review underscores the additional COVID‐19 vaccine boosters, particularly with bivalent or multivalent mRNA vaccines, for countering the highly infectious emerging subvariants of Omicron.

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Humoral Response and SARS-CoV-2 Infection Risk following the Third and Fourth Doses of the BNT162b2 Vaccine in Dialysis Patients

Cited by 17 publications

References 9 publications

Serial SARS-CoV-2 antibody titers in vaccinated dialysis patients: prevalence of unrecognized infection and duration of seroresponse

Serial SARS-CoV-2 antibody titers in vaccinated dialysis patients: prevalence of unrecognized infection and duration of seroresponse

Long-Term Dynamic Humoral Response to SARS-CoV-2 mRNA Vaccines in Patients on Peritoneal Dialysis

Immunogenicity, clinical efficacy and safety of additional second COVID‐19 booster vaccines against Omicron and its subvariants: A systematic review

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