The Humoral Response to the BNT162b2 Vaccine in Hemodialysis Patients

Abstract

Importance: Hemodialysis patients have an exceptionally high mortality from COVID-19 and this patient population often has a poor response to vaccinations. Randomized controlled trials for COVID-19 vaccines included few patients with kidney disease, therefore vaccine immunogenicity is uncertain in this population. Objective: Evaluate the SARS-CoV-2 antibody response in chronic hemodialysis patients following one versus two doses of BNT162b2 COVID-19 vaccination compared to health care worker controls and convalescent serum. Design: Prospective observational cohort study. Setting: Single centre study in Toronto, Ontario, Canada. Participants: 142 in-centre hemodialysis patients and 35 health care worker controls. Exposure: BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine. Main Outcomes and Measures: SARS-CoV-2 IgG antibodies to the spike protein (anti-spike), receptor binding domain (anti-RBD), and nucleocapsid protein (anti-NP) were measured in 66 hemodialysis patients receiving one vaccine dose following a public health policy change, 76 patients receiving two vaccine doses, and 35 health care workers receiving two vaccine doses. Results: Detectable anti-NP suggestive of natural SARS-CoV-2 infection was detected in 15/142 (11%) of patients at baseline while only three patients had prior RT-PCR confirmed COVID-19. Two additional patients contracted COVID-19 after receiving two doses of vaccine. In patients receiving a single BNT162b2 dose, seroconversion occurred in 53/66 (80%) for anti-spike and 35/66 (55%) for anti-RBD by 28 days post dose, but only 15/66 (23%) and 4/66 (6%), respectively attained a robust response as defined by reaching the median level of anti-spike and anti-RBD in convalescent serum from COVID-19 survivors. In patients receiving two doses of BNT162b2 vaccine, seroconversion occurred in 69/72 (96%) for anti-spike and 63/72 (88%) for anti-RBD by 2 weeks following the second dose while 52/72 (72%) and 43/76 (41%) reached the median convalescent serum level of anti-spike and anti-RBD, respectively. In contrast, 35/35 (100%) of health care workers exceeded the median level of anti-spike and anti-RBD found in convalescent serum 2-4 weeks after the second dose. Conclusions and Relevance: This study confirms poor immunogenicity 28 days following a single dose of BNT162b2 vaccine in the hemodialysis population, supporting adherence to recommended vaccination schedules, and avoiding delay of the second dose in these at-risk individuals.

Waning Humoral Response 6 Month after Double Vaccination with the mRNA-BNT162b2 Vaccine in Hemodialysis Patients

“…In the HDP population, presented in the current study, the seroconversion rates at 2 months after the second vaccine dose was similar to previous reports [18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33]. Initial studies demonstrated a substantial humoral response in the dialysis population, with seroconversion rates as high as 96%, though levels of antibody titers were significantly lower and more delayed compared to healthy controls [18][19][20][21][22][23][24][25][26]34]. Direct comparison of antibody titers at month 2 to those reported in previous studies is difficult, because different antibody assays were used with different definition of the immune response, titers assessed at different time points (mostly within a month after vaccination).…”

“…In the HDP population, presented in the current study, the seroconversion rates at 2 months after the second vaccine dose was similar to previous reports [18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33]. Initial studies demonstrated a substantial humoral response in the dialysis population, with seroconversion rates as high as 96%, though levels of antibody titers were significantly lower and more delayed compared to healthy controls [18][19][20][21][22][23][24][25][26]34].…”

Immunogenicity Rates After SARS-CoV-2 Vaccination in People With End-stage Kidney Disease

“…After the titles and abstracts were screened, the full texts were reviewed to further determine study eligibility. After the exclusion of irrelevant studies, including studies not addressing the outcome of interest and studies only based on ESKD with kidney transplant population, 32 studies, including 6 preprint articles, were included in the meta-analysis (eFigure 1 in the Supplement). The extracted data are summarized in Table 1 and Table 2.…”

“…Six preprint articles were selected from the medRxiv server and another 5 studies from enrolled studies only reported the immunogenicity rates of patients receiving dialysis who did not complete the vaccination protocol (ie, those who received only 1 dose of the BNT162b, AZD1222, or mRNA-1273 vaccines). 7,[11][12][13]37 Other articles reported an antibody response rate after the second dose with or without reporting the response rate after the first dose. Three studies discussed immunogenicity rates after the booster shot.…”

Immunogenicity of COVID‐19 mRNA vaccines in hemodialysis patients: Systematic review and meta‐analysis

“…I G U R E 1 Flowchart of article identification and selection in the meta-analysisT A B L E 1 Antibody response data in dialysis patients after the first dose of mRNA vaccines(8,(12)(13)(14)(15) …”