Impact of tozinameran (BNT162b2) mRNA vaccine on kidney transplant and chronic dialysis patients: 3–5 months follow-up

Abstract

Background Determining the humoral immunogenicity of tozinameran (BNT162b2) in patients requiring chronic renal replacement therapy, and its impact on COVID-19 morbidity several months after vaccination, may guide risk assessment and changes in vaccination policy. Methods In a prospective post-vaccination cohort study with up to 5 months follow-up we studied outpatient dialysis and kidney transplant patients and respective healthcare teams. Outcomes were anti S1/S2 antibody responses to vaccine or infection, and infection rate during follow-up. Results One hundred seventy-five dialysis patients (40% women, 65 ± 15 years), 252 kidney transplant patients (33% women, 54 ± 14 years) and 71 controls (65% women, 44 ± 14 years) were followed. Three months or longer after vaccination we detected anti S1/S2 IgG antibodies in 79% of dialysis patients, 42% of transplant recipients and 100% of controls, whereas respective rates after infection were 94%, 69% and 100%. Predictors of non-response were older age, diabetes, history of cancer, lower lymphocyte count and lower vitamin-D levels. Factors associated with lower antibody levels in dialysis patients were modality (hemodialysis vs peritoneal) and high serum ferritin levels. In transplant patients, hypertension and higher calcineurin or mTOR inhibitor drug levels were linked with lower antibody response. Vaccination was associated with fewer subsequent infections (HR 0.23, p < 0.05). Moreover, higher antibody levels (particularly above 59 AU/ml) were associated with fewer events, with a HR 0.41 for each unit increased in log 10 titer (p < 0.05). Conclusions Dialysis patients, and more strikingly kidney transplant recipients, mounted reduced antibody response to COVID-19 mRNA vaccination. Lesser humoral response was associated with more infections. Measures to identify and protect non-responsive patients are required. Graphic abstract Supplementary Information The online version contains supplementary material available at 10.1007/s40620-021-01210-y.

Immunogenicity and tolerability of COVID‐19 vaccination in peritoneal dialysis patients—A prospective observational cohort study

“…In our study, a threefold higher spike IgG level was found in medical personnel compared with patients, whereas this ratio was 1.5 times higher in a recent report 16 . SARS‐CoV‐2 spike IgG levels of peritoneal dialysis patients observed in the present study appeared to be similar or higher compared with that recently reported in hemodialysis patients; however in these studies, immunogenicity of vaccines in normal population and tolerability of vaccination in peritoneal dialysis patients or normal population was not reported 17–20 . The results of the present study can be explained, at least in part, by the shorter time between the first and second vaccinations, the different spike IgG assays, and the SARS‐CoV‐2 vaccines used compared with the recent report.…”

Long-Term Humoral Response After a Second Dose of SARS-CoV-2 mRNA Vaccine in Japanese Kidney Transplant Recipients

“…Therefore, only a low mycophenolic acid dose was associated with an appropriate humoral response in KTRs. A high lymphocyte count ( Ben-Dov et al, 2022 ) and fewer types of immunosuppressants ( Grupper et al, 2021 ; Rozen-Zvi et al, 2021 ), are, as would be expected, reportedly associated with the lack of an appropriate humoral immune response. Data on the associations of hemoglobin and BMI with a humoral response in KTRs are sparse.…”

“…In this study, the long-term appropriate humoral response rate was 47.8% and the anti-S SARS-CoV-2 IgG antibody titers was very low at 35.3 (IQR = 3.8 to 159.7) AU/mL at 5 months (149.2 ± 45.5 days) after the second dose. Similarly, the appropriate response rate was 42% in Israel ( Ben-Dov et al, 2022 ). Therefore, third doses should be administered to Japanese KTRs.…”

“…Data on the associations of hemoglobin and BMI with a humoral response in KTRs are sparse. Advanced age, decreased renal function, steroid pulse therapy, diabetes, history of cancer, serum ferritin level, and serum 25(OH)VitD level have also been reported to be associated with an inappropriate humoral immune response ( Grupper et al, 2021 ; Rozen-Zvi et al, 2021 ; Ben-Dov et al, 2022 ). Although these factors were not associated with an appropriate humoral response in this study, analysis of a larger number of cases might have yielded associations.…”

Exploring the Role of Serology Testing to Strengthen Vaccination Initiatives and Policies for COVID-19 in Asia Pacific Countries and Territories: A Discussion Paper

“…There is mounting evidence on the benefits of stratifying individual risk based on antibody levels, especially for immunocompromised individuals [169]. Risk groups that could benefit from such efforts include the elderly [90,170], cancer patients [169,171], hemodialysis patients [172], transplant patients [173,174], and patients on tumor necrosis factor inhibitors, such as inflammatory bowel disease [175], psoriatic arthritis [176], and inflammatory rheumatic diseases [177]. The availability of correlates of protection is a requirement for this use.…”