Immunogenicity of a first dose of mRNA- or vector-based SARS-CoV-2 vaccination in dialysis patients: a multicenter prospective observational pilot study

Lesny, Paul; Anderson, Mark; Cloherty, Gavin; Stec, Michael; Haase-Fielitz, Anja; Haarhaus, Mathias; Santos, Carla; Lucas, Carlos; Macário, Fernando; Haase, Michael

doi:10.1007/s40620-021-01076-0

Cited by 28 publications

(48 citation statements)

References 10 publications

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“…Prospective studies with other vaccines against COVID-19, e.g., viral vectorbased vaccines, will help to elucidate the efficacy of different vaccines in these patients. Moreover, antibody titer persistence in patients on dialysis might differ from otherwise healthy persons, which should be addressed in longitudinal observations (25).…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity of COVID-19 Tozinameran Vaccination in Patients on Chronic Dialysis

et al. 2021

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Patients with kidney failure have notoriously weak responses to common vaccines. Thus, immunogenicity of novel SARS-CoV-2 vaccines might be impaired in this group. To determine immunogenicity of SARS-CoV-2 vaccination in patients with chronic dialysis, we analyzed the humoral and T-cell response after two doses of mRNA vaccine Tozinameran (BNT162b2 BioNTech/Pfizer). This observational study included 43 patients on dialysis before vaccination with two doses of Tozinameran 21 days apart. Overall, 36 patients completed the observation period until three weeks after the second dose and 32 patients were further analyzed at week 10. Serum samples were analyzed by SARS-CoV-2 specific IgG and IgA antibodies ~1, ~3–4 and ~10 weeks after the second vaccination. In addition, SARS-CoV-2-specific T-cell responses were assessed at ~3–4 weeks by an interferon-gamma release assay (IGRA). Antibody and T cell outcomes at this timepoint were compared to a group of 44 elderly patients not on dialysis, after immunization with Tozinameran. Median age of patients on chronic dialysis was 74.0 years (IQR 66.0, 82.0). The proportion of males was higher (69.4%) than females. Only 20/36 patients (55.6%, 95%CI: 38.29–71.67) developed SARS-CoV-2-IgG antibodies at the first sampling, whereas 32/36 patients (88.9%, 95%CI: 73.00–96.38) demonstrated IgG detection at the second sampling. In a longitudinal follow-up at ~10 weeks after the second dose, the proportion of dialysis patients reactive for anti-SARS-CoV-2-IgG decreased to 27/32 (84.37%, 95%CI: 66.46–94.10) The proportion of anti-SARS-CoV-2 S1 IgA decreased from 33/36 (91.67%; 95%CI: 76.41–97.82) at weeks 3–4 down to 19/32 (59.38; 95%CI: 40.79–75.78). Compared to a cohort of vaccinees with similar age but not on chronic dialysis seroconversion rates and antibody titers were significantly lower. SARS-CoV-2-specific T-cell responses 3 weeks after second vaccination were detected in 21/31 vaccinated dialysis patients (67.7%, 95%CI: 48.53–82.68) compared to 42/44 (93.3%, 95%CI: 76.49–98.84) in controls of similar age. Patients on dialysis demonstrate a delayed, but robust immune response three to four weeks after the second dose, which indicates effective vaccination of this vulnerable group. However, the lower immunogenicity of Tozinameran in these patients needs further attention to develop potential countermeasures such as an additional booster vaccination.

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Section: Discussionmentioning

confidence: 99%

Immunogenicity of COVID-19 Tozinameran Vaccination in Patients on Chronic Dialysis

et al. 2021

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“…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.…”

Section: Study Characteristicsmentioning

confidence: 99%

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

et al. 2021

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IMPORTANCE Adults receiving dialysis treatment have a higher likelihood of death when infected with SARS-CoV-2 than adults not receiving dialysis treatment. To date, the immune response of people receiving dialysis after SARS-CoV-2 vaccination has not been systematically discussed.OBJECTIVE To assess immunogenicity rates in people with end-stage kidney disease (ESKD) receiving SARS-CoV-2 vaccines, explore postvaccination potential risk factors for nonresponse, and assess whether receiving dialysis is associated with different antibody response rates compared with the nondialysis population.DATA SOURCES This systematic review and meta-analysis used articles from PubMed, Medline, and Embase published before July 30, 2021, as well as articles in the medRxiv preprint server. STUDY SELECTIONStudies that evaluated the immunogenicity rate according to the postvaccine antibody response rate in patients with ESKD receiving dialysis were selected. DATA EXTRACTION AND SYNTHESISThe meta-analysis was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline. A random-effects model was used. Two independent reviewers conducted the literature search and extracted the data. MAIN OUTCOMES AND MEASURESThe primary outcome was the pooled antibody postvaccine response rates in individuals with ESKD. The secondary outcomes were pooled response rates in individuals receiving and not receiving dialysis. Subgroup analysis and meta-regression were conducted to identify the sources of heterogeneity. RESULTSA total of 32 studies were included. The overall immunogenicity rate of the dialysis group was 86% (95% CI, 81%-89%). Meta-regression showed a significant difference was detected in the postvaccine response rate on the basis of prevalence of diabetes (regression coefficient, −0.06; 95% CI, −0.10 to −0.02; P = .004). Compared with nondialysis controls, patients in the dialysis group had a lower response rate after the first (relative risk [RR], 0.61; 95% CI, 0.47-0.79; I 2 = 70.2%) and second (RR, 0.88; 95% CI, 0.82-0.93; I 2 = 72.2%) doses, with statistically significantly increased RR between first and second doses (P = .007). CONCLUSIONS AND RELEVANCEThese findings suggest that the immunogenicity rate among patients receiving dialysis was 41% after the first dose and 89% after the second dose. Diabetes might be a risk factor for nonresponse in the dialysis population. Patients receiving dialysis had a poorer antibody response rate than did individuals not receiving dialysis, particularly after the first dose.

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“…However, most previous studies have compared the effectiveness of vaccines according to the humoral response to SARS-CoV-2, and therefore, studies focusing on the cellular immune response following COVID-19 vaccination are warranted. On the other hand, most studies have shown the effectiveness of BNT162b2, although one study reported no significant difference in antibody response compared to AZD1222 [ 45 ]. More studies exploring the effectiveness of inactivated whole virus vaccines, viral vector vaccines, other mRNA vaccines, protein subunit vaccines, and mixed prime-boost schedules are also required.…”

Section: Effectiveness Of Covid-19 Vaccines In Hemodialysis Patientsmentioning

confidence: 99%

COVID-19 Vaccines in Patients with Maintenance Hemodialysis

Yen

Lin

Chen

et al. 2021

JPM

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The COVID-19 pandemic has infected more than 180 million people and caused more than 3.95 million deaths worldwide. In addition to personal hygiene, augmented cleaning, social distancing, and isolation, vaccine development and immunization are essential for this highly contagious disease. Patients with maintenance hemodialysis (MHD) have a greater risk of COVID-19 infection owing to their comorbidities, defective immunity, and repeated crowded in-center dialysis settings. However, many patients hesitate to get vaccinated because of their misunderstandings. The Efficacy of COVID-19 vaccination has been intensively discussed in the general population, whereas the data concerning the effectiveness of vaccination in MHD patients are relatively scanty. Nevertheless, those limited publications can provide some valuable information. Overall, lower and more delayed antibody responses following COVID-19 vaccination were observed in patients with MHD than in healthy controls in the settings of different populations, vaccines and dosage, definitions of the immune response, and antibody detection timepoints. Younger age, previous COVID-19 infection, and higher serum albumin level were positively associated with antibody formation, whereas older age and receiving immunosuppressive therapy were unfavorable factors. However, it remains uncertain between the elicited antibodies following vaccination and the genuine protection against COVID-19 infection. Patients with MHD should make their COVID-19 vaccination a priority in addition to other protective measures. More studies focusing on different vaccines, non-humoral immune responses, and risk-benefit analyses are warranted.

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Immunogenicity of a first dose of mRNA- or vector-based SARS-CoV-2 vaccination in dialysis patients: a multicenter prospective observational pilot study

Cited by 28 publications

References 10 publications

Immunogenicity of COVID-19 Tozinameran Vaccination in Patients on Chronic Dialysis

Immunogenicity of COVID-19 Tozinameran Vaccination in Patients on Chronic Dialysis

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

COVID-19 Vaccines in Patients with Maintenance Hemodialysis

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