Waning Humoral Response after COVID-19 mRNA Vaccination in Maintenance Dialysis Patients and Recovery after a Complementary Third Dose.

The aim of this study was to analyze the waning of anti-spike (S) antibodies after mRNA vaccination against COVID-19 in maintenance dialysis patients, and to assess the safety and effectiveness of the complementary third dose. This was a prospective, longitudinal study in which we analyzed the kinetics of antibodies up to six months after a two-dose vaccination (first protocol) in infection-naïve dialysis patients (IN-Ds), previously infected dialysis patients (PI-Ds) and subjects without chronic kidney disease (the controls), as well as their humoral response to the third dose of the same mRNA vaccine (second protocol). The respective reduction in antibody titer after 3 and 6 months by 82.9% and 93.03% in IN-Ds (n = 109), 73.4% and 93.36% in PI-Ds (n = 32) and 75.5% and 88.8% in the controls (n = 20) was demonstrated. Consequently, a protective antibody titer above 141 BAU/mL was found in only 47.7% and 23.8% of IN-Ds after 3 and 6 months, respectively. After the third vaccine dose, a significant increase in antibody titer was observed in all groups, with increases by a factor of ×51.6 in IN-Ds, ×30.1 in the controls and ×8.4 in PI-Ds. The median antibody titer after the third dose differed significantly between groups, and was the highest in PI-Ds: PI-Ds, 9090 (3300−15,000) BAU/mL; the controls, 6945 (2130−11,800); IN-Ds, 3715 (1470−7325) (p < 0.001). In conclusion, we observed similar degrees of antibody waning in all patients. After 3 months, over half of the infection-naïve dialysis patients had a very low antibody titer, and almost twenty percent of them had no antibodies at all. The humoral response to the third dose was very good, raising their titer of antibodies to a higher level than those in the general population who have received the primary two-dose scheme. The results support the administration of a complementary third dose of the mRNA vaccine for dialysis patients as soon as possible.

Humoral response to SARS-CoV-2 vaccination promises to improve the catastrophic prognosis of hemodialysis patients as a result of COVID-19: the COViNEPH Project.

Introduction: There is an urgent need to check the efficacy of SARS-CoV-2 vaccination among hemodialysis patients who are known to have large abnormalities of acquired immunity and a catastrophic risk of death from COVID-19. Objectives: In this cross-sectional study, we aimed to assess the humoral response following vaccination with the BNT162b2 (BioNTech / Pfizer Comirnaty) vaccine. Patients and methods: We analyzed the titer magnitude of the IgG antibodies directed against SARS-CoV-2 spike antigen 14 to 21 days after the second dose of the BNT162b2 vaccine in a group of hemodialysis patients who have not been confirmed with SARS-CoV-2 infection yet, compared with HD patients with a history of COVID-19. A total of 126 hemodialysis patients were stratified based on evidence of a previous infection with SARS-CoV-2 confirmed by the detection of viral RNA or nucleocapsid-specific IgG antibodies. Results: S-antigen immune response with a median (interquartile range) antibody titer of 366 (193­691) AU/ml was seen in 87 of 91 infection-naïve hemodialysis patients (95.6%), and in 68 (74.7%), a strong humoral response was observed with an anti-S antibodies titer greater than 200 AU/ml. Older patients were less likely to develop a response to S-antibodies (P <⁠0.001). The median (interquartile range) S-antigen antibody titer in 35 previously infected hemodialysis patients was over 12-fold higher than in infection-naïve hemodialysis patients: 4620 (1240­7820) AU/ml (P <⁠0.001). There were no significant differences in S-antibody titer between symptomatic and asymptomatic previously infected hemodialysis patients. Conclusions: Our study demonstrated that the majority of hemodialysis patients achieved a high immunization rate after vaccination with BNT162b2. Whether this translates into protecting this population from COVID-19 requires further research.

Safety and Tolerability of the BNT162b2 mRNA COVID-19 Vaccine in Dialyzed Patients. COViNEPH Project.

Background and Objectives: The Pfizer-BioNTech (BNT162b2) COVID-19 mRNA vaccine has demonstrated excellent efficacy and safety in phase 3 trials. However, no dialyzed patients were included, and therefore safety data for this patient group is lacking. The aim of the study was to assess the safety and tolerances of vaccinations with BNT162b2 performed in chronically dialyzed patients. Materials and Methods: We performed a prospective cohort study including a group of 190 dialyzed patients (65% male) at median age 68.0 (55-74) years. 169 (89.0%) patients were treated with hemodialysis and 21 (11.0%) with peritoneal dialysis. The control group consisted of 160 people (61% male) without chronic kidney disease at median age 63 (range 53-77) years. Both groups were vaccinated with BNT162b2 with a 21-day interval between the first and the second dose. Solicited local and systemic reactogenicity, unsolicited adverse events and antipyretic and pain medication use were assessed with a standardized questionnaire. The toxicity grading scales were derived from the FDA Center for Biologics Evaluation and Research guidelines. Results: 59.8% (dose 1), 61.4% (dose 2) and 15.9% (dose 1), 29.4% (dose 2) dialyzed patients reported at least one local and one systemic reaction respectively within seven days after the vaccination. Many local and systemic solicited reactions were observed less frequently in dialyzed patients than in the age and sex matched control group and much less frequently than reported in the pivotal study. They were mostly mild to moderate, short-lived, and more frequently reported in younger individuals and women. No related unsolicited adverse events were observed. Conclusions: We have shown here that BNT162b2, an mRNA vaccine from Pfizer-BioNTech against SARS-COV-2 is safe and well-tolerated by dialyzed patients. The results can be useful for the nephrological community to resolve patients' doubts and reduce their vaccine hesitancy.

[Genetic predisposition to systemic complications of arterial hypertension in maintenance haemodialysis patients]. / Potencjalne predyspozycje genetyczne do powiklan nadcisnienia tetniczego u chorych leczonych powtarzanymi hemodializami.

UNLABELLED: Cardiovascular disease is the most common cause of a high morbidity and mortality in patients on renal replacement therapy and is responsible for about 50% of deaths. Hypertension is the main risk factor for cardiovascular events in the general population as well as in haemodialysed (HD) patients. The hypertension in HD patients is caused by excess extracellular fluid volume (ECV) on the other hand hypertension resistant to normalization of ECV may result from the accelerated activity of the systemic and local--vascular renin-angiotensin-aldosteron system (RAAS). RAAS genes are potential etiological candidates for cardiovascular damage. The aim of the study was to evaluate the prevalence of hypertension, left ventricular hypertrophy, hypertensive retinopathy in patients treated with haemodialysis and to evaluate the association between the polymorphism of RAAS genes: ACE I/D, AGT M235T AT1R A1166C, CYP112 (-344) and the systemic complications of arterial hypertension such as hypertensive retinopathy, left ventricular hypertrophy and also mortality in haemodialysis patients. MATERIAL AND METHODS: The studied population consisted of 302 HD patients (175 men, 127 women) age 21-87, mean 56, at four dialysis units. Patients with cardiac defect, advanced coronary artery disease and atrial fibrillation were excluded from the study. 62 patients died during 3,5 years of observation. Methods consisted of tree times repeated blood pressure measurements before and post dialysis, echocardiography, direct opthalmoscopy (Keith-Wegener-Barker classification of hypertensive retinopathy) and DNA analysis--genotypes ACE I/D, AGT M235T AT1R A1166C, CYP11B2 T(-344)C were determined through PCR or PCR-RFLP method. RESULTS: Hypertension was present in 72%, LVH in 84% haemodialysed patients. Arterial pressure correlated with LVMI values and hypertension was connected with LVH. Insufficient control of blood pressure and LVH were connected with worse survival in HD patients. CONCLUSIONS: It seems that I/D polymorphism ACE gene and AC AT1 gene influence the development of hypertension and LVH in HD patients. The most dangerous in the development of hypertension and LVH was DD genotype ACE gene and CC AT1 gene. ACE I/D, AGT M/T, AT1 A/C, CYP11B2 T/C polymorphism appears to have no relation to the short-term prognosis in HD patients. The mortality did not differ among groups with different genotypes of ACE I/D, AGT M/T AT1 A/C, CYP11B2 T/C polymorphisms. Direct ophtalmoscopy seems to be an insufficient method in the estimation of the systemic complications of hypertension in haemodialysed patients.