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

Medicina, Journal Year: 2021, Volume and Issue: 57(7), P. 732 - 732

Published: July 19, 2021

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

Language: Английский

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Effect of a Third Dose of SARS-CoV-2 mRNA BNT162b2 Vaccine on Humoral and Cellular Responses and Serum Anti-HLA Antibodies in Kidney Transplant Recipients

Vaccines, Journal Year: 2022, Volume and Issue: 10(6), P. 921 - 921

Published: June 9, 2022

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has severely impacted on public health, mainly immunosuppressed patients, including solid organ transplant recipients. Vaccination represents a valuable tool for the prevention of SARS-CoV-2 infection, and immunogenicity mRNA vaccines been evaluated in transplanted patients. In this study, we investigated role third dose BNT162b2 vaccine cohort kidney recipients, analyzing both humoral cell-mediated responses. We observed an increased immune response after vaccine, especially terms Spike-specific T cell response. level seroconversion remained lower than 50% even administration dose. Mycophenolate treatment, steroid age seemed to be associated with poor our cohort, 11/45 patients experienced infection HLA antibodies appearance was recorded 7 out 45 (15.5%) but none developed renal rejection. Further studies evaluation long-term responses are still ongoing, impact fourth will evaluated.

Language: Английский

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Persistent Post-COVID-19 Syndrome in Hemodialyzed Patients—A Longitudinal Cohort Study from the North of Poland

Journal of Clinical Medicine, Journal Year: 2021, Volume and Issue: 10(19), P. 4451 - 4451

Published: Sept. 28, 2021

After recovery from COVID-19, patients frequently face so-called "Post-COVID-19 Syndrome" defined by clusters of persistent symptoms lasting for >12 weeks which may arise any system in the body. The long-term health consequences COVID-19 maintenance hemodialyzed (HD) remain to be investigated.In this longitudinal cohort study we described HD requiring hospitalization due COVID-19. They were interviewed three and six months (M3 M6) after discharge with a series standardized questionnaires.Of 144 discharged 7th Naval Hospital Gdansk, 79 participants enrolled, 39 m (49.4%) 40 f (50.6%) median age 70.0 (64.0-76.5) an vintage (17.5-88). discharge, 93.7% 81% reported at least one symptom M3 M6, respectively. most common fatigue or muscle weakness (60.76% 47.04%) palpitations (40.51% 30.14%). Dyspnea mMRC scale grade 1 was 21.5% before infection, 43.03% 34.25% A decrease quality life all domains EQ-5D-5L questionnaire but mainly pain/discomfort anxiety dimensions. Mean EQ-VAS scores 69.05, 61.58 64.38, respectively.Our showed that still experience can further reduce their already poor health-related life. This highlights need follow-up on these diagnostic rehabilitation programs.

Language: Английский

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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

Polskie Archiwum Medycyny Wewnętrznej, Journal Year: 2021, Volume and Issue: unknown

Published: Aug. 5, 2021

ARTICLE Humoral response after vaccination in hemodialyzed patients 797 rates hemodialysis with COVID-19 a fatality rate up to 43.81% older than 74 years. 2 In such circumstances, is the only chance improve extremely poor prognosis that patient population.However, as of now, there are very limited data on patients. 3,4Furthermore, given fact have numerous and diverse disturbances INTRODUCTION Patients chronic been identified particularly susceptible SARS -CoV -2 infection due unavoidable exposure.This population also characterized by high comorbidities varying degrees immunosuppression, which puts them at risk severe forms COVID -19 ranging from 16% 32%. 1 our recent study, we showed mortality

Language: Английский

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Post-COVID-19 Sydrome and Decrease in Health-Related Quality of Life in Kidney Transplant Recipients after SARS-COV-2 Infection—A Cohort Longitudinal Study from the North of Poland

Journal of Clinical Medicine, Journal Year: 2021, Volume and Issue: 10(21), P. 5205 - 5205

Published: Nov. 8, 2021

Introduction: Patients after SARS-CoV-2 infection frequently face “Post-COVID-19 Syndrome”, defined by symptoms that develop during or COVID-19, continue for more than 12 weeks, and are not explained an alternative diagnosis. We aimed to evaluate the presence of post-COVID-19 syndrome its predictors in kidney transplant recipients (KTR) 6 months disease. Materials Methods: A total 67 KTR (38 m) with a mean age 53.6 ± 14 years, 7.3 6.4 years post-transplant were included cohort longitudinal study. Thirty-nine (58.2%) them hospitalized, but one required invasive ventilation therapy. They interviewed being infected, series standardized questionnaires: self-reported questionnaire, modified British Medical Research Council (mMRC) dyspnea scale, EQ-5D-5L EQ-VAS scale. Results: Post-COVID-19 was diagnosed 70.1% 26.9% reported at least three persistent symptoms. The most common fatigue (43.3%), hair loss (31.3%), memory impairment (11.9%), muscle aches, headaches (11.9%). Dyspnea mMRC scale grade 1 34.3% patients vs. 14.9% before infection; 47.8% stated they still feel worse Mean scores 64.83 73.34 infection. frequent older those greater comorbidity. Conclusions: Persistent present majority KTR, which highlights need long-term follow-up as well diagnostic rehabilitation programs.

Language: Английский

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Clinical manifestations of COVID-19 infection in dialysis patients and protective effect of COVID-19 vaccine

Inflammation Research, Journal Year: 2023, Volume and Issue: 72(5), P. 989 - 1000

Published: April 1, 2023

Language: Английский

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Predictors of Mortality in Hemodialyzed Patients after SARS-CoV-2 Infection

Journal of Clinical Medicine, Journal Year: 2022, Volume and Issue: 11(2), P. 285 - 285

Published: Jan. 6, 2022

Introduction: The determinants of COVID-19 mortality are well-characterized in the general population. Less numerous and inconsistent data among maintenance hemodialysis (HD) patients, who population most at risk an unfavorable prognosis. Methods: In this retrospective cohort study we included all adult HD patients from Pomeranian Voivodeship, Poland, with laboratory-confirmed SARS-CoV-2 infection hospitalized between 6 October 2020 28 February 2021, both those survived, also died. Demographic, clinical, treatment, laboratory on admission, were extracted electronic medical records dedicated hospital patients’ dialysis unit, compared survivors non-survivors. We used univariable multivariable logistic regression methods to explore factors associated 3-month all-cause mortality. Results: 133 (53.38% males) aged 73.0 (67–79) years, a median duration 42.0 (17–86) months, study. At diagnosis, majority considered have mild course (34 asymptomatic, another 63 subjects presented symptoms), while 36 (27.07%) had low blood oxygen saturation required supplementation. Three-month was 39.08% including in-hospital case fatality rate 33.08%. Multivariable showed that frailty clinical index 4 or greater (OR 8.36, 95%CI 1.81–38.6; p < 0.01), D-Dimer 1500 ng/mL (6.00, 1.94–18.53; CRP >118 mg/L admission (3.77 1.09–13.01; = 0.04) found be predictive Conclusion: Very high determined mainly by frailty. High D-dimer levels upon further confer risk.

Language: Английский

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

Vaccines, Journal Year: 2022, Volume and Issue: 10(3), P. 433 - 433

Published: March 11, 2022

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

Language: Английский

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COVID-19 vaccination reduces mortality in patients on maintenance hemodialysis

Frontiers in Medicine, Journal Year: 2022, Volume and Issue: 9

Published: Sept. 8, 2022

Patients with chronic kidney disease on maintenance hemodialysis (HD) have a very high risk of death in the course COVID-19. The aim study was to assess effectiveness COVID-19 vaccination reduce incidence and fatality rate HD patients. A retrospective registry-based cohort performed all adult patients Pomeranian Voivodeship. Vaccinations were carried out from January April 2021 mRNA vaccines, either BNT162b2 or mRNA-1273 two-dose schedule. In first analysis (2nd pandemic wave), 1,160 unvaccinated included (59.7% males, 25.7% diabetic). second (4th 1,131 (59.4% male, 30.7% diabetic) individuals included, 1,042 (92.13%) fully vaccinated. Three hundred fifteen (27.2%) positive during 2nd wave, 6.9% (78/1,131) 4th wave. Within vaccinated 60 positive, 5.8 vs. 20.2% respectively. ratio (IRR) 0.21 wave-vaccinated wave-unvaccinated) indicating 79% reduction. IRR between wave 0.28 favor 72% 93 died as result (fatality rate: 29.5%). 6.7% (p = 0.004), while within accounted for 11.1%. Significant clinical demonstrated multicenter

Language: Английский

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Humoral and cellular response to SARS-CoV-2 BNT162b2 mRNA vaccine in hemodialysis patients

BMC Immunology, Journal Year: 2021, Volume and Issue: 22(1)

Published: Oct. 19, 2021

Abstract Background Hemodialysis (HD) patients have an increased risk of acquiring infections due to many health care contacts and may, in addition, a suboptimal response vaccination high mortality from Covid-19 infection. Methods In 50 HD (mean age 69.4 years, 62% men) administration SARS-CoV-2BNT162b2 mRNA vaccine began Dec 2020 the immune was evaluated 7–15 weeks after last dose. Levels (SARS-CoV-2) IgG antibody against nucleocapsid antigen (anti-N) Spike (anti-S) T-cell reactivity testing protein using ELISPOT technology were evaluated. Results Out patients, anti-S antibodies indicating effect or previous infection, detected 37 (74%), 5 (10%) had borderline 8 (16%) negative two doses vaccine. responses 29 (58%). Of with antibodies, 25 (68%) measurable response. 2 (40%) out (25%) without concomitant Twenty-seven (54%) both anti-N disease 7 (14%) patients. Conclusions Most develop B- and/or but approx. 20% limited immunological only present few

Language: Английский

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