scholarly journals Antibody Response and Safety After mRNA-1273 SARS-CoV-2 Vaccination in Peritoneal Dialysis Patients – the Vienna Cohort

2021 ◽  
Vol 12 ◽  
Author(s):  
Georg Beilhack ◽  
Rossella Monteforte ◽  
Florian Frommlet ◽  
Martina Gaggl ◽  
Robert Strassl ◽  
...  

BackgroundDialysis patients are at high risk for a severe clinical course after infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Safety and early immune responses after mRNA-based vaccination have been reported mostly in patients on hemodialysis (HD), whereas reports of peritoneal dialysis (PD) patients remain rare.MethodsIn this retrospective observational study, 39 PD patients had received two doses of the mRNA-1273 Moderna® vaccine. We analyzed SARS-CoV-2 Spike (S) antibody titers 4 weeks after each dose of mRNA-1273 and report local and systemic side effects in PD patients that occurred within one week after each mRNA-1273 dose. Using a quantile regression model we examined factors that might influence SARS-CoV-2 S antibody levels in PD patients.ResultsFour weeks after the first dose of mRNA-1273 vaccine 33 of 39 (84.6%) PD patients seroconverted and presented with 6.62 U/mL (median; IQR 1.57-22.5) anti-SARS-CoV-2 S antibody titers. After the second dose, 38 of 39 (97.4%) PD patients developed anti-SARS-CoV-2 S antibodies and titers increased significantly (median 968 U/mL; IQR 422.5-2500). Pain at the injection site was the most common local adverse event (AE) (71%). Systemic AEs occurring after the first dose were mostly fatigue (33%) and headache (20%). No severe systemic AEs were reported after the first injection. After the second dose the incidence and the severity of the systemic AEs increased. The most common systemic AEs were: fatigue (40.5%), headache (22.5%), joint pain (20%), myalgia (17.5%) and fever (13%). Lower Davies Comorbidity Score (p=0.04) and shorter dialysis vintage (p=0.017) were associated with higher antibody titers after the first dose. Patients with higher antibody titers after the first dose tended to have higher antibody titers after the second dose (p=1.53x10-05).ConclusionsPeritoneal dialysis patients in this cohort had a high seroconversion rate of 97.4%, showed high antibody titers after full vaccination and tolerated the anti-SARS-CoV-2 mRNA-1273 vaccine well without serious adverse events.

2021 ◽  
Vol 11 (1) ◽  
pp. 64
Author(s):  
Noa Berar-Yanay ◽  
Sarit Freiman ◽  
Maʹanit Shapira ◽  
Amer Saffoury ◽  
Ameer Elemy ◽  
...  

Background and objectives: The short-term reported antibody response to SARS-COV-2 vaccination in dialysis patients is high, with a seroconversion response rate up to 97%. Data on the long-term durability of this response are scarce. Our objective was to characterize the long-term anti-spike antibody level in dialysis patients. Design, setting, participants, and measurements: In an observational study, we measured SARS-COV-2 anti-spike antibody levels in dialysis patients who completed 2 doses of the BNT162b2 mRNA SAR S-COV-2 vaccine at 1, 3 and 6 months after the second vaccine dose. We compared the response to dialysis patients who were infected with COVD-19 and to a control group of healthcare-employees. Results: One hundred and forty-two dialysis patients who had been vaccinated (ages 64 ± 11.9 years, 61% male), 33 dialysis patients who had COVID-19 infection (ages 54 ± 14.3 years, 55% male) and 104 individuals in the control group (ages 50 ± 12.2 years, 44% male) were included. The response rate in the vaccinated dialysis patients was 94%, 78% and 73% at 1, 3 and 6 months after the second vaccine dose. In the COVID-19 infected dialysis group and in the control group, the response rate remained at 100% over 6 months. The percentage of change in antibody levels between one and 6 months was −66% in the vaccinated dialysis group, −28% in the control group (p < 0.001) and +48% in dialysis patients who had been infected with COVID-19 (p < 0.001). A non-responder status at 6 months was associated with a lower albumin level. No serious adverse events following vaccination were reported. In conclusion: the initially high response rate to the BNT162b2 vaccine in dialysis patients decreases rapidly. Our results indicate that an early booster (3rd) dose, at three months after the second dose, may be advised for this population to preserve the humoral immunity.


2015 ◽  
Vol 35 (1) ◽  
pp. 78-84 ◽  
Author(s):  
Annie-Claire Nadeau-Fredette ◽  
Joanne M Bargman

IntroductionPeritonitis remains a common complication of peritoneal dialysis (PD). Although representing only 1 – 12% of overall peritonitis in dialysis patients, fungal peritonitis (FP) is associated with serious complications, including technique failure and death. Only scarce data have been published regarding FP outcomes in modern cohorts in North America. In this study we evaluated the rates, characteristics and outcomes of FP in a major North American PD center.MethodsWe conducted a retrospective cohort study including all fungal peritonitis episodes among peritoneal dialysis patients followed in a large PD center between January 2000 and February 2013. Our pre-specified end-points included rates of FP, characteristics, outcomes and determinants of death.ResultsThirty-six episodes of FP were identified during the follow-up period (one episode per 671 patient-months), representing 4.5% of the total peritonitis events. Patients’ mean age and peritoneal dialysis vintage were 61.3 ± 15.5 and 2.9 (1.5 – 4.8) years, respectively. Of the 36 episodes of FP, seven (19%) resulted in death and 17 (47%) led to technique failure with permanent transfer to hemodialysis. Surprisingly, PD was eventually resumed in 33% of cases with a median delay of 15 weeks (interquartile range 8 – 23) between FP and catheter reinsertion. In a univariable analysis, a higher Charlson comorbidity index (Odds ratio [OR] 3.25 per unit increase, 95% confidence interval [CI] 1.23 – 8.58) and PD fluid white blood cell (WBC) count greater than 3,000/mm3at presentation (OR 6.56, 95% CI 1.05 – 40.95) predicted death.ConclusionWhile fungal peritonitis is still associated with a high frequency of death and technique failure, one-third of our patients eventually returned to PD. Patients with a high burden of comorbidities appear at higher risk of death. We postulate that the high mortality associated with FP is partially related to the severity of comorbidity among patients with F P, rather than the infection per se. Importantly, PD can be resumed in a significant proportion of cases.


1996 ◽  
Vol 16 (4) ◽  
pp. 370-373 ◽  
Author(s):  
Abdul N. Khan ◽  
Judy Bernardini ◽  
Raymond M. Rault ◽  
Beth Piraino

Objective To compare seroconversion using hepatitis B vaccine between hemodialysis (HD) and peritoneal dialysis (PD) patients. Design Data on PD patients vaccinated were collected retrospectively for the period 1992 to 1995. The data on HD patients were collected prospectively from 1991 to 1994. Setting A university outpatient dialysis center. Participants All adult patients who received all four doses of hepatitis B vaccine while on dialysis were included (47 PD and 50 HD patients). Intervention Recombinant hepatitis B vaccine (Engerix), 40 μg IM was administered at 0, 1, 2, and 6 months. Main Outcome Measure Seroconversion was measured after completion of the vaccination series. Results 74% of the HD patients seroconverted compared to 53 % of PD patients (p = 0.03). Older, heavier patients compared to all the other patients had a lower seroconversion rate in both the HD patients (55 % vs. 78 %) and PD patients (38 % vs. 59 %) (p = 0.03). Conclusion The seroconversion rate to recombinant hepatitis B vaccine is lower in patients on PD than on HD for unclear reasons. Further studies are required to determine the etiology of this difference.


2008 ◽  
Vol 28 (4) ◽  
pp. 397-402 ◽  
Author(s):  
Li-Tao Cheng ◽  
Yan-Li Gao ◽  
Chao Qin ◽  
Jun-Ping Tian ◽  
Yue Gu ◽  
...  

Objective In dialysis patients, volume overhydration is common and is related to increased risk of cardiovascular morbidity and mortality. However, it remains unclear whether volume overload imposes those detrimental effects through endothelial dysfunction. Methods In this cross-sectional study, 81 stable patients on continuous ambulatory peritoneal dialysis in a single center were recruited. Volume status was evaluated by extracellular water, assessed by bioimpedance analysis, and normalized to individual height (nECW). Endothelial function was estimated by endothelial-dependent flow-mediated dilatation (FMD) of the brachial artery and expressed as percentage change relative to baseline diameter. Results There were 37 male and 44 female patients (mean age 61 ± 12 years, dialysis vintage 20 ± 23 months). FMD in female patients was significantly higher than that in male patients (9.17% ± 6.23% vs 6.31% ± 5.01%, p < 0.05). FMD was negatively correlated with weight ( r = -0.308, p < 0.01), body mass index ( r = -0.242, p < 0.05), systolic blood pressure ( r = -0.228, p < 0.05), ECW ( r = -0.404, p < 0.001), and nECW ( r = -0.418, p < 0.001). No correlation was found between FMD and other variables. In multiple stepwise regression analysis, calcium x phosphate product (² = 0.422, p < 0.001), nECW (² = -0.343, p < 0.01), and dialysis vintage (² = -0.237, p < 0.05) were independent determinants of FMD (adjusted R2 = 0.327 for this model). Conclusion There was independent correlation between index of volume status and FMD, and higher nECW was related to worse endothelial function. The results of this study may help us understand the underlying mechanism of volume overhydration leading to increased cardiovascular morbidity and mortality in dialysis patients.


2015 ◽  
Vol 35 (2) ◽  
pp. 206-215 ◽  
Author(s):  
Hong Xu ◽  
Makoto Watanabe ◽  
Abdul Rashid Qureshi ◽  
Olof Heimbürger ◽  
Peter Bárány ◽  
...  

Background and Aims Increased oxidative stress in dialysis patients is thought to contribute to increased mortality; however, confirmatory data are scarce. We analyzed the serum concentration of 8-hydroxy-2'–deoxyguanosine (8-OHdG), a marker of oxidative stress, in relation to mortality in hemodialysis (HD) and peritoneal dialysis (PD) patients. Methods Serum 8-OHdG, interleukin 6 (IL-6), other biochemical markers, Davies comorbidity score, and protein-energy wasting (PEW) were assessed in 303 prevalent patients treated with HD (n = 220; age: 63 ± 14 years) or PD (n = 83; age: 64 ± 14 years). Mortality was assessed after a median follow-up of 31 months. Results The median (25th - 75th percentile) concentration of 8-OHdG was higher in HD than in PD patients: 1.3 ng/mL (0.9 - 1.8 ng/mL) versus 0.5 ng/mL (0.4 - 0.6 ng/mL), p < 0.001. The HD modality (standard β = 0.57, p < 0.001) and dialysis vintage (standard β3 = 0.12, p = 0.02) were independent predictors of serum 8-OHdG in a multivariable linear regression model including age, sex, body mass index, dialysis modality (HD or PD), preceding time on dialysis (dialysis vintage), PEW, comorbidity score, IL-6, and use of angiotensin converting-enzyme inhibitors or angiotensin II receptor blockers or statins. During follow-up, 107 patients died. In multivariable Cox regression models including all 303 patients and adjusted for age, sex, body mass index, dialysis modality, dialysis vintage, and comorbidity score, 8-OHdG was significantly associated with all-cause mortality (adjusted hazard ratio: 1.40; 95% confidence limits: 1.05, 1.87 for 1 standard deviation increase of 8-OHdG). In subgroup analyses according to dialysis modality, 8-OHdG was associated with mortality in HD patients but not in PD patients. Conclusions Oxidative stress as assessed by 8-OHdG is an independent predictor of all-cause mortality in dialysis patients. This association was seen in HD patients, but no such association could be demonstrated for PD patients.


2021 ◽  
pp. 041-048
Author(s):  
Ameri Mahmoud ◽  
Lewis Hayley ◽  
Nguyen Joe

The purpose of the study was to evaluate the immunogenicity and safety of an inactivated influenza split virion vaccine administered via a transdermal microneedle system. In this Phase 1, single-center, randomized, controlled study, 90 subjects aged 18 to 40 years received influenza vaccine (strains (A/H1N1, A/H3N2, and B) either via a transdermal microneedle system (“patch”; 10 µg) for 5 or 15 minutes or by Intramuscular (IM) injection (15g). Influenza antibody titers were measured by the hemagglutinin inhibition method and compared to EMEA guidelines for influenza vaccines (seroconversion rate, mean increase in hemagglutinin inhibition titer, and percentage of seroprotected subjects). Safety was assessed through local and systemic adverse events, and specific application site events in the transdermal groups. At Day 21, the EMEA criteria were met in all treatment groups for all three influenza strains. The immunogenicity response was similar between all three groups and increased antibody levels persisted to Month 6. The transdermal microneedle system was generally well tolerated, although pinpoint red spots, edema, and erythema were noted after patch removal in most subjects. Influenza vaccination administered via a novel transdermal microneedle system was generally well tolerated and provided similar antibody response using a lower dose than IM injection.


2012 ◽  
Vol 32 (3) ◽  
pp. 348-351 ◽  
Author(s):  
Edyta Zbroch ◽  
Jolanta Malyszko ◽  
Jacek Malyszko ◽  
Ewa Koc–Zorawska ◽  
Michal Mysliwiec

Author(s):  
Paul Lesny ◽  
Mark Anderson ◽  
Gavin Cloherty ◽  
Michael Stec ◽  
Anja Haase-Fielitz ◽  
...  

Abstract Background Dialysis patients are at risk for lower SARS-CoV-2-vaccine immunogenicity than the normal population. We assessed immunogenicity to a first mRNA- or vector-based SARS-CoV-2-vaccination dose in dialysis patients. Methods In a multicenter observational pilot study, 2 weeks after a first vaccination (BNT162b2/Pfizer-BioNTech [Comirnaty] or ChAdOx1 nCoV-19/Oxford-Astra-Zeneca [Vaxzevria]), hemodialysis patients (N = 23), peritoneal dialysis patients (N = 4) and healthy staff (N = 14) were tested for SARS-CoV-2-spike IgG/IgM, Nucleocapsid-protein-IgG-antibodies and plasma ACE2-receptor-binding-inhibition capacity. Hemodialysis patients who had had prior COVID-19 infection (N = 18) served as controls. Both response to first SARS-CoV-2 vaccination and IgG spike-positivity following prior COVID-19 infection were defined as SARS-CoV-2 spike IgG levels ≥ 50 AU/mL. Results Vaccination responder rates were 17.4% (4/23) in hemodialysis patients, 100% (4/4) in peritoneal dialysis patients and 57.1% (8/14) in staff (HD vs. PD: p = 0.004, HD vs. staff: p = 0.027). Among hemodialysis patients, type of vaccine (Comirnaty N = 11, Vaxzevria N = 12, 2 responders each) did not appear to influence antibody levels (IgG spike: Comirnaty median 0.0 [1.–3. quartile 0.0–3.8] versus Vaxzevria 4.3 [1.6–20.1] AU/mL, p = 0.079). Of responders to the first dose of SARS-CoV-2 vaccination among hemodialysis patients (N = 4/23), median IgG spike levels and ACE2-receptor-binding-inhibition capacity were lower than that of IgG spike-positive hemodialysis patients with prior COVID-19 infection (13/18, 72.2%): IgG spike: median 222.0, 1.–3. quartile 104.1–721.9 versus median 3794.6, 1.–3. quartile 793.4–9357.9 AU/mL, p = 0.015; ACE2-receptor-binding-inhibition capacity: median 11.5%, 1.–3. quartile 5.0–27.3 versus median 74.8%, 1.–3. quartile 44.9–98.1, p = 0.002. Conclusions Two weeks after their first mRNA- or vector-based SARS-CoV-2 vaccination, hemodialysis patients demonstrated lower antibody-related response than peritoneal dialysis patients and healthy staff or unvaccinated hemodialysis patients following prior COVID-19 infection. Graphic abstract


2020 ◽  
Vol 7 ◽  
pp. 205435812091265 ◽  
Author(s):  
Judith G. Marin ◽  
Laura Beresford ◽  
Clifford Lo ◽  
Alexander Pai ◽  
Gabriela Espino-Hernandez ◽  
...  

Background: Patients treated with maintenance dialysis are at high risk of polypharmacy given their many comorbidities as well as complications from their disease state and treatment. The prescribing patterns and burden of polypharmacy in patients treated with maintenance dialysis, and specifically the difference between hemodialysis (HD) and peritoneal dialysis (PD) prescribing, are not well characterized. Objectives: The objectives of this study were to review the prescribing patterns for patients treated with maintenance dialysis, to compare prescribing pattern between HD and PD, and to identify opportunities for deprescription. Design: This is a retrospective cohort study. Setting: This study was conducted in all dialysis centers in British Columbia, Canada. Patients: Patients who were receiving chronic dialysis (>120 days on the same dialysis modality) between June 3 and October 1, 2015, and registered in the British Columbia (BC) Renal Patient Records and Outcomes Management Information System. Measurements: Patient demographics as well as both prescription and non-prescription medications were collected. Comparison of discrete and continuous variables was made by chi-square analysis and independent t test, respectively. All statistical tests were 2-sided, and a P value of <.05 was considered statistically significant. Methods: Medications were classified by indication: (1) management of renal complications, (2) cardiovascular (CV) medications, (3) diabetes medications, or (4) management of symptoms, and then classified as to whether they were a “potentially inappropriate medication” (PIM) or not. Ethics approval was granted from the University of British Columbia Research and Ethics Board. Results: In total, 3017 patients met inclusion criteria (2243 HD, 774 PD). The mean age was 66.2 ± 14.8 years. The HD group had more patients over 80 years old (22.1% vs 12.5%) and more patients with diabetes and CV disease. The mean number (standard deviation [SD]) of discrete prescribed medications was 17.71 (5.72) overall with more medications in the HD group versus the PD group. The mean number of medications increased with dialysis vintage in both groups. HD patients were on more medications for renal complications and management of symptoms than PD patients. Of the total number of medications prescribed, 5.02 (2.78) were classified as a PIM, with the number of PIMs higher in HD vs PD patients: 5.37 (2.83) versus 4.02 (2.37). Limitations: In BC, some of the medications are prescribed through standardized protocols and may not be comparable with other Canadian provinces. We report here prescribing patterns, not utilization patterns, as we are not able to ascertain actual consumption of prescribed medication. Conclusion: This study reviews and characterizes both the prescription and non-prescription medication prescribed to HD patients and PD patients in BC. Pill burden in both groups is high, as is the prescription of PIMs. Patients receiving maintenance HD receive more overall medications and more PIMs. These results highlight areas of opportunities for future systematic and patient-informed deprescription initiatives in both patient groups.


2022 ◽  
Author(s):  
Urska Janzic ◽  
Urska Bidovec-Stojkovic ◽  
Katja Mohorcic ◽  
Loredana Mrak ◽  
Nina Fokter Dovnik ◽  
...  

Abstract Background: SARS-CoV-2 vaccination in cancer patients is crucial since they are at increased risk of severe COVID-19 disease course, but data on efficacy and safety of vaccination are scarce.Methods: We performed a prospective observational study of patients with solid cancers on active anticancer treatment (chemotherapy, immunotherapy with immune checkpoint inhibitors (ICI) or targeted therapy) that received mRNA-based SARS-CoV-2 vaccination at two institutions in Slovenia. The immunogenicity was assessed by the detection of anti-SARS-CoV-2 S1 IgG antibodies in serum; patients were sampled before, 2-3 weeks after the first dose, 2-3 weeks after the second dose, and 3 months after the complete primary course of vaccination. The results were also compared to controls, sampled at similar time points.Results: Between March and July 2021 112 patients were included in the analysis. The seroconversion rate in patients without prior COVID-19 infection was 96% after the complete primary course of vaccination with 2 doses, compared to 100% for healthy controls. The seroconversion rate after vaccination for patients on chemotherapy, ICI, and targeted therapy was 100%, 91%, and 97%, respectively. All controls and the majority of patients on chemotherapy and targeted therapy, but only 83% for patients on ICI were adequate responders (anti-SARS-CoV-2 S1 IgG ≥ 880 ng/ml). Three months after the vaccination, a significant drop in antibody levels was observed in patients receiving ICI compared to controls (P < 0.001). Adverse events were mostly mild and predictable, none of the patients experienced serious adverse events after vaccination.Conclusions: Immunogenicity after mRNA-based vaccination against SARS-CoV-2 in cancer patients is only slightly impaired, but influenced by the type of anticancer therapy received. Patients on ICI have the slightest and gradual antibody production. Since antibody levels decline after three months, a third vaccination dose is reasonable to provide adequate protection against severe COVID-19 disease course.The study was approved by the National Ethics Committee (No. 0120-39/2021/6)


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