Vaccination In Dialysis Patients Research Articles

Investigating the effect of serum level of uric acid on the immunogenicity of hepatitis B vaccination in dialysis patients

IntroductionHBV infection is a significant concern in dialysis patients, influenced by various factors. This study aims to investigate the impact of serum uric acid levels on the immunogenicity of hepatitis Bvaccination in dialysis patients.MethodA cross-sectional study was conducted, involving 125 hemodialysis patients. Prior to dialysis, assessments were made for uric acid, vitamin D, HBsAg, andHBsAb. Patients were divided into two groups based on uric acid levels: high level (≥ 6.5 mg/dl) and low level (< 6.5 mg/dl). Each group received three doses of a high-dose hepatitis B vaccine (40 mcg) at 0, 1, and 6 months. After 8 weeks of the 3rd dose of the vaccine, the anti-hepatitis B antibody titer (HBsAb) was measured and recorded. Data were analyzed using SPSS version 22.ResultsAmong patients with high uric acid, 30 (26.8%) had low HBsAb and 82 (73.2%) had high HBsAb (> 10). In patients with low uric acid, 1 (7.7%) had low HBsAb and 12 (92.3%) had high HBsAb (> 10). There was no statistically significant difference inHBsAb between the two groups. The immune response of HBsAb and uric acid did not show significance based on demographic variables and laboratory results.ConclusionThis study found no correlation between uric acid levels and the immunogenicity of hepatitis B vaccination in hemodialysis patients. However, it is important to note that the group with low serum uric acid was very small compared to the other group and this may have influenced these results. Further studies with larger patient populations are needed to provide more conclusive evidence in this area.

Potent induction of humoral and cellular immunity after bivalent BA.4/5 mRNA vaccination in dialysis patients

Knowledge on immunogenicity of the bivalent Omicron BA.4/5 vaccine in dialysis patients and the effect of a previous infection is limited. Therefore, vaccine-induced humoral and cellular immunity was analyzed in dialysis patients and immunocompetent controls with and without prior infection. In an observational study, 33 dialysis patients and 58 controls matched for age, sex and prior infection status were recruited. Specific IgG, neutralizing antibody activity and cellular immunity towards the spike-antigen from parental SARS-CoV-2 and Omicron-subvariants BA.1, BA.2 and BA.4/5 were analyzed before and 13-18 days after vaccination. The bivalent vaccine led to a significant induction of IgG, neutralizing titers, and specific CD4+ and CD8+ T-cell levels. Neutralizing activity towards the parental strain was higher than towards the Omicron-subvariants, whereas specific T-cell levels towards parental spike and Omicron-subvariants did not differ indicating substantial cross-reactivity. Dialysis patients with prior infection had significantly higher spike-specific CD4+ T-cell levels with lower CTLA-4 expression compared to infection-naive patients. When compared to controls, no differences were observed between infection-naive individuals. Among convalescent individuals, CD4+ T-cell levels were higher in patients and neutralizing antibodies were higher in controls. Vaccination was overall well tolerated in both dialysis patients and controls with significantly less adverse events among patients. In conclusion, our study did not provide any evidence for impaired immunogenicity of the bivalent Omicron BA.4/5 vaccine in dialysis patients. Unlike in controls, previous infection of patients was even associated with higher levels of spike-specific CD4+ T cells, which may reflect prolonged encounter with antigen during infection.

B and T cell responses to the 3rd and 4th dose of the BNT162b2 vaccine in dialysis patients

ABSTRACT Patients on dialysis (PoD) are at high risk of severe morbidity and mortality from COVID-19. Characterizing long-term vaccine immune responses in these patients will help optimize vaccine schedule for PoD. This study aimed to determine whether long-term humoral and B and T cell-responses post 3rd and 4th dose of the BNT162b2 vaccine differed between PoD and controls. Non-infected PoD and controls vaccinated with BNT162b2 were recruited in Ziv Medical Center, Israel, between 2021 and 2022. Specimens were collected 1–2 months pre 3rd dose; 1–3 months post 3rd dose; 4–5 months post 3rd dose and 3–5 months post the 4th dose. Anti-SARS-CoV-2 spike (spike) specific antibodies, spike specific memory B cells, and spike specific CD154+ T cells as well as cytokines producing CD4+/CD8+ T cells were measured using standardized assays and compared between PoD and controls at each time point using Mann Whitney and Fisher’s exact tests. We recruited 22 PoD and 20 controls. Antibody levels in PoD were lower compared to controls pre 3rd dose but not post 3rd and 4th doses. Frequencies of spike specific memory B cell populations were similar between PoD and controls overall. Frequencies of spike specific T cells, including those producing IFNγ and TNFα, were not lower in PoD. B and T cell mediated immune response in PoD following a 3rd and a 4th dose of the BNT162b2 vaccine was not inferior to controls up to 5 months post vaccination. Our results suggest that standard BNT162b2 vaccination is suitable for this group.

Monitoring strategy of COVID-19 vaccination in dialysis patients based on a multiplex immunodot method: The CovidDial study.

COVID-19 vaccine was demonstrated to be effective in dialysis patients, but boosters are mandatory due to a rapid waning of anti-spike antibodies. A vaccination strategy based on immunologic response might be useful to maintain a favorable risk-benefit balance in this vulnerable population. CoviDial is an observational prospective study enrolling 121 dialysis patients to receive a 3-dose mRNA-1273 vaccine according to a uniform schedule. At baseline, months 1, 3, 6, 9, and 12, anti-spike antibodies against four epitopes (S1, S2, ECD-S1 + S2, RBD) were monitored with a multiplex immunodot enzymatic assay. Potential correlation between initial serologic response and subsequent COVID-19 infection was then assessed. Overall, 96.2% and 96.8% of patients had anti-RBD antibodies at 3 and 12 months, respectively. All antibodies titers significantly decreased at month 6 compared to month 3. Booster vaccine induced a robust serologic response at month 9, but with a waning 3 months later, particularly for anti-S2 (37.2±3.3 vs. 61.3±3.0, p< 0.0001) and anti-S1 + S2 antibodies (68.4±3.3 vs. 88.4±2.3, p= 0.0015). Fifteen patients were later tested positive for SARS-CoV-2. At month 3, mean titers of anti-RBD, anti-S1 + S2, and anti-S2 antibodies were lower in the subsequent SARS-CoV-2 infected cohort (71.57 ±9.01 vs. 85.79 ±2.61, p= 0.0131; 41.07 ±7.96 vs. 61.68 ±3.56, p= 0.0237; 13.79 ±5.03 vs. 39.70 ±3.86, p= 0.0096; respectively). Three doses of mRNA-1273 vaccine induce a robust but time-limited immunologic response in dialysis patients. Lower anti-spike antibodies titers after initial vaccination are associated with a higher risk to subsequently contract SARS-CoV-2, even beyond 6 months.

Senescent Lymphocyte Subsets Exhibit an Unexpected Advantageous Effect in the Response Against SARS-CoV-2 Vaccination in Dialysis Patients

Senescent Lymphocyte Subsets Exhibit an Unexpected Advantageous Effect in the Response Against SARS-CoV-2 Vaccination in Dialysis Patients

Humoral response to SARS-CoV-2 vaccination in haemodialysis patients and a matched cohort

ObjectivesSARS-CoV-2 vaccination is a crucial intervention for infection control; however, the immune response to vaccination in dialysis patients has been reported to be moderate compared with healthy adults. There are...

Efficacy of COVID-19 Vaccination in Dialysis Patients: A Prospective Multicenter Study

Efficacy of COVID-19 Vaccination in Dialysis Patients: A Prospective Multicenter Study

Two Cases of Autoimmune Thyroid Disorders after COVID Vaccination in Dialysis Patients

SARS-CoV-2 infection and vaccination have been associated with autoimmune thyroid dysfunctions. Autoimmune/inflammatory syndrome induced by adjuvants (ASIA) and molecular mimicry have been referred to as potential causes. Such a case has not been reported in immunocompromised end-stage renal disease (ESRD) patients. Herein we present two dialysis patients with no previous history of thyroid disease who developed immune mediated thyroid disorders after BNT162b mRNA vaccine against SARS-CoV-2. The first patient is a 29-year-old man on hemodialysis diagnosed with Grave’s disease four months post-vaccination and the second one is a 67-year-old female on peritoneal dialysis who developed Hashimoto’s thyroiditis two months post-vaccination. Grave’s disease is uncommon in dialysis patients, whereas Hashimoto’s thyroiditis has a higher incidence in this population. Time proximity in both cases suggests potential causality. To our knowledge, this is the first report of de novo immune-mediated thyroid disorders in dialysis patients following vaccination against SARS-CoV-2.

Assessment of the humoral response to the homologous Gam-COVID-Vac (Sputnik V) or heterologous Sputnik V/mRNA-1273 (Moderna) vaccination against SARS-CoV-2 in dialysis patients.

Background and AimDialysis patients are a high-risk population and have a reduced immune response to vaccination against SARS-CoV-2. The aim of this study was to assess the humoral response to homologous Gam-COVID-Vac (Sputnik V) and heterologous Sputnik V/mRNA-1273 (Moderna) vaccination in dialysis patients. The vaccination scheme depended on dose availability and the prioritization of risk populations as established by the Argentine Ministry of Health.Methods Previous COVID-19 infection was determined in symptomatic patients. Binding IgG antibodies against the spike (S) receptor-binding domain (RBD) of SARS-CoV-2 (anti-S-RBD) concentration was assessed between 3 and 16 weeks after the boost dose. Anti-S-RBD antibodies were quantified using the Abbott Diagnostics SARS-CoV-2 IgG II Quant chemiluminescent microparticle immunoassay (CMIA) on an Architect i2000 SR and an Alinity I analyzer (Abbott Diagnostics, Abbott Park, Illinois, USA). To standardize the results to WHO binding antibody units (BAU), a correction factor for Abbott arbitrary units (AU) was applied where 1 BAU/mL equals 0.142 AU, as previously established by Abbott with the WHO international standard NIBSC 20–136. Following the manufacturer’s recommendations, samples were considered reactive for anti-S-RBD when titers were above 50 AU/mL (7.2 BAU/mL). An 80% protective effect (PROT-80) against symptomatic SARS-CoV-2 infection was assumed when anti-S-RBD titers were 506 BAU/ml or higher. Charlson Comorbidity Index (CCI) score was classified as mild = 1–2, moderate = 3–4, and severe ≥ 5. Side effects were evaluated until day 7 by patients´ self-reported questionnaire.ResultsOne hundred seven participants were enrolled [n = 84 homologous (SpV/SpV), nn 23 heterologous (SpV/Mod)]. Median (IQR) age was 64 (50–75) years old and 79 (73.8%) were male. Additionally, 19 (22.6%) of the SpV/SpV and 4 (17.4%) of the SpV/Mod group had a prior confirmed SARS-CoV-2 infection (p = 0.589). In the overall population, 103 patients reached seroconversion (96.3%). Anti-S-RBD IgG median titers (IQR) were higher in the heterologous [1222 (288–5680) BAU/mL] than in the homologous scheme [447 (100–1551) BAU/mL], p = 0.022. In a linear model adjusted for age, gender, days from first vaccination to boost dose and days from the boost dose to the anti-S-RBD IgG determination, previous SARS-COV-2 infection (B: 2062.2; CI95: 1231.8–2892.6; p < 0.001), and SpV/Mod vaccination scheme (B: 1294.6; CI95: 435.58–2147.6; p = 0.003) were independently associated with anti-S-RBD levels. Finally, a higher frequency of adverse effects was associated with the heterologous scheme, although they were well tolerated by all individuals.ConclusionsThe present study provides evidence that the homologous SpV/SpV and heterologous SpV/Mod schemes showed good efficacy and safety in patients on chronic dialysis. These results could be useful for designing future vaccination strategies, especially aimed at this risk group.Graphical abstract

Antibody Response and Adverse Events of AZD1222 COVID-19 Vaccination in Patients Undergoing Dialysis: A Prospective Cohort Study.

This study observed the antibody response and adverse events of AZD1222 (Oxford/AstraZeneca) vaccination in dialysis patients. A prospective cohort study was conducted in E-Da Healthcare Group hospitals between 1 July and 30 November 2021. Patients receiving hemodialysis (HD, n = 204) or peritoneal dialysis (PD, n = 116) were enrolled alongside healthy subjects (control, n = 34). Anti-SARS-CoV-2 S1 RBD IgG antibodies were measured before the first vaccination (T0), four to six weeks afterwards (T1), one week before the second dose (T2), and four to six weeks afterwards (T3). Adverse events were recorded one week after each dose. The positive IgG rates in the HD (T1: 72%; T2: 62%) and PD (T1: 69%; T2: 70%) groups were lower than the control group (T1: 97%; T2: 91%), with lower median antibody titers. At T3, the positive antibody response rates (HD: 94%; PD: 93%; control: 100%) and titers were similar. Titers were higher after the second dose in all groups. Adverse events were more severe after the first dose and less common with HD than PD or controls. Dialysis patients exhibited lower antibody responses than controls after the first dose of the AZD1222 vaccine but achieved similar responses after consecutive vaccination. Age, health status, two vaccine doses, and alcohol consumption may influence antibody levels.

COVID-19 beliefs and vaccination uptake in dialysis patients: lessons from an anonymous patient survey.

There is a lack of data on how to best optimise uptake of COVID-19 vaccination in dialysis patients. To understand attitudes and beliefs about COVID-19 and vaccination uptake in dialysis patients. A single-centre, cross-sectional study involving a clinical audit and an anonymous survey of adult maintenance dialysis patients was conducted. The vaccination uptake during the study period was 77.5% at least single dose, compared with 70% in Victoria during the same period. Participants were more likely to be vaccinated if they believed COVID-19 was a serious problem that is worse for people on dialysis. Those unvaccinated were more likely to overestimate the risk of vaccine complications and less likely to have the annual influenza vaccine. Despite over 80% of participants agreeing that they would have the vaccine if recommended by their nephrologist, less than 40% reported receiving information from this source. A predominant reason for vaccine hesitancy was concern regarding vaccine safety. Over 60% of those who were unvaccinated were still open to the vaccine, indicating a significant opportunity to improve vaccination rates through medical consultation and direction. Vaccine hesitancy for COVID-19 in dialysis patients associates with less informed health beliefs, both about the disease and the risks of vaccination. Patients are more likely to get vaccinated if it is recommended by their nephrologist. Clinicians caring for dialysis patients have a key role in providing high-quality education and advice, representing an urgent opportunity for improvement in vaccination uptake against COVID-19.

Efficacy of SARS-CoV-2 Vaccination in Dialysis Patients: Epidemiological Analysis and Evaluation of the Clinical Progress.

This study investigated the impact of the fourth COVID-19 pandemic wave on dialysis patients of Romagna territory, assessing the associations of vaccination status with infection risk, clinical severity and mortality. From November 2021 to February 2022, an epidemiological search was conducted on 829 patients under dialysis treatment for at least one month. The data were then analyzed with reference to the general population of the same area. A temporal comparison was also carried out with the previous pandemic waves (from March 2020 to October 2021). The epidemiological evolution over time in the dialysis population and in Romagna citizens replicated the global trend, as the peak of the fourth wave corresponded to the time of maximum diffusion of omicron variant (B.1.1.529). Of 771 prevalent dialysis patients at the beginning of the study, 109 (14.1%) contracted SARS-CoV-2 infection during the 4-month observation period. Vaccine adherence in the dialysis population of the reference area was above 95%. Compared to fully or partially vaccinated subjects, the unvaccinated ones showed a significantly higher proportion of infections (12.5% vs. 27.0% p = 0.0341), a more frequent need for hospitalization (22.2% vs. 50.0%) and a 3.3-fold increased mortality risk. These findings confirm the effectiveness of COVID-19 vaccines in keeping infectious risk under control and ameliorating clinical outcomes in immunocompromised patients.

Humoral Response and SARS-CoV-2 Infection Risk following the Third and Fourth Doses of the BNT162b2 Vaccine in Dialysis Patients

The optimal SARS-CoV-2 vaccination schedule in dialysis patients and the potential need for a fourth vaccine dose are debatable. We prospectively assessed the humoral responses to three and four doses of BNT162b2 among dialysis patients. The study included 106 dialysis patients; 60 (56.6%) and 46 (43.4%) received 3 and 4 vaccine doses, respectively. Anti-spike (anti-S) antibody titers significantly increased after the third vaccine dose, followed by a decline, yet still remained higher than all previous measurements. The fourth vaccine dose led to another profound rise in anti-S titers. The absolute increase following the fourth dose correlated with response to the third dose. Infection risk however was similar between patients vaccinated with three or four doses.

Durability of Humoral and Cellular Immunity after an Extended Primary Series with Heterologous Inactivated SARS-CoV-2 Prime-Boost and ChAdOx1 nCoV-19 in Dialysis Patients (ICON3).

The durability of a three-dose extended primary series of COVID-9 vaccine in dialysis patients remains unknown. Here, we assessed dynamic changes in SARS-CoV-2-specific humoral and cell-mediated immunity at baseline, 3 months, and 6 months after the extended primary series in 29 hemodialyzed (HD), 28 peritoneal dialyzed (PD) patients, and 14 healthy controls. Participants received two doses of inactivated SARS-CoV-2 vaccine followed by a dose of ChAdOx1 nCoV-19 vaccine. At 6 months, median anti-RBD IgG titers (IQR) significantly declined from baseline in the HD (1741 (1136–3083) BAU/mL vs. 373 (188–607) BAU/mL) and PD (1093 (617–1911) BAU/mL vs. 180 (126–320) BAU/mL) groups, as did the mean percent inhibition of neutralizing antibodies (HD: 96% vs. 81%; PD: 95% vs. 73%) (all p < 0.01). Age and post-vaccination serological response intensity were predictors of early humoral seroprotection loss. In contrast, cell-mediated immunity remained unchanged. In conclusion, humoral immunity declined substantially in dialysis patients, while cell-mediated immunity remained stable 6 months after the extended heterologous primary series of two inactivated SARS-CoV-2/ChAdOx1 nCoV-19 vaccine. A booster dose could be considered in dialysis patients 3 months after this unique regimen, particularly in the elderly or those with a modest initial humoral response.

Outcome and effect of vaccination in SARS-CoV-2 Omicron infection in hemodialysis patients: a cohort study.

ABSTRACTBackgroundHemodialysis patients are at high risk of Covid-19, though vaccination has significant efficacy in preventing and reducing the severity of infection. Little information is available on disease severity and vaccine efficacy since the dissemination of the Omicron variant.MethodsIn a multi-center study, during a period of the epidemic driven by the Omicron variant, all hemodialysis patients positive for SARS-CoV-2 were identified. Outcomes were analyzed according to predictor variables including vaccination status. Risk of infection was analyzed using a Cox proportional hazards model.ResultsSARS-CoV-2 infection was identified in 1126 patients including 200 (18%) unvaccinated, 56 (5%) post first dose, 433 (38%) post second dose, and 437 (39%) at least 7 days beyond their third dose. The majority of patients had a mild course but 160 (14%) were hospitalized and 28 (2%) died. In regression models adjusted for age and comorbidity, two-dose vaccination was associated with a 39% (95%CI: 2%–62%) reduction in admissions, but third doses provided additional protection, with a 51% (95%CI: 25%–69%) further reduction in admissions. Among 1265 patients at risk at the start of the observation period, SARS-CoV-2 infection was observed in 211 (17%). Two-dose vaccination was associated with a 41% (95%CI: 3%–64%) reduction in the incidence of infection, with no clear additional effect provided by third doses.ConclusionsThese data demonstrate lower incidence of SARS-CoV-2 infection after vaccination in dialysis patients during an Omicron dominant period of the epidemic. Among those developing infection, severe illness was less common with prior vaccination, particularly after third vaccine doses.

SARS-COV-2 vaccine responses in renal patient populations

BackgroundDialysis patients and immunosuppressed renal patients are at increased risk of COVID-19 and were excluded from vaccine trials. We conducted a prospective multicentre study to assess SARS-CoV-2 vaccine antibody responses in dialysis patients and renal transplant recipients, and patients receiving immunosuppression for autoimmune disease.MethodsPatients were recruited from three UK centres (ethics:20/EM/0180) and compared to healthy controls (ethics:17/EE/0025). SARS-CoV-2 IgG antibodies to spike protein were measured using a multiplex Luminex assay, after first and second doses of Pfizer BioNTech BNT162b2(Pfizer) or Oxford-AstraZeneca ChAdOx1nCoV-19(AZ) vaccine.ResultsSix hundred ninety-two patients were included (260 dialysis, 209 transplant, 223 autoimmune disease (prior rituximab 128(57%)) and 144 healthy controls. 299(43%) patients received Pfizer vaccine and 379(55%) received AZ. Following two vaccine doses, positive responses occurred in 96% dialysis, 52% transplant, 70% autoimmune patients and 100% of healthy controls. In dialysis patients, higher antibody responses were observed with the Pfizer vaccination. Predictors of poor antibody response were triple immunosuppression (adjusted odds ratio [aOR]0.016;95%CI0.002–0.13;p < 0.001) and mycophenolate mofetil (MMF) (aOR0.2;95%CI 0.1–0.42;p < 0.001) in transplant patients; rituximab within 12 months in autoimmune patients (aOR0.29;95%CI 0.008–0.096;p < 0.001) and patients receiving immunosuppression with eGFR 15-29 ml/min (aOR0.031;95%CI 0.11–0.84;p = 0.021). Lower antibody responses were associated with a higher chance of a breakthrough infection.ConclusionsAmongst dialysis, kidney transplant and autoimmune populations SARS-CoV-2 vaccine antibody responses are reduced compared to healthy controls. A reduced response to vaccination was associated with rituximab, MMF, triple immunosuppression CKD stage 4. Vaccine responses increased after the second dose, suggesting low-responder groups should be prioritised for repeated vaccination. Greater antibody responses were observed with the mRNA Pfizer vaccine compared to adenovirus AZ vaccine in dialysis patients suggesting that Pfizer SARS-CoV-2 vaccine should be the preferred vaccine choice in this sub-group.

MO180: Reactogenicity of MRNA-1273 Vaccine in Patients on Haemodialysis

BACKGROUND AND AIMSmRNA-1273 vaccine (previously known as vaccine Moderna) has shown 94.1% efficacy at preventing COVID-19 illness in the general population. Vaccine-related adverse events (AEs) were usually mild or moderate in intensity and resolved within a few days. Nevertheless, the fear of developing AEs led some patients on haemodialysis to deny vaccination or additional booster doses. No studies have been conducted to evaluate the reactogenicity of the mRNA-1273 vaccine in dialysis patients. To inform public health and clinical practice, we investigated the safety of the mRNA-1273 vaccine in a cohort of patients on haemodialysis.METHODWe conducted a retrospective analysis of in-centre haemodialysis patients without a prior COVID-19 diagnosis who underwent mRNA-1273 vaccine from 1 March to 30 April 2021. mRNA-1273 vaccine was performed in all patients without signs of ongoing infection or COVID-19 who provided written consent from 24 March to 30 April 2021.AEs occurring after the first and the second doses were collected and classified as local or systemic.RESULTSOverall, 126 patients on chronic maintenance dialysis were vaccinated with two doses of mRNA-1273 vaccine. Mean age was 68 (IQR, 54.7–76) years and 53.6% of patients were aged ≥65 years (Table 1). AEs occurred in 57.9% and 61.9% of patients after the first dose and second dose, respectively. The most common AEs were injection-site pain (61.9%), erythema (4.8%), itching (4.8%), swelling (16.7%), axillary swelling/tenderness (2.4%), fever (17.5%) headache (7.9%), fatigue (23.8%), myalgia (17.5%), arthralgia (12.7%), dyspnoea (2.4%), nausea/vomiting (7.1%), diarrhoea (5.6%), shivers (4%) and vertigo (1.6%).Table 1.Demographic and clinical characteristics of haemodialysis patients who underwent RNA-1273 vaccine administrationBasal characteristicsAll patients(n = 126) Age (year)68 (54.7–6) (range)19–92 ≥ 65 years71 (56.3) Males, n (%)71 (56.31) Ethnic origin, n. (%) Caucasian110 (87.3) African15 (11.9) Hispanic1 (0.8)Etiology of ESRD, n. (%) Nephrosclerosis54 (42.9) Glomerulonephritis26 (20.6) Diabetes14 (11.1) ADPKD4 (3.2) Nephrotoxic4 (3.2) Pyelonephritis4 (3.2) Interstitial3 (2.4) HIVAN2 (1.6) Others10 (7.9) NA5 (4)HD treatment schedule, n (%) 3 times per week115 (91.2) 2 times per week7 (5.5) 4 times per week4 (3.1)Infectious disease, n. (%) HBV3 (2.3) HCV3 (2.3) HIV2 (1.5)Time elapsed from the first to the second dose of vaccine, day28 (28–28)Follow-up, day68 (66–70)ESRD, end-stage renal disease; HBV, hepatitis B virus; HCV, hepatitis C virus.The rates of local AEs were similar after the first and second doses (P = .8), whereas systemic AEs occurred more frequently after the second dose (P = .001). Fever (P = .03), fatigue (P = .02) and nausea/vomiting (P = .03) were significantly more frequent after the second dose of the vaccine (Figure 1). Analysis of the data detected statistically significant differences in duration of axillary swelling/tenderness (P = .07) and diarrhoea (P = .02) between the first and second. In both cases, these symptoms lasted longer after the second dose of the vaccine. There were no age-related differences in the rate of AEs between older (≥65 years) and younger participants (18–64 years). Lastly, we noted a lower rate of AEs in hemodialysis patients after the first dose (57.9% versus 84.2%) and second doses (61.9% versus 88.6%) compared to the general population.FIGURE 1:Number of patients who experienced AEs after the two doses.CONCLUSIONRNA-1273 vaccine was associated with the development of transient AEs after the first (57.9%) and second doses (61.9%) in patients on haemodialysis. Systemic AEs were more common after the second dose than the first dose of vaccine. The duration of AEs lasted for a few days, without any apparent consequences. These data confirm the safety of the RNA-1273 vaccine in haemodialysis patients and support the promotion of COVID-19 vaccination in hesitant patients.

Longevity of Humoral Response Six Months Following BNT162b2 Vaccine in Dialysis Patients.

BackgroundEnd-stage kidney disease substantially increases the risk of severe COVID-19. However, despite early robust immunogenicity of the mRNA-SARS-CoV-2 vaccination in patients with hemodialysis, the longevity of humoral response in this high-risk population is still unknown.MethodsA prospective cohort study aimed to evaluate the longevity of serologic response in patients with hemodialysis, compared with a control group, 6 months following the second dose of the BNT162b2 vaccine. We assessed antibody response by quantitative measurement of IgG antibodies against the receptor-binding domain of the Spike protein (anti-S1-RBD IgG). Study outcomes were defined as a seropositivity rate and log-transformed anti-S1-RBD IgG levels at 6 months, and the change in antibody levels between 3 and 6 months.FindingsThe cohort included 104 patients with hemodialysis and 84 controls. At a median time of 184 days (IQR, 183–188) following the second dose of the vaccine, 83/104 (79.8%) patients with hemodialysis maintained seropositivity for the anti-S1-RBD IgG level compared to 83/84 (98.8%) in the control group (p < 0.001). The log-transformed antibody level was significantly lower in the hemodialysis group (2.23 ± 0.39 log AU/ml vs. 2.69 ± 0.65 log AU/ml, respectively, p < 0.001). Older age and hypoalbuminemia were the only variables that were found to be associated with reduced log-transformed antibody levels in univariate and multivariate analysis. There was no interaction between dialysis status and an antibody-level decline rate (p = 0.972).ConclusionAmong patients with hemodialysis, a seropositivity rate and anti-S1-RBD antibody titers were substantially reduced compared with a control group, at 6 months following the second dose of the BNT162b2 vaccine. These findings support the prioritization of patients with hemodialysis for a third “booster” dose.

Short and mid-term SARS-CoV-2 antibody response after inactivated COVID-19 vaccine in hemodialysis and kidney transplant patients.

The efficacy of the inactivated severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) vaccine has not been fully elucidated across the whole spectrum of patients on kidney replacement therapy. We aimed to characterize the long‐term antibody response of inactivated SARS‐CoV‐2 vaccine administered in kidney transplant recipients (KTRs) and hemodialysis (HD) patients. We performed this prospective observational study in 50 HD, 64 KTR, and 41 healthy control groups (HG) given two doses of CoronaVac. We measured anti‐Spike antibodies after 28 days of every vaccine dose, 3rd and 6th months after the first dose, and compared them between cohorts. After two doses, an anti‐spike immunoglobulin G of ≥50 AU/ml was present in HD, KTR, and HG as 44%, 7.2%, and 58.5%, respectively (p < 0.001). Furthermore, the proportion of antibody titers peaked at 86.5%, 23%, and 97.6% (p < 0.001) at the 3rd month and decreased significantly at the 6th month in most HD and HG participants, whereas this effect was not observed in KTRs from basal until the 6th month (p < 0.001). During the follow‐up, the incidence of coronavirus disease 2019 disease was higher (p < 0.003) in KTRs compared to the other groups, but there was no requirement for an intensive care unit and no death was recorded. We found a negative correlation between antibody seroconversion and age (p < 0.016). The antibody response following inactivated vaccine in dialysis patients is almost comparable to controls for 6 months. In contrast, kidney transplant patients have a poor response. These findings reinforce the need to discuss the vaccination strategy in immunocompromised patients, including the third dose with homologous or heterologous vaccines.

Antibody Response to the Coronavirus Disease 2019 Ad26.COV2.S Vaccine Among Maintenance Dialysis Patients

Antibody Response to the Coronavirus Disease 2019 Ad26.COV2.S Vaccine Among Maintenance Dialysis Patients