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Background and Aim Dialysis 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. Results One 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. Conclusions The present study provides evidence that the homologous SpV/SpV and heterologous SpV/Mod schemes showed good e...

Introduction: The humoral response to vaccines is the most used tool to evaluate the protection against SARS-CoV-2 infection. Dialysis patients are a high-risk population and have a reduced immune response to vaccination. Objective: To assess the humoral response to homologous Gam-COVID-Vac (Sputnik V) and heterologous Sputnik V/mRNA-1273 (Moderna) vaccination in dialysis patients. Methods: SARS-CoV-2 anti-spike IgG (RBD) concentration was estimated 3-16 weeks after complete vaccination. Reactogenicity was evaluated until day 7 by patients self-reported side events. Results: 107 participants were enrolled [n=84 homologous (SpV/SpV), n=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 and gender, previous SARS-COV-2 infection (B: 1944.3; CI95: 1136.2-2753.4; p<0.001), and SpV/Mod vaccination scheme (B: 1241.5; CI95: 420.39-2062.6; 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. Conclusion: The present study provides evidence that the homologous SpV/SpV and heterologous SpV/Mod schemes showed good efficacy and safety under dialysis conditions. These results could be useful for future vaccination strategies, especially aimed at this risk group.

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Introduction.The COVID-19 pandemic has brought to light the need for rapid diagnostic tests. The gold standard test is reverse transcription-polymerase chain reaction (RT-PCR). RT-PCR requires equipment and trained personnel, and results may take a long waiting time. The BD Veritor® System is a rapid chromatographic method used for the detection of severe acute respiratory syndrome coronavirus 2 antigen in symptomatic individuals. The primary objective of this study is to assess the sensitivity and specificity of the antigen test (AT) compared to the RT-PCR in the pediatric population. Population and methods.Prospective study with a diagnostic test. All children younger than 17 years in the first 5 days of symptom onset, who consulted between July 2021 and February 2022, were included. A minimum of 300 specimens was estimated to achieve an accuracy of ±8.76% and ±3.68% for sensitivity and specificity, respectively. Specimens were analyzed in parallel using both methodologies.Results. Of 316 paired samples, 33 were positive by both methods; 6 were positive only by RT-PCR. The specificity of the AT was 100%; sensitivity was 84.6%, with a positive and negative predictive value of 100% and 98%, respectively. Conclusions.The AT proved to be useful in the diagnosis of pediatric patients with COVID-19 in the first 5 days of symptom onset, although those with a negative AT and high clinical suspicion should confirm their result with a RT-PCR.Clinical trial registration: PRIISA.BA -Record number: 4912 -Date of registration: 07/07/2021.