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SAFETY AND EFFECTIVENESS OF COVID-19 SPUTNIK V VACCINE IN DIALYSIS PATIENTS.

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Title: SAFETY AND EFFECTIVENESS OF COVID-19 SPUTNIK V VACCINE IN DIALYSIS PATIENTS.
Alternate Title: Seguridad y efectividad de vacuna COVID-19 SPUTNIK V en pacientes en diálisis.
Authors: ROSA-DIEZ, GUILLERMO1 guillermo.rosadiez@hospitalitaliano.org.ar, PAPAGINOVIC LEIVA, MARÍA MARINA2, LOMBI, FERNANDO3, CRUCELEGUI, MARÍA SOLEDAD1, MARTÍNEZ, RICARDO D.2, TRIMARCHI, HERNÁN3, SCHIAVELLI, RUBÉN4, GRIZZO, MERCEDES4, RAÑO, MIGUEL4, HEGUILÉN, RICARDO M.5, JONES, ROCÍO A.5, GONZÁLEZ PAGANTI, LUCIANA6, FERRRARI, MATÍAS6, KJOHEDE, VICTORIA7, ZINGONI, PAULA8, GEFFNER, JORGE R.7, FERRANTE, DANIEL8, BERNALDO DE QUIRÓS, FERNÁN GONZÁLEZ8, PAGOTTO, VANINA9
Source: Medicina (Buenos Aires). sep/oct2022, Vol. 82 Issue 5, p631-640. 10p.
Subjects: CHRONIC kidney failure, CORONAVIRUS diseases, VACCINES, HEMODIALYSIS, SARS disease, SERODIAGNOSIS
Abstract (English): Introduction: Given the vulnerability of chronic kidney disease individuals to SARS-CoV-2, nephrology societies have issued statements calling for prioritization of these patients for vaccination. It is not yet known whether COVID-19 vaccines grant the same high level of protection in patients with kidney disease compared to the non-dialysis population. The aims of this study were to evaluate the safety - measured by the adverse events potentially attributed to vaccines (ESAVI) - and the effectiveness - evaluated by the presence of antibodies - in dialysis patients immunized with the COVID-19 Sputnik V vaccine. Methods: multicenter, observational and analytical study of a prospective cohort of hemodialysis patients from the Ciudad Autónoma de Buenos Aires participating in an official vaccination program. Dialysis requiring individuals older than 18 years, who received both components of the COVID-19 vaccine were included. Results: Data from 491 patients were included in the safety analysis. ESAVI with either the first or second component was detected in 186 (37.9%, 95% CI 33.6%-42.3%). Effectiveness analysis measuring antibodies levels against SARS-CoV-2 were performed in 102 patients; 98% presented these IgG antibodies at day 21 after the second component. In patients with COVID-19 prior to vaccination, antibodies at day 21 after the first component reached almost the highest levels compared to patients without previous COVID-19, but IgG rise among patients with previous COVID-19 was lower than in those without this previous disease. Conclusion: The Sputnik V vaccine has been shown to be safe and effective in this patient's population. [ABSTRACT FROM AUTHOR]
Abstract (Spanish): Dada la vulnerabilidad al SARS-CoV-2 de las personas con enfermedad renal crónica, las sociedades de nefrología han emitido declaraciones pidiendo priorizar a estos pacientes para la vacunación. Aún no se sabe si las vacunas COVID-19 confieren el mismo nivel de protección en pacientes con enfermedad renal. Los objetivos de este estudio fueron evaluar la seguridad, medida por eventos supuestamente atribuidos a las vacunas (ESAVI) y la efectividad, evaluada por la presencia de anticuerpos en pacientes en diálisis inmunizados con la vacuna COVID-19 Sputnik V. Métodos: estudio multicéntrico, observacional y analítico de una cohorte prospectiva de pacientes en hemodiálisis, en la Ciudad Autónoma de Buenos Aires, con plan de vacunación. Se incluyeron pacientes mayores de 18 años en diálisis que recibieron ambos componentes de la vacuna COVID-19. Resultados: 491 pacientes fueron incluidos en el análisis de seguridad. Se detectó ESAVI con el primer o el segundo componente en 186 (37.9% IC 95%: 33.6%-42.3%). La efectividad medida por presencia de anticuerpos IgG contra SARS-Cov-2 se realizó en 102 pacientes, 98% presentaba IgG contra SARS-CoV-2, 21 días después del segundo componente. En pacientes con COVID-19 previo a la vacunación, los anticuerpos al día 21 del primer componente alcanzaron niveles casi mayores que en aquellos que no habían sufrido COVID-19, aunque el aumento de los niveles a los 21 días del segundo componente fue menor que en los pacientes sin COVID-19 previo. Conclusión: Los pacientes en diálisis constituyen una población vulnerable para la infección por SARS-CoV-2, por lo tanto, más allá de las recomendaciones implementadas por las unidades de diálisis, la vacunación completa es mandatoria. Se ha demostrado que la vacuna Sputnik V es segura y eficaz en esta población de pacientes. [ABSTRACT FROM AUTHOR]
Copyright of Medicina (Buenos Aires) is the property of Medicina (Buenos Aires) and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: MedicLatina
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  Data: SAFETY AND EFFECTIVENESS OF COVID-19 SPUTNIK V VACCINE IN DIALYSIS PATIENTS.
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  Data: Seguridad y efectividad de vacuna COVID-19 SPUTNIK V en pacientes en diálisis.
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  Data: <searchLink fieldCode="AR" term="%22ROSA-DIEZ%2C+GUILLERMO%22">ROSA-DIEZ, GUILLERMO</searchLink><relatesTo>1</relatesTo><i> guillermo.rosadiez@hospitalitaliano.org.ar</i><br /><searchLink fieldCode="AR" term="%22PAPAGINOVIC+LEIVA%2C+MARÍA+MARINA%22">PAPAGINOVIC LEIVA, MARÍA MARINA</searchLink><relatesTo>2</relatesTo><br /><searchLink fieldCode="AR" term="%22LOMBI%2C+FERNANDO%22">LOMBI, FERNANDO</searchLink><relatesTo>3</relatesTo><br /><searchLink fieldCode="AR" term="%22CRUCELEGUI%2C+MARÍA+SOLEDAD%22">CRUCELEGUI, MARÍA SOLEDAD</searchLink><relatesTo>1</relatesTo><br /><searchLink fieldCode="AR" term="%22MARTÍNEZ%2C+RICARDO+D%2E%22">MARTÍNEZ, RICARDO D.</searchLink><relatesTo>2</relatesTo><br /><searchLink fieldCode="AR" term="%22TRIMARCHI%2C+HERNÁN%22">TRIMARCHI, HERNÁN</searchLink><relatesTo>3</relatesTo><br /><searchLink fieldCode="AR" term="%22SCHIAVELLI%2C+RUBÉN%22">SCHIAVELLI, RUBÉN</searchLink><relatesTo>4</relatesTo><br /><searchLink fieldCode="AR" term="%22GRIZZO%2C+MERCEDES%22">GRIZZO, MERCEDES</searchLink><relatesTo>4</relatesTo><br /><searchLink fieldCode="AR" term="%22RAÑO%2C+MIGUEL%22">RAÑO, MIGUEL</searchLink><relatesTo>4</relatesTo><br /><searchLink fieldCode="AR" term="%22HEGUILÉN%2C+RICARDO+M%2E%22">HEGUILÉN, RICARDO M.</searchLink><relatesTo>5</relatesTo><br /><searchLink fieldCode="AR" term="%22JONES%2C+ROCÍO+A%2E%22">JONES, ROCÍO A.</searchLink><relatesTo>5</relatesTo><br /><searchLink fieldCode="AR" term="%22GONZÁLEZ+PAGANTI%2C+LUCIANA%22">GONZÁLEZ PAGANTI, LUCIANA</searchLink><relatesTo>6</relatesTo><br /><searchLink fieldCode="AR" term="%22FERRRARI%2C+MATÍAS%22">FERRRARI, MATÍAS</searchLink><relatesTo>6</relatesTo><br /><searchLink fieldCode="AR" term="%22KJOHEDE%2C+VICTORIA%22">KJOHEDE, VICTORIA</searchLink><relatesTo>7</relatesTo><br /><searchLink fieldCode="AR" term="%22ZINGONI%2C+PAULA%22">ZINGONI, PAULA</searchLink><relatesTo>8</relatesTo><br /><searchLink fieldCode="AR" term="%22GEFFNER%2C+JORGE+R%2E%22">GEFFNER, JORGE R.</searchLink><relatesTo>7</relatesTo><br /><searchLink fieldCode="AR" term="%22FERRANTE%2C+DANIEL%22">FERRANTE, DANIEL</searchLink><relatesTo>8</relatesTo><br /><searchLink fieldCode="AR" term="%22BERNALDO+DE+QUIRÓS%2C+FERNÁN+GONZÁLEZ%22">BERNALDO DE QUIRÓS, FERNÁN GONZÁLEZ</searchLink><relatesTo>8</relatesTo><br /><searchLink fieldCode="AR" term="%22PAGOTTO%2C+VANINA%22">PAGOTTO, VANINA</searchLink><relatesTo>9</relatesTo>
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  Data: <searchLink fieldCode="JN" term="%22Medicina+%28Buenos+Aires%29%22">Medicina (Buenos Aires)</searchLink>. sep/oct2022, Vol. 82 Issue 5, p631-640. 10p.
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  Data: <searchLink fieldCode="DE" term="%22CHRONIC+kidney+failure%22">CHRONIC kidney failure</searchLink><br /><searchLink fieldCode="DE" term="%22CORONAVIRUS+diseases%22">CORONAVIRUS diseases</searchLink><br /><searchLink fieldCode="DE" term="%22VACCINES%22">VACCINES</searchLink><br /><searchLink fieldCode="DE" term="%22HEMODIALYSIS%22">HEMODIALYSIS</searchLink><br /><searchLink fieldCode="DE" term="%22SARS+disease%22">SARS disease</searchLink><br /><searchLink fieldCode="DE" term="%22SERODIAGNOSIS%22">SERODIAGNOSIS</searchLink>
– Name: Abstract
  Label: Abstract (English)
  Group: Ab
  Data: Introduction: Given the vulnerability of chronic kidney disease individuals to SARS-CoV-2, nephrology societies have issued statements calling for prioritization of these patients for vaccination. It is not yet known whether COVID-19 vaccines grant the same high level of protection in patients with kidney disease compared to the non-dialysis population. The aims of this study were to evaluate the safety - measured by the adverse events potentially attributed to vaccines (ESAVI) - and the effectiveness - evaluated by the presence of antibodies - in dialysis patients immunized with the COVID-19 Sputnik V vaccine. Methods: multicenter, observational and analytical study of a prospective cohort of hemodialysis patients from the Ciudad Autónoma de Buenos Aires participating in an official vaccination program. Dialysis requiring individuals older than 18 years, who received both components of the COVID-19 vaccine were included. Results: Data from 491 patients were included in the safety analysis. ESAVI with either the first or second component was detected in 186 (37.9%, 95% CI 33.6%-42.3%). Effectiveness analysis measuring antibodies levels against SARS-CoV-2 were performed in 102 patients; 98% presented these IgG antibodies at day 21 after the second component. In patients with COVID-19 prior to vaccination, antibodies at day 21 after the first component reached almost the highest levels compared to patients without previous COVID-19, but IgG rise among patients with previous COVID-19 was lower than in those without this previous disease. Conclusion: The Sputnik V vaccine has been shown to be safe and effective in this patient's population. [ABSTRACT FROM AUTHOR]
– Name: Abstract
  Label: Abstract (Spanish)
  Group: Ab
  Data: Dada la vulnerabilidad al SARS-CoV-2 de las personas con enfermedad renal crónica, las sociedades de nefrología han emitido declaraciones pidiendo priorizar a estos pacientes para la vacunación. Aún no se sabe si las vacunas COVID-19 confieren el mismo nivel de protección en pacientes con enfermedad renal. Los objetivos de este estudio fueron evaluar la seguridad, medida por eventos supuestamente atribuidos a las vacunas (ESAVI) y la efectividad, evaluada por la presencia de anticuerpos en pacientes en diálisis inmunizados con la vacuna COVID-19 Sputnik V. Métodos: estudio multicéntrico, observacional y analítico de una cohorte prospectiva de pacientes en hemodiálisis, en la Ciudad Autónoma de Buenos Aires, con plan de vacunación. Se incluyeron pacientes mayores de 18 años en diálisis que recibieron ambos componentes de la vacuna COVID-19. Resultados: 491 pacientes fueron incluidos en el análisis de seguridad. Se detectó ESAVI con el primer o el segundo componente en 186 (37.9% IC 95%: 33.6%-42.3%). La efectividad medida por presencia de anticuerpos IgG contra SARS-Cov-2 se realizó en 102 pacientes, 98% presentaba IgG contra SARS-CoV-2, 21 días después del segundo componente. En pacientes con COVID-19 previo a la vacunación, los anticuerpos al día 21 del primer componente alcanzaron niveles casi mayores que en aquellos que no habían sufrido COVID-19, aunque el aumento de los niveles a los 21 días del segundo componente fue menor que en los pacientes sin COVID-19 previo. Conclusión: Los pacientes en diálisis constituyen una población vulnerable para la infección por SARS-CoV-2, por lo tanto, más allá de las recomendaciones implementadas por las unidades de diálisis, la vacunación completa es mandatoria. Se ha demostrado que la vacuna Sputnik V es segura y eficaz en esta población de pacientes. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Medicina (Buenos Aires) is the property of Medicina (Buenos Aires) and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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