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Autor Isabel Cristina Ramírez Sánchez
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Médica Internista Infectóloga, Hospital Pablo Tobón Uribe
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Documentos disponibles escritos por este autor (29)
Clasificado(s) por (Año de edición descendente) Refinar búsquedaImmunogenicity and safety of booster CYD-TDV dengue vaccine after alternative primary vaccination schedules in healthy individuals aged 9–50 years: a randomised, controlled, phase 2, non-inferiority study / Isabel Cristina Ramírez Sánchez
Título : Immunogenicity and safety of booster CYD-TDV dengue vaccine after alternative primary vaccination schedules in healthy individuals aged 9–50 years: a randomised, controlled, phase 2, non-inferiority study Tipo de documento : documento electrónico Autores : Isabel Cristina Ramírez Sánchez, Fecha de publicación : 2022 Títulos uniformes : The Lancet Infectious Diseases Idioma : Inglés (eng) Resumen : Background: Dengue is endemic in many countries throughout the tropics and subtropics, and the disease causes substantial morbidity and health-care burdens in these regions. We previously compared antibody responses after one-dose, two-dose, or three-dose primary regimens with the only approved dengue vaccine CYD-TDV (Dengvaxia; Sanofi Pasteur, Lyon, France) in individuals aged 9 years and older with previous dengue exposure. In this study, we assessed the need for a CYD-TDV booster after these primary vaccination regimens. Methods: In this randomised, controlled, phase 2, non-inferiority study, healthy individuals aged 9–50 years recruited from three sites in Colombia and three sites in the Philippines (excluding those with the usual contraindications to vaccinations) were randomly assigned 1:1:1 via a permuted block method with stratification by site and by age group using an independent voice response system to receive, at 6-month intervals, three doses of CYD-TDV (three-dose group), one dose of placebo followed by two doses of CYD-TDV (two-dose group), or two doses of placebo followed by one dose of CYD-TDV (one-dose group). Participants were also randomly assigned (1:1) to receive a CYD-TDV booster at 1 year or 2 years after the last primary dose. Each CYD-TDV dose was 0·5 mL and administered subcutaneously in the deltoid region of the upper arm. The investigators and sponsor, study staff interacting with the investigators, and participants and their parents or legally acceptable representatives were masked to group assignment. Neutralising antibodies were measured by 50% plaque reduction neutralisation testing, and geometric mean titres (GMTs) were calculated. Due to a change in study protocol, only participants who were dengue seropositive at baseline in the Colombian cohort received a booster vaccination. The primary outcome was to show non-inferiority of the booster dose administered at 1 year or 2 years after the two-dose and three-dose primary regimens; non-inferiority was shown if the lower limit of the two-sided adjusted 95% CI of the between-group (day 28 post-booster dose GMT from the three-dose or two-dose group vs day 28 GMT post-dose three of the three-dose primary regimen [three-dose group]) geometric mean ratio (GMR) was higher than 0·5 for each serotype. Non-inferiority of the 1-year or 2-year booster was shown if all four serotypes achieved non-inferiority. Safety was assessed among all participants who received the booster. This trial is registered with ClinicalTrials.gov, NCT02628444, and is closed to accrual. Findings: Between May 2 and Sept 16, 2016, we recruited and enrolled 1050 individuals who received either vaccine or placebo. Of the 350, 348, and 352 individuals randomly assigned to three-dose, two-dose, and one-dose groups, respectively, 108, 115, and 115 from the Colombian cohort were dengue seropositive at baseline and received a booster; 55 and 53 in the three-dose group received a booster after 1 year and 2 years, respectively, as did 59 and 56 in the two-dose group, and 62 and 53 in the one-dose group. After the three-dose primary schedule, non-inferiority was shown for serotypes 2 (GMR 0·746; 95% CI 0·550–1·010) and 3 (1·040; 0·686–1·570) but not serotypes 1 (0·567; 0·399–0·805) and 4 (0·647; 0·434–0·963) for the 1-year booster, and again for serotypes 2 (0·871; 0·673–1·130) and 3 (1·150; 0·887–1·490) but not serotypes 1 (0·688; 0·479–0·989) and 4 (0·655; 0·471–0·911) for the 2-year booster. Similarly, after the two-dose primary schedule, non-inferiority was shown for serotypes 2 (0·809; 0·505–1·300) and 3 (1·19; 0·732–1·940) but not serotypes 1 (0·627; 0·342–1·150) and 4 (0·499; 0·331–0·754) for the 1-year booster, and for serotype 3 (0·911; 0·573–1·450) but not serotypes 1 (0·889; 0·462–1·710), 2 (0·677; 0·402–1·140), and 4 (0·702; 0·447–1·100) for the 2-year booster. Thus, non-inferiority of the 1-year or 2-year booster was not shown after the three-dose or two-dose primary vaccination regimen in dengue-seropositive participants. No safety concerns occurred with the 1-year or 2-year CYD-TDV booster. Interpretation: CYD-TDV booster 1 year or 2 years after the two-dose or three-dose primary vaccination regimen does not elicit a consistent, meaningful booster effect against all dengue serotypes in participants who are seropositive for dengue at baseline. Mención de responsabilidad : Diana Leticia Coronel-Martinez, Juliana Park, Eduardo López-Medina, María Rosario Capeding, Andrés Angelo Cadena Bonfanti, María Cecilia Montalbán, Isabel Ramírez, María Liza Antoinette Gonzales, Betzana Zambrano, Gustavo Dayan, Zhenghong Chen, Hao Wang, Matthew Bonaparte, Andrey Rojas, Jenny Carolina Ramírez, Mae Ann Verdan, Fernando Noriega Referencia : Lancet Infect Dis. 2022 Jun;22(6):901-911. DOI (Digital Object Identifier) : 10.1016/S1473-3099(21)00706-4 PMID : 35364022 En línea : https://linkinghub.elsevier.com/retrieve/pii/S1473309921007064 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=6018 Immunogenicity and safety of booster CYD-TDV dengue vaccine after alternative primary vaccination schedules in healthy individuals aged 9–50 years: a randomised, controlled, phase 2, non-inferiority study [documento electrónico] / Isabel Cristina Ramírez Sánchez, . - 2022.
Obra : The Lancet Infectious Diseases
Idioma : Inglés (eng)
Resumen : Background: Dengue is endemic in many countries throughout the tropics and subtropics, and the disease causes substantial morbidity and health-care burdens in these regions. We previously compared antibody responses after one-dose, two-dose, or three-dose primary regimens with the only approved dengue vaccine CYD-TDV (Dengvaxia; Sanofi Pasteur, Lyon, France) in individuals aged 9 years and older with previous dengue exposure. In this study, we assessed the need for a CYD-TDV booster after these primary vaccination regimens. Methods: In this randomised, controlled, phase 2, non-inferiority study, healthy individuals aged 9–50 years recruited from three sites in Colombia and three sites in the Philippines (excluding those with the usual contraindications to vaccinations) were randomly assigned 1:1:1 via a permuted block method with stratification by site and by age group using an independent voice response system to receive, at 6-month intervals, three doses of CYD-TDV (three-dose group), one dose of placebo followed by two doses of CYD-TDV (two-dose group), or two doses of placebo followed by one dose of CYD-TDV (one-dose group). Participants were also randomly assigned (1:1) to receive a CYD-TDV booster at 1 year or 2 years after the last primary dose. Each CYD-TDV dose was 0·5 mL and administered subcutaneously in the deltoid region of the upper arm. The investigators and sponsor, study staff interacting with the investigators, and participants and their parents or legally acceptable representatives were masked to group assignment. Neutralising antibodies were measured by 50% plaque reduction neutralisation testing, and geometric mean titres (GMTs) were calculated. Due to a change in study protocol, only participants who were dengue seropositive at baseline in the Colombian cohort received a booster vaccination. The primary outcome was to show non-inferiority of the booster dose administered at 1 year or 2 years after the two-dose and three-dose primary regimens; non-inferiority was shown if the lower limit of the two-sided adjusted 95% CI of the between-group (day 28 post-booster dose GMT from the three-dose or two-dose group vs day 28 GMT post-dose three of the three-dose primary regimen [three-dose group]) geometric mean ratio (GMR) was higher than 0·5 for each serotype. Non-inferiority of the 1-year or 2-year booster was shown if all four serotypes achieved non-inferiority. Safety was assessed among all participants who received the booster. This trial is registered with ClinicalTrials.gov, NCT02628444, and is closed to accrual. Findings: Between May 2 and Sept 16, 2016, we recruited and enrolled 1050 individuals who received either vaccine or placebo. Of the 350, 348, and 352 individuals randomly assigned to three-dose, two-dose, and one-dose groups, respectively, 108, 115, and 115 from the Colombian cohort were dengue seropositive at baseline and received a booster; 55 and 53 in the three-dose group received a booster after 1 year and 2 years, respectively, as did 59 and 56 in the two-dose group, and 62 and 53 in the one-dose group. After the three-dose primary schedule, non-inferiority was shown for serotypes 2 (GMR 0·746; 95% CI 0·550–1·010) and 3 (1·040; 0·686–1·570) but not serotypes 1 (0·567; 0·399–0·805) and 4 (0·647; 0·434–0·963) for the 1-year booster, and again for serotypes 2 (0·871; 0·673–1·130) and 3 (1·150; 0·887–1·490) but not serotypes 1 (0·688; 0·479–0·989) and 4 (0·655; 0·471–0·911) for the 2-year booster. Similarly, after the two-dose primary schedule, non-inferiority was shown for serotypes 2 (0·809; 0·505–1·300) and 3 (1·19; 0·732–1·940) but not serotypes 1 (0·627; 0·342–1·150) and 4 (0·499; 0·331–0·754) for the 1-year booster, and for serotype 3 (0·911; 0·573–1·450) but not serotypes 1 (0·889; 0·462–1·710), 2 (0·677; 0·402–1·140), and 4 (0·702; 0·447–1·100) for the 2-year booster. Thus, non-inferiority of the 1-year or 2-year booster was not shown after the three-dose or two-dose primary vaccination regimen in dengue-seropositive participants. No safety concerns occurred with the 1-year or 2-year CYD-TDV booster. Interpretation: CYD-TDV booster 1 year or 2 years after the two-dose or three-dose primary vaccination regimen does not elicit a consistent, meaningful booster effect against all dengue serotypes in participants who are seropositive for dengue at baseline. Mención de responsabilidad : Diana Leticia Coronel-Martinez, Juliana Park, Eduardo López-Medina, María Rosario Capeding, Andrés Angelo Cadena Bonfanti, María Cecilia Montalbán, Isabel Ramírez, María Liza Antoinette Gonzales, Betzana Zambrano, Gustavo Dayan, Zhenghong Chen, Hao Wang, Matthew Bonaparte, Andrey Rojas, Jenny Carolina Ramírez, Mae Ann Verdan, Fernando Noriega Referencia : Lancet Infect Dis. 2022 Jun;22(6):901-911. DOI (Digital Object Identifier) : 10.1016/S1473-3099(21)00706-4 PMID : 35364022 En línea : https://linkinghub.elsevier.com/retrieve/pii/S1473309921007064 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=6018 Reserva
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Título : Tiroiditis subaguda y tirotoxicosis posterior a vacuna contra SARS-CoV-2: reporte de 2 casos Otros títulos : Subacute thyroiditis and thyrotoxicosis after SARS-CoV-2 vaccine: report of 2 cases Tipo de documento : documento electrónico Autores : Isabel Cristina Ramírez Sánchez, ; Carlos Esteban Builes Montaño, ; Alejandro Vélez Hoyos, Fecha de publicación : 2022 Títulos uniformes : Medicina & Laboratorio Idioma : Español (spa) Palabras clave : COVID-19 vacuna ARN mensajero adenovirus tiroiditis bocio Resumen : La enfermedad por coronavirus SARS-CoV-2 que surgió en el año 2019 (COVID-19), ha obligado al rápido desarrollo de vacunas para prevenir su propagación e intentar controlar la pandemia. Dentro de las vacunas desarrolladas, las primeras en ser aprobadas con una tecnología nueva en el campo de la vacunación, fueron las vacunas basadas en ARNm (ácido ribonucleico mensajero), que lograron tasas de efectividad cercanas al 95 % para la prevención de la enfermedad COVID-19 grave. Los eventos adversos comunes son reacciones locales leves, pero ha habido varios informes de pacientes que desarrollaron tiroiditis subaguda y disfunción tiroidea después de recibir la vacuna contra SARS-CoV-2. Este artículo presenta dos casos de tiroiditis subaguda poco después de recibir la vacuna contra COVID-19. Mención de responsabilidad : Myriam Vanessa Rueda-Galvis, Isabel Cristina Ramírez-Sánchez, Carlos E. Builes-Montaño, Alejandro Vélez-Hoyos DOI (Digital Object Identifier) : 10.36384/01232576.609 Derechos de uso : CC BY-NC-ND En línea : https://medicinaylaboratorio.com/index.php/myl/article/view/609 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=6062 Tiroiditis subaguda y tirotoxicosis posterior a vacuna contra SARS-CoV-2: reporte de 2 casos = Subacute thyroiditis and thyrotoxicosis after SARS-CoV-2 vaccine: report of 2 cases [documento electrónico] / Isabel Cristina Ramírez Sánchez, ; Carlos Esteban Builes Montaño, ; Alejandro Vélez Hoyos, . - 2022.
Obra : Medicina & Laboratorio
Idioma : Español (spa)
Palabras clave : COVID-19 vacuna ARN mensajero adenovirus tiroiditis bocio Resumen : La enfermedad por coronavirus SARS-CoV-2 que surgió en el año 2019 (COVID-19), ha obligado al rápido desarrollo de vacunas para prevenir su propagación e intentar controlar la pandemia. Dentro de las vacunas desarrolladas, las primeras en ser aprobadas con una tecnología nueva en el campo de la vacunación, fueron las vacunas basadas en ARNm (ácido ribonucleico mensajero), que lograron tasas de efectividad cercanas al 95 % para la prevención de la enfermedad COVID-19 grave. Los eventos adversos comunes son reacciones locales leves, pero ha habido varios informes de pacientes que desarrollaron tiroiditis subaguda y disfunción tiroidea después de recibir la vacuna contra SARS-CoV-2. Este artículo presenta dos casos de tiroiditis subaguda poco después de recibir la vacuna contra COVID-19. Mención de responsabilidad : Myriam Vanessa Rueda-Galvis, Isabel Cristina Ramírez-Sánchez, Carlos E. Builes-Montaño, Alejandro Vélez-Hoyos DOI (Digital Object Identifier) : 10.36384/01232576.609 Derechos de uso : CC BY-NC-ND En línea : https://medicinaylaboratorio.com/index.php/myl/article/view/609 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=6062 Reserva
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Título : Trasplante renal en pacientes con infección por el virus de la inmunodeficiencia humana: revisión de la literatura Otros títulos : Renal transplantation in patients with human immunodeficiency virus infection: a literature review Tipo de documento : documento electrónico Autores : John Fredy Nieto Ríos, ; Arbey Aristizabal Álzate, ; Gustavo Adolfo Zuluaga Valencia, ; Isabel Cristina Ramírez Sánchez, Fecha de publicación : 2022 Títulos uniformes : Iatreia Idioma : Español (spa) Palabras clave : Insuficiencia Renal Crónica Síndrome de Inmunodeficiencia Adquirida Trasplante de Riñón VIH Resumen : El trasplante renal es el tratamiento de elección en la enfermedad renal crónica terminal porque mejora la calidad de vida y la supervivencia de los pacientes al compararlo con la diálisis. Sin embargo, para mantener un injerto funcional y evitar el rechazo es necesario el uso de inmunosupresión potente durante toda la vida del injerto, lo cual puede tener como complicaciones una mayor susceptibilidad a presentar infecciones, desarrollo de cáncer, alteraciones metabólicas y problemas cardiovasculares. Los pacientes infectados con el virus de la inmunodeficiencia humana tienen alto riesgo de desarrollar enfermedad renal crónica terminal por múltiples causas. En el siglo pasado, el trasplante renal se consideraba contraindicado para estos pacientes. No obstante, hoy en día el trasplante renal se considera una opción terapéutica para pacientes adecuadamente seleccionados y con protocolos de manejo bien establecidos. Reportándose supervivencia reportadas del injerto y del paciente a tres años de 88,2 % y 82,6 % respectivamente. Este artículo de revisión tiene como objetivo revisar la experiencia mundial existente en el manejo de los pacientes trasplantados renal con infección por VIH. Mención de responsabilidad : John Fredy Nieto-Ríos, Natalia Rodríguez-Botero, Arbey Aristizábal-Alzate, Gustavo Adolfo Zuluaga-Valencia, Isabel Cristina Ramírez-Sánchez, Lina María Serna-Higuita Referencia : 10.17533/10.17533/udea.iatreia.144 Derechos de uso : CC BY-NC-SA En línea : https://revistas.udea.edu.co/index.php/iatreia/article/view/346495 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=5823 Trasplante renal en pacientes con infección por el virus de la inmunodeficiencia humana: revisión de la literatura = Renal transplantation in patients with human immunodeficiency virus infection: a literature review [documento electrónico] / John Fredy Nieto Ríos, ; Arbey Aristizabal Álzate, ; Gustavo Adolfo Zuluaga Valencia, ; Isabel Cristina Ramírez Sánchez, . - 2022.
Obra : Iatreia
Idioma : Español (spa)
Palabras clave : Insuficiencia Renal Crónica Síndrome de Inmunodeficiencia Adquirida Trasplante de Riñón VIH Resumen : El trasplante renal es el tratamiento de elección en la enfermedad renal crónica terminal porque mejora la calidad de vida y la supervivencia de los pacientes al compararlo con la diálisis. Sin embargo, para mantener un injerto funcional y evitar el rechazo es necesario el uso de inmunosupresión potente durante toda la vida del injerto, lo cual puede tener como complicaciones una mayor susceptibilidad a presentar infecciones, desarrollo de cáncer, alteraciones metabólicas y problemas cardiovasculares. Los pacientes infectados con el virus de la inmunodeficiencia humana tienen alto riesgo de desarrollar enfermedad renal crónica terminal por múltiples causas. En el siglo pasado, el trasplante renal se consideraba contraindicado para estos pacientes. No obstante, hoy en día el trasplante renal se considera una opción terapéutica para pacientes adecuadamente seleccionados y con protocolos de manejo bien establecidos. Reportándose supervivencia reportadas del injerto y del paciente a tres años de 88,2 % y 82,6 % respectivamente. Este artículo de revisión tiene como objetivo revisar la experiencia mundial existente en el manejo de los pacientes trasplantados renal con infección por VIH. Mención de responsabilidad : John Fredy Nieto-Ríos, Natalia Rodríguez-Botero, Arbey Aristizábal-Alzate, Gustavo Adolfo Zuluaga-Valencia, Isabel Cristina Ramírez-Sánchez, Lina María Serna-Higuita Referencia : 10.17533/10.17533/udea.iatreia.144 Derechos de uso : CC BY-NC-SA En línea : https://revistas.udea.edu.co/index.php/iatreia/article/view/346495 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=5823 Reserva
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Título : Endocarditis by Fusarium keratoplasticum Tipo de documento : documento electrónico Autores : Isabel Cristina Ramírez Sánchez, Fecha de publicación : 2021 Títulos uniformes : Mycopathologia Idioma : Inglés (eng) Mención de responsabilidad : Juan Sebastián Peinado-Acevedo & Isabel Cristina Ramírez-Sánchez Referencia : Mycopathologia. 2021 Mar;186(1):131-133. DOI (Digital Object Identifier) : 10.1007/s11046-020-00502-4 PMID : 33141374 En línea : https://link.springer.com/article/10.1007/s11046-020-00502-4 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=5155 Endocarditis by Fusarium keratoplasticum [documento electrónico] / Isabel Cristina Ramírez Sánchez, . - 2021.
Obra : Mycopathologia
Idioma : Inglés (eng)
Mención de responsabilidad : Juan Sebastián Peinado-Acevedo & Isabel Cristina Ramírez-Sánchez Referencia : Mycopathologia. 2021 Mar;186(1):131-133. DOI (Digital Object Identifier) : 10.1007/s11046-020-00502-4 PMID : 33141374 En línea : https://link.springer.com/article/10.1007/s11046-020-00502-4 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=5155 Reserva
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Título : Immunogenicity and safety of simplified vaccination schedules for the CYD-TDV dengue vaccine in healthy individuals aged 9-50 years (CYD65): a randomised, controlled, phase 2, non-inferiority study. Tipo de documento : documento electrónico Autores : Isabel Cristina Ramírez Sánchez, Fecha de publicación : 2021 Títulos uniformes : The Lancet Infectious Diseases Idioma : Inglés (eng) Resumen : Background: Three doses of the licensed tetravalent dengue vaccine CYD-TDV (Dengvaxia, Sanofi Pasteur, Lyon France) are immunogenic and effective against symptomatic dengue in individuals aged 9 years and older who are dengue seropositive. Previous trials have provided some evidence that antibody responses elicited after just one dose or two doses of CYD-TDV might be similar to those elicited after three doses. We compared antibody responses following one-dose, two-dose, and three-dose vaccination regimens in individuals who were dengue seropositive at baseline up to 1 year after the last injection. Methods: In this randomised, controlled, phase 2, non-inferiority study (CYD65), healthy individuals aged 9–50 years were recruited from the community in three sites in Colombia and three sites in the Philippines. Participants were randomly assigned (1:1:1), using a permuted block method with stratification by site and age group, to receive, at 6-month intervals (on day 0, month 6, and month 12), three doses of CYD-TDV (three-dose group), one dose of placebo (on day 0) and two doses of CYD-TDV (at months 6 and 12; two-dose group), or two doses of placebo (on day 0 and month 6) and one dose of CYD-TDV (at month 12; one-dose group). Each dose of CYD-TDV was 0·5 mL, administered subcutaneously into the deltoid of the upper arm. Participants, study staff, investigators, and the funder were masked to group assignment. The co-primary endpoints were geometric mean titres (GMTs) of neutralising antibodies against each dengue virus serotype at 28 days and 1 year after the last vaccine injection. After a protocol amendment during the conduct of the study, the original co-primary objectives of non-inferiority of the one-dose and two-dose groups to the three-dose group were altered to include non-inferiority of the two-dose group to the three-dose group only, to be assessed in individuals who were dengue seropositive at baseline. Non-inferiority was shown if the lower limit of the 95% CI for the ratio of GMTs (GMR) at 28 days and 1 year between groups was more than 0·5 for each serotype. The analysis of the coprimary objectives was done in the per-protocol analysis dataset, which included all participants who had been vaccinated, had no protocol deviations, and had a valid serology test result for at least one dengue serotype at 28 days after the third injection. Safety was assessed throughout in all participants who received at least one injection of study drug, regardless of serostatus. This trial is registered with ClinicalTrials.gov, NCT02628444, and is closed to accrual. Findings: Between May 2, 2016, and Sept 16, 2016, we recruited and enrolled 1050 individuals, of whom 1048 received at least one injection and 993 had at least one blood sample taken (full-analysis dataset; 333 in three-dose group, 328 in two-dose group, and 332 in one-dose group). 860 (86·6%) of 993 participants in the full-analysis dataset were dengue seropositive at baseline. Non-inferiority (two dose vs three dose) was shown for each serotype at both 28 days and 1 year among dengue-seropositive participants (number of participants assessed: 272 [two-dose group], 265 [three-dose group] at 28 days; and 190 [two-dose group], 185 [three-dose group] at 1 year). At 28 days after the last injection, neutralising antibody GMTs were 899 (95% CI 752–1075) in the two-dose group versus 822 (700–964) in the three dose group against dengue serotype 1 (GMR 1·09 [95% CI 0·86–1·39]); 869 (754–1002) versus 875 (770–995) against serotype 2 (GMR 0·99 [0·82–1·20]); 599 (524–685) versus 610 (535–694) against serotype 3 (GMR 0·98 [0·82–1·18]); and 510 (453–575) versus 531 (470–601) against serotype 4 (GMR 0·96 [0·81–1·14]). At year 1, GMTs had decreased but remained above baseline for all serotypes: 504 (95% CI 403–630) in the two-dose group versus 490 (398–604) in the three-dose group against serotype 1 (GMR 1·03 [0·76–1·40]); 737 (611–888) versus 821 (704–957) against serotype 2 (GMR 0·90 [0·71–1·14]); 437 (368–519) versus 477 (405–561) against serotype 3 (GMR 0·92 [0·72–1·16]); and 238 (205–277) versus 270 (235–310) against serotype 4 (GMR 0·88 [0·72–1·09]). Reactogenicity profiles were similar across treatment groups. Most unsolicited adverse events after any injection were non-serious and systemic in nature. During the study, 60 serious adverse events were reported in 58 participants (14 in three-dose group, 26 in two-dose group, 18 in one-dose group), mostly infection and infestations or injury, poisoning, and procedural complications. No serious adverse events of special interest or admissions to hospital for dengue occurred. Two deaths occurred, unrelated to study treatment. Interpretation: A two-dose CYD-TDV regimen might be an alternative to the licensed three-dose regimen in individuals who are dengue seropositive at baseline and aged 9 years and older. Vaccination with a reduced number of doses could lead to improved vaccine compliance and coverage, especially in low-resource settings. Mención de responsabilidad : Diana Leticia Coronel-MartÍnez, Juliana Park, Eduardo López-Medina, María Rosario Capeding, Andrés Angelo Cadena Bonfanti, María Cecilia Montalbán, Isabel Ramírez, María Liza Antoinette Gonzales, Carlos A DiazGranados, Betzana Zambrano, Gustavo Dayan, Stephen Savarino, Zhenghong Chen, Hao Wang, Sunny Sun, Matthew Bonaparte, Andrey Rojas, Jenny Carolina Ramírez, Mae Ann Verdan, Fernando Noriega Referencia : Lancet Infect Dis. 2021 Apr;21(4):517-528. DOI (Digital Object Identifier) : 10.1016/S1473-3099(20)30767-2 PMID : 33212067 En línea : https://linkinghub.elsevier.com/retrieve/pii/S1473309920307672 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=5161 Immunogenicity and safety of simplified vaccination schedules for the CYD-TDV dengue vaccine in healthy individuals aged 9-50 years (CYD65): a randomised, controlled, phase 2, non-inferiority study. [documento electrónico] / Isabel Cristina Ramírez Sánchez, . - 2021.
Obra : The Lancet Infectious Diseases
Idioma : Inglés (eng)
Resumen : Background: Three doses of the licensed tetravalent dengue vaccine CYD-TDV (Dengvaxia, Sanofi Pasteur, Lyon France) are immunogenic and effective against symptomatic dengue in individuals aged 9 years and older who are dengue seropositive. Previous trials have provided some evidence that antibody responses elicited after just one dose or two doses of CYD-TDV might be similar to those elicited after three doses. We compared antibody responses following one-dose, two-dose, and three-dose vaccination regimens in individuals who were dengue seropositive at baseline up to 1 year after the last injection. Methods: In this randomised, controlled, phase 2, non-inferiority study (CYD65), healthy individuals aged 9–50 years were recruited from the community in three sites in Colombia and three sites in the Philippines. Participants were randomly assigned (1:1:1), using a permuted block method with stratification by site and age group, to receive, at 6-month intervals (on day 0, month 6, and month 12), three doses of CYD-TDV (three-dose group), one dose of placebo (on day 0) and two doses of CYD-TDV (at months 6 and 12; two-dose group), or two doses of placebo (on day 0 and month 6) and one dose of CYD-TDV (at month 12; one-dose group). Each dose of CYD-TDV was 0·5 mL, administered subcutaneously into the deltoid of the upper arm. Participants, study staff, investigators, and the funder were masked to group assignment. The co-primary endpoints were geometric mean titres (GMTs) of neutralising antibodies against each dengue virus serotype at 28 days and 1 year after the last vaccine injection. After a protocol amendment during the conduct of the study, the original co-primary objectives of non-inferiority of the one-dose and two-dose groups to the three-dose group were altered to include non-inferiority of the two-dose group to the three-dose group only, to be assessed in individuals who were dengue seropositive at baseline. Non-inferiority was shown if the lower limit of the 95% CI for the ratio of GMTs (GMR) at 28 days and 1 year between groups was more than 0·5 for each serotype. The analysis of the coprimary objectives was done in the per-protocol analysis dataset, which included all participants who had been vaccinated, had no protocol deviations, and had a valid serology test result for at least one dengue serotype at 28 days after the third injection. Safety was assessed throughout in all participants who received at least one injection of study drug, regardless of serostatus. This trial is registered with ClinicalTrials.gov, NCT02628444, and is closed to accrual. Findings: Between May 2, 2016, and Sept 16, 2016, we recruited and enrolled 1050 individuals, of whom 1048 received at least one injection and 993 had at least one blood sample taken (full-analysis dataset; 333 in three-dose group, 328 in two-dose group, and 332 in one-dose group). 860 (86·6%) of 993 participants in the full-analysis dataset were dengue seropositive at baseline. Non-inferiority (two dose vs three dose) was shown for each serotype at both 28 days and 1 year among dengue-seropositive participants (number of participants assessed: 272 [two-dose group], 265 [three-dose group] at 28 days; and 190 [two-dose group], 185 [three-dose group] at 1 year). At 28 days after the last injection, neutralising antibody GMTs were 899 (95% CI 752–1075) in the two-dose group versus 822 (700–964) in the three dose group against dengue serotype 1 (GMR 1·09 [95% CI 0·86–1·39]); 869 (754–1002) versus 875 (770–995) against serotype 2 (GMR 0·99 [0·82–1·20]); 599 (524–685) versus 610 (535–694) against serotype 3 (GMR 0·98 [0·82–1·18]); and 510 (453–575) versus 531 (470–601) against serotype 4 (GMR 0·96 [0·81–1·14]). At year 1, GMTs had decreased but remained above baseline for all serotypes: 504 (95% CI 403–630) in the two-dose group versus 490 (398–604) in the three-dose group against serotype 1 (GMR 1·03 [0·76–1·40]); 737 (611–888) versus 821 (704–957) against serotype 2 (GMR 0·90 [0·71–1·14]); 437 (368–519) versus 477 (405–561) against serotype 3 (GMR 0·92 [0·72–1·16]); and 238 (205–277) versus 270 (235–310) against serotype 4 (GMR 0·88 [0·72–1·09]). Reactogenicity profiles were similar across treatment groups. Most unsolicited adverse events after any injection were non-serious and systemic in nature. During the study, 60 serious adverse events were reported in 58 participants (14 in three-dose group, 26 in two-dose group, 18 in one-dose group), mostly infection and infestations or injury, poisoning, and procedural complications. No serious adverse events of special interest or admissions to hospital for dengue occurred. Two deaths occurred, unrelated to study treatment. Interpretation: A two-dose CYD-TDV regimen might be an alternative to the licensed three-dose regimen in individuals who are dengue seropositive at baseline and aged 9 years and older. Vaccination with a reduced number of doses could lead to improved vaccine compliance and coverage, especially in low-resource settings. Mención de responsabilidad : Diana Leticia Coronel-MartÍnez, Juliana Park, Eduardo López-Medina, María Rosario Capeding, Andrés Angelo Cadena Bonfanti, María Cecilia Montalbán, Isabel Ramírez, María Liza Antoinette Gonzales, Carlos A DiazGranados, Betzana Zambrano, Gustavo Dayan, Stephen Savarino, Zhenghong Chen, Hao Wang, Sunny Sun, Matthew Bonaparte, Andrey Rojas, Jenny Carolina Ramírez, Mae Ann Verdan, Fernando Noriega Referencia : Lancet Infect Dis. 2021 Apr;21(4):517-528. DOI (Digital Object Identifier) : 10.1016/S1473-3099(20)30767-2 PMID : 33212067 En línea : https://linkinghub.elsevier.com/retrieve/pii/S1473309920307672 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=5161 Reserva
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