Intussusception and Rotavirus Vaccines: What Is the Background Risk?

Sáez-Llorens, Xavier; Guevara, Javier Nieto

doi:10.1097/00006454-200404000-00020

Cited by 20 publications

(10 citation statements)

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“…In a 5-year retrospective study in Panama (study period: 1998–2002), annual rates of 19 to 40 cases of IS per 100,000 children under 1 year of age, and 8 to 15 per 100,000 in children under 3 years of age were reported depending on the year of the study [29]. A study in Chile estimated the annual IS rates in children under 1 year and under 2 years of age to be 47–55 per 100,000 and 32–35 per 100,000, respectively [30].…”

Section: Discussionmentioning

confidence: 99%

A multi-country study of intussusception in children under 2 years of age in Latin America: analysis of prospective surveillance data

Sáez-Llorens

Velázquez

López³

et al. 2013

BMC Gastroenterol

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BackgroundIntussusception (IS) is a form of acute intestinal obstruction that occurs mainly in infants and is usually of unknown cause. An association between IS and the first licensed rotavirus vaccine, a reassortant-tetravalent, rhesus-based rotavirus vaccine (RRV-TV), led to the withdrawal of the vaccine. New rotavirus vaccines have now been developed and extensively studied for their potential association with IS. This study aimed to describe the epidemiology and to estimate the incidence of IS in Latin American infants prior to new vaccine introduction.MethodsChildren under 2 years of age representing potential IS cases were enrolled in 16 centers in 11 Latin American countries from January 2003 to May 2005. IS cases were classified as definite, probable, possible or suspected as stated on the Brighton Collaboration Working Group guidelines.ResultsFrom 517 potential cases identified, 476 (92%) cases were classified as definite, 21 probable, 10 possible and 10 suspected for intussusception. Among the 476 definite IS cases, the median age at presentation was 6.4 months with 89% of cases aged <1 year. The male to female ratio was 1.5:1. The incidence of definite IS per 100,000 subject-years ranged from 1.9 in Brazil to 62.4 in Argentina for children <2 years of age, and from 3.8 in Brazil to 105.3 in Argentina for children aged <1 year. Median hospital stay was 4 days with a high prevalence of surgery as the primary treatment (65%). Most cases (88%) made a complete recovery, but 13 (3%) died. No clear seasonal pattern of IS cases emerged.ConclusionsThis study describes the epidemiology and estimates the incidence of IS in Latin American infants prior to the introduction of new rotavirus vaccines. The incidence of IS was found to vary between different countries, as observed in previous studies.Trial registrationClinical study identifier 999910/204 (SERO-EPI-IS-204)

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Section: Discussionmentioning

confidence: 99%

A multi-country study of intussusception in children under 2 years of age in Latin America: analysis of prospective surveillance data

Sáez-Llorens

Velázquez

López³

et al. 2013

BMC Gastroenterol

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“…Esto pudo deberse al elevado inóculo viral y a la predisposición de algunos niños a esta complicación después de la exposición a ciertas cepas (6, 7). La incidencia de la invaginación intestinal puede variar entre 18 y 89 casos por 100 000 niños menores de 1 año (8).…”

Section: Forma De Citarunclassified

“…Cuatro de ellas expresan las proteínas exteriores G1, G2, G3 y G4 de la cáp-side viral de los rotavirus parentales humanos correspondientes y la proteína de fijación VP7 del rotavirus parental bovino. El quinto virus reagrupado expresa la proteína de fusión P1AP [8] del rotavirus parental humano y la proteína G6 de la cápside viral del rotavirus parental bovino. Según los resultados de los estudios clínicos, la vacuna oral Rotateq ® ha mostrado una buena tolerancia y provee una adecuada protección contra la enfermedad por rotavirus, ya que induce la producción de anticuerpos neutralizantes de los serotipos humanos más frecuentes (9).…”

Section: Forma De Citarunclassified

“…La segunda vacuna aprobada, Rotarix ® (GlaxoSmithKline Biologicals, Bél-gica), es una vacuna oral monovalente de virus vivo atenuado con una cepa G1P [8] que expresa las proteínas VP4 y VP7 de la mayoría de los serotipos de rotavirus humanos. En el ensayo multicéntrico Rota-023 se evaluó la eficacia de esta vacuna en una muestra de 63 225 infantes de 2 a 4 meses de edad de 11 países latinoamericanos y Finlandia (10).…”

Section: Forma De Citarunclassified

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Impacto de la introducción de la vacuna contra el rotavirus en la hospitalización por gastroenteritis aguda grave en el Hospital del Niño de la Ciudad de Panamá

Guevara¹,

López²,

González³

2008

Rev Panam Salud Publica

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Impacto de la introducción de la vacuna contra el rotavirus en la hospitalización por gastroenteritis aguda grave en el Hospital del Niño de la Ciudad de Panamá Javier Nieto Guevara, 1 Óscar López 1 y Gala González 1 (RR = 1,12; IC95%: 0,87 a 1,44; P = 0,39) Objetivos. Determinar si la introducción de la vacunación infantil contra el rotavirus en . No se encontraron diferencias significativas en relación al tiempo de hospitalización por grupos de edad en los periodos analizados. La proporción de casos tratados con antibióticos fue similar en ambos períodos de estudio (29,7% contra 25,2%; P = 0,08). Conclusiones. No se encontró que la introducción de la vacunación infantil contra el rotavirus en Panamá llevara a una reducción significativa en la tasa de hospitalización por gastroenteritis en niños menores de 5 años. No se observaron cambios significativos en la morbimortalidad y el uso de antibióticos en el tratamiento de la gastroenteritis aguda grave después de la introducción de la vacuna.Vacuna contra rotavirus, diarrea infantil, Panamá. RESUMENCada año, el rotavirus causa 111 millones de casos de gastroenteritis que requieren cuidados en casa, 25 millones de visitas médicas, 2 millones de hospitalizaciones y entre 352 000 y 592 000 muertes, de ellas alrededor de 440 000 en niños menores de 5 años de edad (1). La infección por rotavirus es la segunda causa de muerte en el mundo en este grupo de edad, solo su- Palabras clave Investigación original / Original researchNieto Guevara J, López O, González G. Impacto de la introducción de la vacuna contra el rotavirus en la hospitalización por gastroenteritis aguda grave en el Hospital del Niño de la Ciudad de Panamá. Rev Panam Salud Publica. 2008;24(3):189-94.

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“…To provide a clear epidemiological statement about IS following vaccination, the incidence of IS has to be determined prior to global introduction of these new vaccines in order to establish baseline disease incidence rates and allow for interpretation of post-licensure IS surveillance data [7]. …”

Section: Introductionmentioning

confidence: 99%

Hospital-based, prospective, multicentre surveillance to determine the incidence of intussusception in children aged below 15 years in Germany

et al. 2011

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BackgroundA new vaccine against Rotavirus (RV) gastroenteritis was introduced in Germany in 2006. In 1997 the first RV vaccine was withdrawn due to an increased incidence in intussusception (IS). Thus, an accurate estimation of the incidence of IS is important for post-licensure surveillance.MethodsIS-Data were obtained from the 'Erhebungseinheit für seltene pädiatrische Erkrankungen Deutschland' (ESPED, German surveillance unit for rare pediatric diseases) collaborations' central register where all cases of intussusception in Germany for the years 2006 and 2007 are collected (n = 1200). In order to obtain an unbiased estimate of the incidence, it is necessary to determine the population under risk out of which these cases originated, and the proportion of real cases not reported to the registry (underreporting). In order to assess underreporting, a random sample of 31 hospitals was re-assessed by an outside reviewer. The estimation of incidence was done using a single Maximum-Likelihood (ML) estimator based on data from both the registry and the sample.ResultsThe uncorrected observed incidence was calculated to be 26.6/100,000 child-years for children below 1 year old, 23.8 for those below 2 years old, and 5.2 for those below 15 years old. The review revealed a mean reporting quota of about 41% and the ML approach yielded an incidence of 51.5/100,000 child-years (95%CI [41.7;61.1]) for children below 2 years of age.ConclusionsWhile substantial under-reporting led to very conservative estimates of the IS incidence, the approach described here allows an accurate estimation of IS incidence including corresponding confidence bands. Therefore, ML estimation is a straightforward instrument to derive stable, unbiased estimates in epidemiological studies with incomplete data.

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Intussusception and Rotavirus Vaccines: What Is the Background Risk?

Cited by 20 publications

References 6 publications

A multi-country study of intussusception in children under 2 years of age in Latin America: analysis of prospective surveillance data

A multi-country study of intussusception in children under 2 years of age in Latin America: analysis of prospective surveillance data

Impacto de la introducción de la vacuna contra el rotavirus en la hospitalización por gastroenteritis aguda grave en el Hospital del Niño de la Ciudad de Panamá

Hospital-based, prospective, multicentre surveillance to determine the incidence of intussusception in children aged below 15 years in Germany

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