Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions

FUTURE II Study Group

doi:10.1056/NEJMoa061741

Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions

Título traducido de la contribución: Vacuna tetravalente contra el virus del papiloma humano para prevenir las lesiones cervicales de alto grado

FUTURE II Study Group

Producción científica: Contribución a revista › Artículo de Investigación › revisión exhaustiva

1914 Citas (Scopus)

Resumen

ANTECEDENTES: Los tipos 16 (VPH-16) y 18 (VPH-18) del virus del papiloma humano causan aproximadamente el 70% de los cánceres de cuello uterino en todo el mundo. Se llevó a cabo un ensayo de fase 3 para evaluar una vacuna tetravalente contra los tipos 6, 11, 16 y 18 del VPH (VPH-6/11/16/18) para la prevención de las lesiones cervicales de alto grado asociadas con el VPH-16 y el VPH-18.

MÉTODOS: En este ensayo aleatorizado, doble ciego, se asignó a 12.167 mujeres de entre 15 y 26 años de edad a recibir tres dosis de la vacuna HPV-6/11/16/18 o placebo, administradas en el día 1, el mes 2 y el mes 6. El análisis primario se realizó para una población susceptible por protocolo que incluía a 5.305 mujeres en el grupo de la vacuna y 5.260 en el grupo placebo que no tenían evidencia virológica de infección por VPH-16 o VPH-18 hasta 1 mes después de la tercera dosis (mes 7). El criterio de valoración compuesto primario fue la neoplasia intraepitelial cervical de grado 2 o 3, el adenocarcinoma in situ o el cáncer cervical relacionado con el VPH-16 o el VPH-18.

RESULTADOS: Se realizó un seguimiento de los sujetos durante una media de 3 años tras recibir la primera dosis de vacuna o placebo. La eficacia de la vacuna para la prevención del objetivo primario compuesto fue del 98% (intervalo de confianza [IC] del 95,89%, 86 a 100) en la población susceptible por protocolo y del 44% (IC del 95%, 26 a 58) en una población por intención de tratar de todas las mujeres que habían sido aleatorizadas (con o sin infección previa). La eficacia estimada de la vacuna contra todas las lesiones cervicales de alto grado, independientemente del tipo de VPH causal, en esta población por intención de tratar fue del 17% (IC del 95%, 1 a 31).

CONCLUSIONES: En las mujeres jóvenes que no se habían infectado previamente por el VPH-16 o el VPH-18, las del grupo de la vacuna presentaron una incidencia significativamente menor de neoplasia intraepitelial cervical de alto grado relacionada con el VPH-16 o el VPH-18 que las del grupo placebo. (Número de ClinicalTrials.gov, NCT00092534 [ClinicalTrials.gov]).

Título traducido de la contribución	Vacuna tetravalente contra el virus del papiloma humano para prevenir las lesiones cervicales de alto grado
Idioma original	Inglés estadounidense
Páginas (desde-hasta)	1915-1927
Número de páginas	13
Publicación	New England Journal of Medicine
Volumen	356
N.º	19
DOI	https://doi.org/10.1056/NEJMoa061741
Estado	Publicada - may 10 2007

ODS de las Naciones Unidas

Este resultado contribuye a los siguientes Objetivos de Desarrollo Sostenible

ODS 3: Salud y bienestar

Áreas temáticas de ASJC Scopus

Enfermedades infecciosas
Epidemiología

Acceder al documento

10.1056/NEJMoa061741

Citar esto

@article{4292414e46cd4450b4c67931cdb177c6,

title = "Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions",

abstract = "BACKGROUND: Human papillomavirus types 16 (HPV-16) and 18 (HPV-18) cause approximately 70\% of cervical cancers worldwide. A phase 3 trial was conducted to evaluate a quadrivalent vaccine against HPV types 6, 11, 16, and 18 (HPV-6/11/16/18) for the prevention of high-grade cervical lesions associated with HPV-16 and HPV-18.METHODS: In this randomized, double-blind trial, we assigned 12,167 women between the ages of 15 and 26 years to receive three doses of either HPV-6/11/16/18 vaccine or placebo, administered at day 1, month 2, and month 6. The primary analysis was performed for a per-protocol susceptible population that included 5305 women in the vaccine group and 5260 in the placebo group who had no virologic evidence of infection with HPV-16 or HPV-18 through 1 month after the third dose (month 7). The primary composite end point was cervical intraepithelial neoplasia grade 2 or 3, adenocarcinoma in situ, or cervical cancer related to HPV-16 or HPV-18.RESULTS: Subjects were followed for an average of 3 years after receiving the first dose of vaccine or placebo. Vaccine efficacy for the prevention of the primary composite end point was 98\% (95.89\% confidence interval [CI], 86 to 100) in the per-protocol susceptible population and 44\% (95\% CI, 26 to 58) in an intention-to-treat population of all women who had undergone randomization (those with or without previous infection). The estimated vaccine efficacy against all high-grade cervical lesions, regardless of causal HPV type, in this intention-to-treat population was 17\% (95\% CI, 1 to 31).CONCLUSIONS: In young women who had not been previously infected with HPV-16 or HPV-18, those in the vaccine group had a significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than did those in the placebo group. (ClinicalTrials.gov number, NCT00092534 [ClinicalTrials.gov].).",

author = "\{FUTURE II Study Group\} and \{Angela Maria\}, Ruiz-Sternberg",

year = "2007",

month = may,

day = "10",

doi = "10.1056/NEJMoa061741",

language = "English (US)",

volume = "356",

pages = "1915--1927",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachussetts Medical Society",

number = "19",

}

TY - JOUR

T1 - Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions

AU - FUTURE II Study Group

AU - Angela Maria, Ruiz-Sternberg

PY - 2007/5/10

Y1 - 2007/5/10

N2 - BACKGROUND: Human papillomavirus types 16 (HPV-16) and 18 (HPV-18) cause approximately 70% of cervical cancers worldwide. A phase 3 trial was conducted to evaluate a quadrivalent vaccine against HPV types 6, 11, 16, and 18 (HPV-6/11/16/18) for the prevention of high-grade cervical lesions associated with HPV-16 and HPV-18.METHODS: In this randomized, double-blind trial, we assigned 12,167 women between the ages of 15 and 26 years to receive three doses of either HPV-6/11/16/18 vaccine or placebo, administered at day 1, month 2, and month 6. The primary analysis was performed for a per-protocol susceptible population that included 5305 women in the vaccine group and 5260 in the placebo group who had no virologic evidence of infection with HPV-16 or HPV-18 through 1 month after the third dose (month 7). The primary composite end point was cervical intraepithelial neoplasia grade 2 or 3, adenocarcinoma in situ, or cervical cancer related to HPV-16 or HPV-18.RESULTS: Subjects were followed for an average of 3 years after receiving the first dose of vaccine or placebo. Vaccine efficacy for the prevention of the primary composite end point was 98% (95.89% confidence interval [CI], 86 to 100) in the per-protocol susceptible population and 44% (95% CI, 26 to 58) in an intention-to-treat population of all women who had undergone randomization (those with or without previous infection). The estimated vaccine efficacy against all high-grade cervical lesions, regardless of causal HPV type, in this intention-to-treat population was 17% (95% CI, 1 to 31).CONCLUSIONS: In young women who had not been previously infected with HPV-16 or HPV-18, those in the vaccine group had a significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than did those in the placebo group. (ClinicalTrials.gov number, NCT00092534 [ClinicalTrials.gov].).

AB - BACKGROUND: Human papillomavirus types 16 (HPV-16) and 18 (HPV-18) cause approximately 70% of cervical cancers worldwide. A phase 3 trial was conducted to evaluate a quadrivalent vaccine against HPV types 6, 11, 16, and 18 (HPV-6/11/16/18) for the prevention of high-grade cervical lesions associated with HPV-16 and HPV-18.METHODS: In this randomized, double-blind trial, we assigned 12,167 women between the ages of 15 and 26 years to receive three doses of either HPV-6/11/16/18 vaccine or placebo, administered at day 1, month 2, and month 6. The primary analysis was performed for a per-protocol susceptible population that included 5305 women in the vaccine group and 5260 in the placebo group who had no virologic evidence of infection with HPV-16 or HPV-18 through 1 month after the third dose (month 7). The primary composite end point was cervical intraepithelial neoplasia grade 2 or 3, adenocarcinoma in situ, or cervical cancer related to HPV-16 or HPV-18.RESULTS: Subjects were followed for an average of 3 years after receiving the first dose of vaccine or placebo. Vaccine efficacy for the prevention of the primary composite end point was 98% (95.89% confidence interval [CI], 86 to 100) in the per-protocol susceptible population and 44% (95% CI, 26 to 58) in an intention-to-treat population of all women who had undergone randomization (those with or without previous infection). The estimated vaccine efficacy against all high-grade cervical lesions, regardless of causal HPV type, in this intention-to-treat population was 17% (95% CI, 1 to 31).CONCLUSIONS: In young women who had not been previously infected with HPV-16 or HPV-18, those in the vaccine group had a significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than did those in the placebo group. (ClinicalTrials.gov number, NCT00092534 [ClinicalTrials.gov].).

U2 - 10.1056/NEJMoa061741

DO - 10.1056/NEJMoa061741

M3 - Research Article

C2 - 17494925

SN - 0028-4793

VL - 356

SP - 1915

EP - 1927

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 19

ER -

Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions

Resumen

ODS de las Naciones Unidas

Áreas temáticas de ASJC Scopus

Acceder al documento

Huella

Citar esto