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

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...

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Autor Principal: Ruiz Sternberg, Angela Maria
Formato: Artículo (Article)
Lenguaje:Inglés (English)
Publicado: Massachusetts Medical Society 2007
Materias:
Acceso en línea:https://repository.urosario.edu.co/handle/10336/26826
https://doi.org/10.1056/NEJMoa061741
id ir-10336-26826
recordtype dspace
spelling ir-10336-268262020-08-19T14:40:19Z Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions Vacuna cuadrivalente contra el virus del papiloma humano para prevenir lesiones cervicales de alto grado Ruiz Sternberg, Angela Maria Hematology Oncology gynecologic Oncology dermatology Vaccines genetics 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. opens in new tab.) 2007-05-10 2020-08-19T14:40:19Z info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion ISSN: 0028-4793 EISSN: 1533-4406 https://repository.urosario.edu.co/handle/10336/26826 https://doi.org/10.1056/NEJMoa061741 eng info:eu-repo/semantics/openAccess application/pdf Massachusetts Medical Society The New England Journal of Medicine
institution EdocUR - Universidad del Rosario
collection DSpace
language Inglés (English)
topic Hematology
Oncology gynecologic
Oncology dermatology
Vaccines genetics
spellingShingle Hematology
Oncology gynecologic
Oncology dermatology
Vaccines genetics
Ruiz Sternberg, Angela Maria
Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions
description 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. opens in new tab.)
format Artículo (Article)
author Ruiz Sternberg, Angela Maria
author_facet Ruiz Sternberg, Angela Maria
author_sort Ruiz Sternberg, Angela Maria
title Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions
title_short Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions
title_full Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions
title_fullStr Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions
title_full_unstemmed Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions
title_sort quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions
publisher Massachusetts Medical Society
publishDate 2007
url https://repository.urosario.edu.co/handle/10336/26826
https://doi.org/10.1056/NEJMoa061741
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