Ítem
Solo Metadatos
A pooled analysis of continued prophylactic efficacy of quadrivalent human papillomavirus (types 6/11/16/18) vaccine against high-grade cervical and external genital lesions
Título de la revista
Autores
Kjaer, Susanne K.
Sigurdsson, Kristján
Iversen, Ole-Erik
Hernandez-Avila, Mauricio
Wheeler, Cosette M.
Perez, Gonzalo
Brown, Darron R.
Koutsky, Laura A.
Tay, Eng Hseon
García, Patricia
Resumen
Abstract
Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/11/16/18-related cervical, vaginal, and vulvar disease through 3 years. We provide an update on the efficacy of the quadrivalent HPV vaccine against high-grade cervical, vaginal, and vulvar lesions based on end-of-study data from three clinical trials. Additionally, we stratify vaccine efficacy by several baseline characteristics, including age, smoking status, and Papanicolaou (Pap) test results. A total of 18,174 females ages 16 to 26 years were randomized and allocated into one of three clinical trials (protocols 007, 013, and 015). Vaccine or placebo was given at baseline, month 2, and month 6. Pap testing was conducted at regular intervals. Cervical and anogenital swabs were collected for HPV DNA testing. Examination for the presence of vulvar and vaginal lesions was also done. Endpoints included high-grade cervical, vulvar, or vaginal lesions (CIN 2/3, VIN 2/3, or ValN 2/3). Mean follow-up time was 42 months post dose 1. Vaccine efficacy against HPV 6/11/16/18-related high-grade cervical lesions in the per-protocol and intention-to-treat populations was 98.2% [95% confidence interval (95% CI), 93.3-99.8] and 51.5% (95% CI, 40.6-60.6), respectively. Vaccine efficacy against HPV 6/11/16/18-related high-grade vulvar and vaginal lesions in the per-protocol and intention-to-treat populations was 100.0% (95% CI, 82.6-100.0) and 79.0% (95% CI, 56.4-91.0), respectively. Efficacy in the intention-to-treat population tended to be lower in older women, women with more partners, and women with abnormal Pap test results. The efficacy of quadrivalent HPV vaccine against high-grade cervical and external anogenital neoplasia remains high through 42 months post vaccination. ©2009 American Association for Cancer Research.
Palabras clave
Keywords
Virus DNA , Female , Adolescent , Adult , Age distribution , Article , Cancer immunization , Cancer prevention , Clinical trial , Controlled clinical trial , Controlled study , Drug efficacy , Drug withdrawal , Female , Follow up , Human , Human papillomavirus type 11 , Human papillomavirus type 16 , Human papillomavirus type 18 , Human papillomavirus type 6 , Major clinical study , Multicenter study , Papanicolaou test , Phase 3 clinical trial , Priority journal , Randomized controlled trial , Sexual behavior , Smoking , Unspecified side effect , Uterine cervix cancer , Vagina cancer , Virus detection , Vulva cancer , Adolescent , Adult , Cancer Vaccines , Cervical Intraepithelial Neoplasia , Clinical Trials , Female , Genital Diseases , Human papillomavirus 11 , Human papillomavirus 16 , Human papillomavirus 18 , Human papillomavirus 6 , Humans , Multicenter Studies as Topic , Papillomavirus Infections , Papillomavirus Vaccines , Randomized Controlled Trials as Topic , Uterine Cervical Neoplasms , Young Adult
