Impact of Human Papillomavirus (HPV)-6/11/16/18 Vaccine on All HPV-Associated Genital Diseases in Young Women

Background The impact of the prophylactic vaccine against human papillomavirus (HPV) types 6, 11, 16, and 18 (HPV6/11/16/18) on all HPV-associated genital disease was investigated in a population that approximates sexually naive women in that they were 'negative to 14 HPV types' and in a mixed population of HPV-exposed and-unexposed women (intention-to-treat group).MethodsThis analysis studied 17 622 women aged 15-26 years who were enrolled in one of two randomized, placebo-controlled, efficacy trials for the HPV6/11/16/18 vaccine (first patient on December 28, 2001, and studies completed July 31, 2007). Vaccine or placebo was given at day 1, month 2, and month 6. All women underwent cervicovaginal sampling and Papanicolaou (Pap) testing at day 1 and every 6-12 months thereafter. Outcomes were any cervical intraepithelial neoplasia; any external anogenital and vaginal lesions; Pap test abnormalities; and procedures such as colposcopy and definitive therapy. Absolute rates are expressed as women with endpoint per 100 person-years at risk.ResultsThe average follow-up was 3.6 years (maximum of 4.9 years). In the population that was negative to 14 HPV types, vaccination was up to 100% effective in reducing the risk of HPV16/18-related high-grade cervical, vulvar, and vaginal lesions and of HPV6/11-related genital warts. In the intention-to-treat group, vaccination also statistically significantly reduced the risk of any high-grade cervical lesions (19.0% reduction; rate vaccine = 1.43, rate placebo = 1.76, difference = 0.33, 95% confidence interval [CI] = 0.13 to 0.54), vulvar and vaginal lesions (50.7% reduction; rate vaccine = 0.10, rate placebo = 0.20, difference = 0.10, 95% CI = 0.04 to 0.16), genital warts (62.0% reduction; rate vaccine = 0.44, rate placebo = 1.17, difference = 0.72, 95% CI = 0.58 to 0.87), Pap abnormalities (11.3% reduction; rate vaccine = 10.36, rate placebo = 11.68, difference = 1.32, 95% CI = 0.74 to 1.90), and cervical definitive therapy (23.0% reduction; rate vaccine = 1.97, rate placebo = 2.56, difference = 0.59, 95% CI = 0.35 to 0.83), irrespective of causal HPV type.ConclusionsHigh-coverage HPV vaccination programs among adolescents and young women may result in a rapid reduction of genital warts, cervical cytological abnormalities, and diagnostic and therapeutic procedures. In the longer term, substantial reductions in the rates of cervical, vulvar, and vaginal cancers may follow.

• Fecha de publicación: 2010
• Institución: Universidad del Rosario
• Repositorio: Repositorio EdocUR - U. Rosario
• Idioma: eng
• OAI Identifier: oai:repository.urosario.edu.co:10336/22479
• Acceso en línea: https://doi.org/10.1093/jnci/djp534; https://repository.urosario.edu.co/handle/10336/22479
• Palabra clave: Aluminum hydroxyphosphate sulfate; Immunological adjuvant; Placebo; Silgard; Unclassified drug; Wart virus vaccine; Adenocarcinoma in situ; Adjuvant therapy; Adolescent; Adult; Article; Carcinoma in situ; Clinical trial; Colposcopy; Condyloma acuminatum; Controlled clinical trial; Controlled study; Double blind procedure; Drug efficacy; Female; Follow up; Gynecologic disease; Human; Human papillomavirus type 11; Human papillomavirus type 16; Human papillomavirus type 18; Human papillomavirus type 6; Human tissue; Major clinical study; Multicenter study; Papanicolaou test; Population exposure; Priority journal; Randomized controlled trial; Risk reduction; Uterine cervix carcinoma in situ; Uterine cervix cytology; Vaccination; Vagina cancer; Vagina intraepithelial neoplasia; Vulva cancer; Vulva intraepithelial neoplasia; Adolescent; Adult; Alphapapillomavirus; Cervical intraepithelial neoplasia; Female; Human papillomavirus 11; Human papillomavirus 16; Human papillomavirus 18; Human papillomavirus 6; Humans; Kaplan-meiers estimate; Papillomavirus infections; Papillomavirus vaccines; Sexual partners; Sexually transmitted diseases; Tumor virus infections; Uterine cervical neoplasms; Vaginal smears; World health; Young adult; female; Genital diseases
• License: Abierto (Texto Completo)