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Title: Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions
Authors: The Future II Study Group*
Moreira Júnior, Edson Duarte
Affilliation: Females United to Unilaterally Disease Reduce Endo/Ectocervical Disease
Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
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. ( number, NCT00092534 [
DeCS: lphapapillomavirus
Neoplasia Intraepitelial Cervical/prevenção & controle
Infecções por Papillomavirus/prevenção & controle
Vacinas contra Papillomavirus
Neoplasias do Colo do Útero/prevenção & controle
Neoplasia Intraepitelial Cervical/epidemiologia
DNA Viral/sangue
Método Duplo-Cego
Papillomavirus Humano 16/genética
Papillomavirus Humano 18/isolamento & purificação
Vacinas contra Papillomavirus/efeitos adversos
Fatores de Tempo
Neoplasias do Colo do Útero/epidemiologia
Issue Date: 2007
Publisher: Massachusetts Medical Society
Citation: The FUTURE II Study Group; MOREIRA Júnior, E.D. et al. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. New England Journal of Medicine, v. 356, n. 19, p. 1915-1927, 2007.
ISSN: 1533-4406
Copyright: open access
Appears in Collections:BA - IGM - Artigos de Periódicos

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