TY - JOUR
T1 - Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions
AU - Villa, Luisa L.
AU - Perez, Gonzalo
AU - Kjaer, Susanne K.
AU - Paavonen, Jorma
AU - Lehtinen, Matti
AU - Muñoz, Nubia
AU - Sigurdsson, Kristján
AU - Hernandez-Avila, Mauricio
AU - Skjeldestad, Finn Egil
AU - Thoresen, Steinar
AU - García, Patricia
AU - Majewski, Slawomir
AU - Dillner, Joakim
AU - Olsson, Sven Eric
AU - Eng, Hseon Tay
AU - Bosch, F. Xavier
AU - Ault, Kevin A.
AU - Brown, Darron R.
AU - Ferris, Daron G.
AU - Koutsky, Laura A.
AU - Kurman, Robert J.
AU - Myers, Evan R.
AU - Barr, Eliav
AU - Boslego, John
AU - Bryan, Janine
AU - Esser, Mark T.
AU - Gause, Christine K.
AU - Hesley, Teresa M.
AU - Lupinacci, Lisa C.
AU - Sings, Heather L.
AU - Taddeo, Frank J.
AU - Thornton, Annemarie R.
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.
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.
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U2 - 10.1056/NEJMoa061741
DO - 10.1056/NEJMoa061741
M3 - Article
C2 - 17494925
AN - SCOPUS:34248326338
SN - 0028-4793
VL - 356
SP - 1915
EP - 1927
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 19
ER -