TY - JOUR

T1 - 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

AU - Kjaer, Susanne K

AU - Sigurdsson, Kristján

AU - Iversen, Ole-Erik

AU - Hernandez-Avila, Mauricio

AU - Wheeler, Cosette M

AU - Perez, Gonzalo

AU - Brown, Darron R

AU - Koutsky, Laura A

AU - Tay, Eng Hseon

AU - García, Patricia

AU - Ault, Kevin A

AU - Garland, Suzanne M

AU - Leodolter, Sepp

AU - Olsson, Sven-Eric

AU - Tang, Grace W K

AU - Ferris, Daron G

AU - Paavonen, Jorma

AU - Lehtinen, Matti

AU - Steben, Marc

AU - Bosch, F Xavier

AU - Dillner, Joakim

AU - Joura, Elmar A

AU - Majewski, Slawomir

AU - Muñoz, Nubia

AU - Myers, Evan R

AU - Villa, Luisa L

AU - Taddeo, Frank J

AU - Roberts, Christine

AU - Tadesse, Amha

AU - Bryan, Janine

AU - Maansson, Roger

AU - Lu, Shuang

AU - Vuocolo, Scott

AU - Hesley, Teresa M

AU - Saah, Alfred

AU - Barr, Eliav

AU - Haupt, Richard M

N1 - Keywords: Adolescent; Adult; Cancer Vaccines; Cervical Intraepithelial Neoplasia; Clinical Trials, Phase III as Topic; Female; Genital Diseases, Female; 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

PY - 2009

Y1 - 2009

N2 - 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 VaIN 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.

AB - 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 VaIN 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.

U2 - 10.1158/1940-6207.CAPR-09-0031

DO - 10.1158/1940-6207.CAPR-09-0031

M3 - Journal article

C2 - 19789295

VL - 2

SP - 868

EP - 878

JO - Cancer Prevention Research

JF - Cancer Prevention Research

SN - 1940-6207

IS - 10

ER -