TY - JOUR
T1 - The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in sexually active women aged 16-26 years
AU - Wheeler, Cosette M
AU - Kjaer, Susanne K
AU - Sigurdsson, Kristján
AU - Iversen, Ole-Erik
AU - Hernandez-Avila, Mauricio
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 - Steben, Marc
AU - Bosch, F Xavier
AU - Dillner, Joakim
AU - Joura, Elmar A
AU - Kurman, Robert J
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 - Lupinacci, Lisa C
AU - Giacoletti, Katherine E D
AU - James, Margaret
AU - Vuocolo, Scott
AU - Hesley, Teresa M
AU - Barr, Eliav
PY - 2009/4/1
Y1 - 2009/4/1
N2 - BACKGROUND: We evaluated the impact of a quadrivalent human papillomavirus (HPV) vaccine on infection and cervical disease related to 10 nonvaccine HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, and 59) associated with >20% of cervical cancers. The population evaluated included HPV-naive women and women with preexisting HPV infection and/or HPV-related disease at enrollment.METHODS: Phase 3 efficacy studies enrolled 17,622 women aged 16-26 years. Subjects underwent cervicovaginal sampling and Pap testing on day 1 and then at 6-12-month intervals for up to 4 years. HPV typing was performed on samples from enrollment and follow-up visits, including samples obtained for diagnosis or treatment of HPV-related disease. All subjects who received 1 dose and returned for follow-up were included.RESULTS: Vaccination reduced the rate of HPV-31/33/45/52/58 infection by 17.7% (95% confidence interval [CI], 5.1% to 28.7%) and of cervical intraepithelial neoplasia (CIN) 1-3 or adenocarcinoma in situ (AIS) by 18.8% (95% CI, 7.4% to 28.9%). Vaccination also reduced the rate of HPV-31/58/59-related CIN1-3/AIS by 26.0% (95% CI, 6.7% to 41.4%), 28.1% (95% CI, 5.3% to 45.6%), and 37.6% (95% CI, 6.0% to 59.1%), respectively. Although a modest reduction in HPV-31/33/45/52/58-related CIN2 or worse was observed, the estimated reduction was not statistically significant.CONCLUSIONS: These cross-protection results complement the vaccine's prophylactic efficacy against disease associated with HPV-6, -11, -16, and -18. Long-term monitoring of vaccinated populations are needed to fully ascertain the population-based impact and public health significance of these findings.TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT00092521 , NCT00092534 , and NCT00092482.
AB - BACKGROUND: We evaluated the impact of a quadrivalent human papillomavirus (HPV) vaccine on infection and cervical disease related to 10 nonvaccine HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, and 59) associated with >20% of cervical cancers. The population evaluated included HPV-naive women and women with preexisting HPV infection and/or HPV-related disease at enrollment.METHODS: Phase 3 efficacy studies enrolled 17,622 women aged 16-26 years. Subjects underwent cervicovaginal sampling and Pap testing on day 1 and then at 6-12-month intervals for up to 4 years. HPV typing was performed on samples from enrollment and follow-up visits, including samples obtained for diagnosis or treatment of HPV-related disease. All subjects who received 1 dose and returned for follow-up were included.RESULTS: Vaccination reduced the rate of HPV-31/33/45/52/58 infection by 17.7% (95% confidence interval [CI], 5.1% to 28.7%) and of cervical intraepithelial neoplasia (CIN) 1-3 or adenocarcinoma in situ (AIS) by 18.8% (95% CI, 7.4% to 28.9%). Vaccination also reduced the rate of HPV-31/58/59-related CIN1-3/AIS by 26.0% (95% CI, 6.7% to 41.4%), 28.1% (95% CI, 5.3% to 45.6%), and 37.6% (95% CI, 6.0% to 59.1%), respectively. Although a modest reduction in HPV-31/33/45/52/58-related CIN2 or worse was observed, the estimated reduction was not statistically significant.CONCLUSIONS: These cross-protection results complement the vaccine's prophylactic efficacy against disease associated with HPV-6, -11, -16, and -18. Long-term monitoring of vaccinated populations are needed to fully ascertain the population-based impact and public health significance of these findings.TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT00092521 , NCT00092534 , and NCT00092482.
KW - Adenocarcinoma/prevention & control
KW - Adolescent
KW - Adult
KW - Alphapapillomavirus/classification
KW - Female
KW - Humans
KW - Papillomavirus Infections/prevention & control
KW - Papillomavirus Vaccines
KW - Uterine Cervical Neoplasms/prevention & control
KW - Young Adult
KW - Uterine Cervical Dysplasia/prevention & control
U2 - 10.1086/597309
DO - 10.1086/597309
M3 - Journal article
C2 - 19236277
SN - 0022-1899
VL - 199
SP - 936
EP - 944
JO - The Journal of infectious diseases
JF - The Journal of infectious diseases
IS - 7
ER -