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 - Mauricio, Hernandez Avila
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 Gale
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 - Barra, Eliav
N1 - Funding Information:
Potential conflicts of interest. N.M. has received lecture fees, advisory board fees, and consultancy fees from Merck and Sanofi Pasteur MSD. S.-E.O. has received lecture fees from Merck. M.H.-A. has received lecture fees and grant support from Merck. O.-E.I. has received lecture fees from Merck and Glaxo-SmithKline (GSK). C.M.W. has received funding through her institution to conduct HPV vaccine studies for GSK. K.A.A. has received consultancy and advisory board fees from Merck and has received funding through his institution to conduct HPV vaccine studies for Merck and GSK and nonvaccine clinical trials for Gen-Probe. F.X.B. has received lecture fees from Merck and GSK and has received funding through his institution to conduct HPV vaccine studies for GSK. J.P. has received consultancy fees, advisory board fees, and lecture fees from Merck. J.D. has received consultancy fees, lecture fees, and research grants from Merck and Sanofi Pasteur MSD. S.L. has received lecture fees from Merck and Sanofi Pasteur MSD. E.A.J. has received lecture fees from Merck, Sanofi Pasteur MSD, and GSK. S.K.K. has received consultancy fees and funding through her institution to conduct HPV vaccine studies for Sanofi Pasteur MSD and Di-gene. S.M.G. has received advisory board fees and grant support from Commonwealth Serum Laboratories and GSK and lecture fees from Merck. D.G.F. has received consultancy fees and funding through his institution to conduct HPV vaccine studies for GSK and has received lecture fees and consultancy fees from Merck. K.S. has received consultancy fees from Merck. S.M. has received lecture fees and advisory board fees from Merck. G.P. has received lecture fees and consultancy fees from Merck and Sanofi Pasteur MSD. D.R.B. has received lecture fees, advisory board fees, and intellectual property fees from Merck. M.S. has received lecture fees and grant support from Merck. Additionally, S.-E.O., C.M.W., M.H.-A., L.L.V., O.-E.I., G.W.K.T., F.X.B., J.P., J.D., E.H.T., S.L., E.A.J., S.K.K., G.P., D.G.F., K.S., M.S., L.A.K., and D.R.B. have received funding through their institutions to conduct HPV vaccine studies for Merck. F.J.T., C.R., A.T., J.B., L.C.L., K.E.D.G., S.V., M.J., T.M.H., and E.B. are employees of Merck and potentially own stock and/or stock options in the company.
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.
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U2 - 10.1086/597309
DO - 10.1086/597309
M3 - Article
C2 - 19236277
AN - SCOPUS:65549116473
SN - 0022-1899
VL - 199
SP - 936
EP - 944
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 7
ER -