Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in women aged 15-25 years with and without serological evidence of previous exposure to HPV-16/18.

作者: A. Szarewski , W.A.J. Poppe , S.R. Skinner , C.M. Wheeler , J. Paavonen

DOI: 10.1002/IJC.26362

关键词:

摘要: In the Phase III PATRICIA study (NCT00122681), human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (Cervarix(®), GlaxoSmithKline Biologicals) was highly efficacious against HPV-16/18 infections and precancerous lesions in women deoxyribose nucleic acid (DNA) negative seronegative at baseline. We present further data on efficacy (VE) total vaccinated cohort including who may have been exposed to infection before vaccination. with no evidence of current or previous (DNA seronegative), VE 90.3% (96.1% confidence interval: 87.3-92.6) 6-month persistent (PI), 91.9% (84.6-96.2) cervical intraepithelial neoplasia (CIN)1+ 94.6% (86.3-98.4) CIN2+ [97.7% (91.1-99.8) when using HPV type assignment algorithm (TAA)]. DNA but serological (seropositive), 72.3% (53.0-84.5) PI, 67.2% (10.9-89.9) CIN1+, 68.8% (-28.3-95.0) [88.5% (10.8-99.8) TAA]. negative), regardless their baseline status, 88.7% (85.7-91.1) 89.1% (81.6-94.0) CIN1+ 92.4% (84.0-97.0) [97.0% (90.6-99.5) were positive for one type, other type. The did not impact outcome time Vaccination generally well tolerated woman's status entry.

参考文章(27)
Sarah Coseo, Carolina Porras, Allan Hildesheim, Ana Cecilia Rodriguez, Mark Schiffman, Rolando Herrero, Sholom Wacholder, Paula Gonzalez, Sophia S Wang, Mark E Sherman, Silvia Jimenez, Diane Solomon, Catherine Bougelet, Leen-Jan van Doorn, Wim Quint, Mahboobeh Safaeian, Costa Rica HPV Vaccine Trial (CVT) Group, Seroprevalence and Correlates of Human Papillomavirus 16/18 Seropositivity Among Young Women in Costa Rica Sexually Transmitted Diseases. ,vol. 37, pp. 706- 714 ,(2010) , 10.1097/OLQ.0B013E3181E1A2C5
Jacques Ferlay, Hai-Rim Shin, Freddie Bray, David Forman, Colin Mathers, Donald Maxwell Parkin, Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. International Journal of Cancer. ,vol. 127, pp. 2893- 2917 ,(2010) , 10.1002/IJC.25516
F. Xavier Bosch, Ann N. Burchell, Mark Schiffman, Anna R. Giuliano, Silvia de Sanjose, Laia Bruni, Guillermo Tortolero-Luna, Susanne Kruger Kjaer, Nubia Muñoz, Epidemiology and natural history of human papillomavirus infections and type-specific implications in cervical neoplasia. Vaccine. ,vol. 26, ,(2008) , 10.1016/J.VACCINE.2008.05.064
Jan M. M. Walboomers, Marcel V. Jacobs, M. Michele Manos, F. Xavier Bosch, J. Alain Kummer, Keerti V. Shah, Peter J. F. Snijders, Julian Peto, Chris J. L. M. Meijer, Nubia Mu�oz, Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. The Journal of Pathology. ,vol. 189, pp. 12- 19 ,(1999) , 10.1002/(SICI)1096-9896(199909)189:1<12::AID-PATH431>3.0.CO;2-F
Allan Hildesheim, Rolando Herrero, Sholom Wacholder, Ana C Rodriguez, Diane Solomon, M Concepcion Bratti, John T Schiller, Paula Gonzalez, Gary Dubin, Carolina Porras, Silvia E Jimenez, Douglas R Lowy, for the Costa Rican HPV Vaccine Trial Group, None, Effect of human papillomavirus 16/18 L1 viruslike particle vaccine among young women with preexisting infection: a randomized trial. JAMA. ,vol. 298, pp. 743- 753 ,(2007) , 10.1001/JAMA.298.7.743
Sven-Eric Olsson, Susanne K Kjaer, Kristján Sigurdsson, Ole-Erik Iversen, Mauricio Hernandez-Avila, Cosette M Wheeler, Gonzalo Perez, Darron R Brown, Laura A Koutsky, Eng Hseon Tay, Patricia García, Kevin A Ault, Suzanne M Garland, Sepp Leodolter, Grace WK Tang, Daron G Ferris, Jorma Paavonen, Jorma Lehtinen, Marc Steben, F Xavier Bosch, Joakim Dillner, Elmar Joura, Slawomir Majewski, Nubia Muñoz, Evan R Myers, Luisa L Villa, None, Evaluation of quadrivalent HPV 6/11/16/18 vaccine efficacy against cervical and anogenital disease in subjects with serological evidence of prior vaccine type HPV infection. Human Vaccines. ,vol. 5, pp. 696- 704 ,(2009) , 10.4161/HV.5.10.9515
Mark Schiffman, Mahboobeh Safaeian, Nicolas Wentzensen, The use of human papillomavirus seroepidemiology to inform vaccine policy. Sexually Transmitted Diseases. ,vol. 36, pp. 675- 679 ,(2009) , 10.1097/OLQ.0B013E3181BCE102
J. J. Carter, L. A. Koutsky, G. C. Wipf, N. D. Christensen, S.-K. Lee, J. Kuypers, N. Kiviat, D. A. Galloway, The natural history of human papillomavirus type 16 capsid antibodies among a cohort of university women The Journal of Infectious Diseases. ,vol. 174, pp. 927- 936 ,(1996) , 10.1093/INFDIS/174.5.927
C WHEELER, C GREER, T BECKER, W HUNT, S ANDERSON, M MICHELEMANOS, Short-term fluctuations in the detection of cervical human papillomavirus DNA Obstetrics & Gynecology. ,vol. 88, pp. 261- 268 ,(1996) , 10.1016/0029-7844(96)00120-2
Francis J. Dessy, Sandra L. Giannini, Catherine A. Bougelet, Troy J. Kemp, Marie-Pierre M. David, Sylviane M. Poncelet, Ligia A. Pinto, Martine A. Wettendorff, Correlation between direct ELISA, single epitope-based inhibition ELISA and Pseudovirion-based neutralization assay for measuring anti-HPV-16 and anti-HPV-18 antibody response after vaccination with the AS04-adjuvanted HPV-16/18 cervical cancer vaccine Human Vaccines. ,vol. 4, pp. 425- 434 ,(2008) , 10.4161/HV.4.6.6912