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 Generally HPV-Naive Women Aged 16–26 Years

• Published in: 24th International Papillomavirus Conference and Clinical Workshop,2007-11-03 - 2007-11-09 Vol. 199; no. 7; pp. 926 - 935
• Main Authors: Brown, Darron R., Kjaer, Susanne K., Sigurdsson, Kristján, Iversen, Ole-Erik, Hernandez-Avila, Mauricio, Wheeler, Cosette M., Perez, Gonzalo, Koutsky, Laura A., Tay, Eng Hseon, Garcia, Patricía, Ault, Kevin A., Garland, Suzanne M., Leodolter, Sepp, Olsson, Sven-Eric, Tang, Grace W. K., Ferris, Daron G., Paavonen, Jorma, Steben, Marc, Bosch, F. Xavier, Dillner, Joakim, Joura, Elmar A., Kurman, Robert J., Majewski, Slawomir, Muñoz, Nubia, Myers, Evan R., Villa, Luisa L., Taddeo, Frank J., Roberts, Christine, Tadesse, Amha, Bryan, Janine, Lupinacci, Lisa C., Giacoletti, Katherine E. D., Sings, Heather L., James, Margaret, Hesley, Teresa M., Barr, Eliav
• Format: Journal Article Conference Proceeding
• Language: English
• Published: Oxford The University of Chicago Press 01.04.2009; University of Chicago Press; Oxford University Press
• Subjects: Adenocarcinoma; Adolescent; Adult; Alphapapillomavirus - classification; Alphapapillomavirus - genetics; Alphapapillomavirus - immunology; Applied microbiology; Biological and medical sciences; Cervical cancer; Cervical intraepithelial neoplasia; Clinical Medicine; Fees; Female; Fundamental and applied biological sciences. Psychology; Human papillomavirus; Humans; Infections; Infectious diseases; Infectious Medicine; Infektionsmedicin; Klinisk medicin; Lesions; Medical and Health Sciences; Medical sciences; Medicin och hälsovetenskap; Microbiology; Miscellaneous; Obstetrics; Papillomavirus Infections - prevention & control; Papillomavirus Infections - virology; Papillomavirus Vaccines; Placebos; Uterine Cervical Neoplasms - prevention & control; Uterine Cervical Neoplasms - virology; Vaccination; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Virology; Viruses; Young Adult; Papillomavirus; Virus; Human; Infection; Human papillomavirus 16; Human papillomavirus; Microbiology; Virus like particle; Female; Vaccine; Papovaviridae
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1086/597307

BackgroundHuman papillomavirus (HPV)–6/11/16/18 vaccine reduces the risk of HPV-6/11/16/18–related cervical intraepithelial neoplasia (CIN) 1–3 or adenocarcinoma in situ (AIS). Here, its impact on CIN1–3/AIS associated with nonvaccine oncogenic HPV types was evaluated MethodsWe enrolled 17,622 women aged 16–26 years. All underwent cervicovaginal sampling and Pap testing at regular intervals for up to 4 years. HPV genotying was performed for biopsy samples, and histological diagnoses were determined by a pathology panel. Analyses were conducted among subjects who were negative for 14 HPV types on day 1. Prespecified analyses included infection of ⩾6 months’ duration and CIN1–3/AIS due to the 2 and 5 most common HPV types in cervical cancer after HPV types 16 and 18, as well as all tested nonvaccine types ResultsVaccination reduced the incidence of HPV-31/45 infection by 40.3% (95% confidence interval [CI], 13.9% to 59.0%) and of CIN1–3/AIS by 43.6% (95% CI, 12.9% to 64.1%), respectively. The reduction in HPV-31/33/45/52/58 infection and CIN1–3/AIS was 25.0% (95% CI, 5.0% to 40.9%) and 29.2% (95% CI, 8.3% to 45.5%), respectively. Efficacy for CIN2–3/AIS associated with the 10 nonvaccine HPV types was 32.5% (95% CI, 6.0% to 51.9%). Reductions were most notable for HPV-31 ConclusionsHPV-6/11/16/18 vaccine reduced the risk of CIN2–3/AIS associated with nonvaccine types responsible for ∼20% of cervical cancers. The clinical benefit of cross-protection is not expected to be fully additive to the efficacy already observed against HPV-6/11/16/18–related disease, because women may have >1 CIN lesion, each associated with a different HPV type Trial registrationClinicalTrials.gov identifiers: NCT00092521, NCT00092534, and NCT00092482