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Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial

BMJ, 2010-07, Vol.341 (7766), p.239-239 [Peer Reviewed Journal]

The FUTURE I/II Study Group 2010 ;2010 BMJ Publishing Group Ltd ;Copyright: 2010 © The FUTURE I/II Study Group 2010 ;The FUTURE I/II Study Group 2010 2010 The FUTURE I/II Study Group ;ISSN: 0959-8138 ;ISSN: 0959-8146 ;ISSN: 1756-1833 ;EISSN: 1468-5833 ;EISSN: 1756-1833 ;DOI: 10.1136/bmj.c3493 ;PMID: 20647284 ;CODEN: BMJOAE

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Title:
Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial
Author: Dillner, Joakim ; Kjaer, Susanne K ; Wheeler, Cosette M ; Sigurdsson, Kristján ; Iversen, Ole-Erik ; Hernandez-Avila, Mauricio ; Perez, Gonzalo ; Brown, Darron R ; Koutsky, Laura A ; Tay, Eng Hseon ; García, Patricia ; Ault, Kevin A ; Garland, Suzanne M ; Leodolter, Sepp ; Olsson, Sven-Eric ; Tang, Grace W K ; Ferris, Daron G ; Paavonen, Jorma ; Lehtinen, Matti ; Steben, Marc ; Bosch, F Xavier ; Joura, Elmar A ; Majewski, Slawomir ; Muñoz, Nubia ; Myers, Evan R ; Villa, Luisa L ; Taddeo, Frank J ; Roberts, Christine ; Tadesse, Amha ; Bryan, Janine T ; Maansson, Roger ; Lu, Shuang ; Vuocolo, Scott ; Hesley, Teresa M ; Barr, Eliav ; Haupt, Richard
Subjects: Adolescent ; Adult ; Anogenital ; Basic Medicine ; Cancer Vaccines ; Carcinoma in Situ - prevention & control ; Cervical cancer ; Cervical Intraepithelial Neoplasia - prevention & control ; Cleveland Clinic CME ; Clinical trials ; Clinical trials (epidemiology) ; Condylomata Acuminata - prevention & control ; Dermatology ; Double-Blind Method ; Epidemiology ; Evidence-based medicine ; Female ; Gynecological cancer ; Human papillomavirus ; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 ; Humans ; Immunization ; Immunology (including allergy) ; Infectious diseases ; Lesions ; Medical and Health Sciences ; Medicin och hälsovetenskap ; Medicinska och farmaceutiska grundvetenskaper ; Microbiology in the medical area ; Mikrobiologi inom det medicinska området ; Motivation ; Neoplasia ; Papillomavirus Infections - prevention & control ; Papillomavirus Vaccines ; Population control ; Population studies ; Pregnancy ; Reproductive medicine ; Serotypes ; Sexual health ; Sexual partners ; Treatment Outcome ; Urogenital Neoplasms - prevention & control ; Uterine Cervical Neoplasms - prevention & control ; Vaccination ; Vaccine efficacy ; Vaccines ; Vagina ; Vaginal Neoplasms - prevention & control ; Vulvar Neoplasms - prevention & control ; Warts ; Womens health ; Young Adult
Is Part Of: BMJ, 2010-07, Vol.341 (7766), p.239-239
Description: Objectives To evaluate the prophylactic efficacy of the human papillomavirus (HPV) quadrivalent vaccine in preventing low grade cervical, vulvar, and vaginal intraepithelial neoplasias and anogenital warts (condyloma acuminata).Design Data from two international, double blind, placebo controlled, randomised efficacy trials of quadrivalent HPV vaccine (protocol 013 (FUTURE I) and protocol 015 (FUTURE II)). The trials were to be 4 years in length, and the results reported are from final study data of 42 months’ follow-up.Setting Primary care centres and university or hospital associated health centres in 24 countries and territories around the world.Participants 17 622 women aged 16-26 years enrolled between December 2001 and May 2003. Major exclusion criteria were lifetime number of sexual partners (>4), history of abnormal cervical smear test results, and pregnancy.Intervention Three doses of quadrivalent HPV vaccine (for serotypes 6, 11, 16, and 18) or placebo at day 1, month 2, and month 6.Main outcome measures Vaccine efficacy against cervical, vulvar, and vaginal intraepithelial neoplasia grade I and condyloma in a per protocol susceptible population that included subjects who received all three vaccine doses, tested negative for the relevant vaccine HPV types at day 1 and remained negative through month 7, and had no major protocol violations. Intention to treat, generally HPV naive, and unrestricted susceptible populations were also studied.Results In the per protocol susceptible population, vaccine efficacy against lesions related to the HPV types in the vaccine was 96% for cervical intraepithelial neoplasia grade I (95% confidence interval 91% to 98%), 100% for both vulvar and vaginal intraepithelial neoplasia grade I (95% CIs 74% to 100%, 64% to 100% respectively), and 99% for condyloma (96% to 100%). Vaccine efficacy against any lesion (regardless of HPV type) in the generally naive population was 30% (17% to 41%), 75% (22% to 94%), and 48% (10% to 71%) for cervical, vulvar, and vaginal intraepithelial neoplasia grade I, respectively, and 83% (74% to 89%) for condyloma.Conclusions Quadrivalent HPV vaccine provided sustained protection against low grade lesions attributable to vaccine HPV types (6, 11, 16, and 18) and a substantial reduction in the burden of these diseases through 42 months of follow-up.Trial registrations NCT00092521 and NCT00092534.
Publisher: England: British Medical Journal Publishing Group
Language: English
Identifier: ISSN: 0959-8138
ISSN: 0959-8146
ISSN: 1756-1833
EISSN: 1468-5833
EISSN: 1756-1833
DOI: 10.1136/bmj.c3493
PMID: 20647284
CODEN: BMJOAE
Source: BMJ Open Access Journals
AUTh Library subscriptions: ProQuest Central
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Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial

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