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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;341:c3493
The FUTURE I/II Study Group
http://www.bmj.com/cgi/content/abstract/341/jul20_1/c3493

Dans l'analyse per protocole, en ne considérant que les lésions dues aux types de HPV présents dans le vaccin, l'efficacité à 42 mois est de 96 % contre les lésions cervicales de grade I et de 100 % pour les néoplasies vulvaires et vaginales. Pour les condylomes l'efficacité est de 99 %.
Dans la population générale, considérant tous les types de virus, chez des patientes ayant reçu au moins 1 injection de vaccin, situation plus proche de « la vraie vie », l'efficacité est de 30 % (17% to 41%) pour les CIN I, 75 % pour les lésions vulvaires et 48 % pour les lésions vaginales, alors que 83 % des condylomes sont évités.

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 [ClinicalTrials.gov] and NCT00092534 [ClinicalTrials.gov] .
© The FUTURE I/II Study Group 2010
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