Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women.

摘要: Summary Background The human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine was immunogenic, generally well tolerated, and effective against HPV-16 or HPV-18 infections, associated precancerous lesions in an event-triggered interim analysis of the phase III randomised, double-blind, controlled PApilloma TRIal Cancer In young Adults (PATRICIA). We now assess efficacy final event-driven analysis. Methods Women (15–25 years) were vaccinated at months 0, 1, 6. Analyses done according-to-protocol cohort for (ATP-E; vaccine, n=8093; control, n=8069), total (TVC, included all women receiving least one dose, regardless their baseline HPV status; represents general population, including those who are sexually active; n=9319; n=9325), TVC-naive (no evidence oncogenic infection baseline; before sexual debut; n=5822; n=5819). primary endpoint to cervical intraepithelial neoplasia 2+ (CIN2+) that with seronegative baseline, DNA negative month 6 corresponding type (ATP-E). This trial is registered ClinicalTrials.gov, number NCT00122681. Findings Mean follow-up 34·9 (SD 6·4) after third dose. Vaccine CIN2+ HPV-16/18 92·9% (96·1% CI 79·9–98·3) 98·1% (88·4–100) which probable causality assigned infected multiple types (ATP-E cohort). irrespective 30·4% (16·4–42·1) TVC 70·2% (54·7–80·9) TVC-naive. Corresponding values CIN3+ 33·4% (9·1–51·5) 87·0% (54·9–97·7) 12 non-vaccine 54·0% (34·0–68·4; ATP-E). Individual cross-protection HPV-31, HPV-33, HPV-45 seen TVC. Interpretation showed high substantial overall effect cohorts relevant universal mass vaccination catch-up programmes. Funding GlaxoSmithKline Biologicals.