Efficacy of HPV-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis

Final event-driven analysis of PATRICIA (NCT00122681). Women aged 15 to 25 were vaccinated at months 0, 1 and 6 with the HPV-16/18 AS04-adjuvanted vaccine or a hepatitis A control. Analyses were done in the according-to-protocol cohort for efficacy (vaccine 8,093, control 8,069), the total vaccinated cohort (9,319 and 9,325) and the TVC-naive cohort of women with no evidence of oncogenic HPV infection at baseline (5,822 and 5,819). The primary endpoint was efficacy against CIN2+ associated with HPV-16 or HPV-18 in women seronegative at baseline and DNA negative at baseline and month 6 for the corresponding type.

Mean follow-up was 34.9 months after the third dose. Vaccine efficacy against CIN2+ associated with HPV-16/18 was 92.9 percent (96.1 percent CI 79.9 to 98.3) in the primary analysis and 98.1 percent (88.4 to 100) with probable causality assigned in lesions with several oncogenic types. Efficacy against CIN2+ irrespective of HPV DNA in lesions was 30.4 percent in the total vaccinated cohort and 70.2 percent in the TVC-naive cohort; against CIN3+ it was 33.4 percent and 87.0 percent. Efficacy against CIN2+ associated with 12 non-vaccine oncogenic types was 54.0 percent, with individual cross-protection against HPV-31, HPV-33 and HPV-45.