PATRICIA

PATRICIA (PApilloma TRIal against Cancer In young Adults; Cervarix product information study HPV-008; NCT00122681) was a multinational, double-blind, randomised, controlled phase 3 trial of the HPV-16/18 AS04-adjuvanted vaccine in women aged 15 to 25 years. Women received the HPV vaccine or a hepatitis A vaccine control at months 0, 1 and 6.

The primary endpoint was vaccine efficacy against cervical intraepithelial neoplasia grade 2 or worse (CIN2+) associated with HPV-16 or HPV-18 in the according-to-protocol cohort for efficacy (women seronegative at baseline and DNA negative at baseline and month 6 for the corresponding type; vaccine 8,093, control 8,069). In the Lancet 2009 final event-driven analysis, after a mean follow-up of 34.9 months from the third dose, vaccine efficacy 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) when probable causality to HPV type was assigned in lesions infected with several oncogenic types. Efficacy against CIN2+ irrespective of HPV type was 30.4 percent in the total vaccinated cohort and 70.2 percent in women with no evidence of oncogenic HPV infection at baseline, and cross-protection against CIN2+ associated with HPV-31, HPV-33 and HPV-45 was seen.

The Cervarix product information names the study HPV-008 and quotes the same 92.9 percent event-triggered figure. ClinicalTrials.gov registers the trial with condition papillomavirus infection rather than a cancer, which is why the automated pass never attached it to the vaccine record.