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Final Analysis Shows HPV Vaccine Highly Effective At Preventing Precancerous Cervical Lesions NEW YORK -- July 6, 2009 -- The final analysis of the Papilloma Trial to prevent Cervical Cancer in Young Adults (PATRICIA) study shows that the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine has high efficacy against the precancerous cervical lesions that can eventually lead to cervical cancer. The vaccine also shows cross-protective efficacy against other oncogenic HPV types closely related to HPV-16/18. It also shows efficacy in the cohorts relevant to universal mass vaccination and catch-up programmes. The findings are reported in an article published online first and appearing in an upcoming edition of The Lancet. Jorma Paavonen, MD, University of Helsinki, Helsinki, Finland, and colleagues looked at women aged 15 to 25 years who were vaccinated at months 0, 1, and 6. Analyses were done in the according-to-protocol cohort for efficacy (ATP-E; vaccine, n = 8093; control, n = 8069); the total vaccinated cohort (TVC; vaccine, n = 9319; control, n = 9325), and TVC-naïve (vaccine, n = 5822; control, n = 5819). The ATP-E group included all women who were given 3 vaccine doses, had normal pap smears or pap smears showing mild abnormalities at baseline. The TVC group included all women who received at least 1 vaccine dose, regardless of their baseline HPV status (represents young sexually active population), and the TCV-naïve group had no evidence of oncogenic HPV infection at baseline (represents women before sexual debut). The primary endpoint was to assess vaccine efficacy against cervical intraepithelial neoplasia 2+ (CIN2+). The mean follow-up was just under 3 years after the third dose. Vaccine efficacy against CIN2+ that was associated with HPV-16/18 was 93% in the primary analysis and 98% in an analysis in which causality to HPV type was assigned in lesions infected with multiple oncogenic types. Vaccine efficacy against CIN2+ irrespective of HPV type detected in lesions was 30% in the TVC group and 70% in the TVC-naïve group. Corresponding values against CIN3+ were 33% in the TVC group and 87% in TVC-naïve group, indicating the larger contribution of HPV-16/18 to this more serious grade of lesion. The vaccine was also shown to be protective against other oncogenic HPV types, most notably HPV-31 and HPV-45. Overall, the vaccine efficacy was calculated as between 37% and 54% against 12 non-vaccine oncogenic HPV types. Globally, around 70% of cervical cancer is estimated to be caused by HPV-16/18, with the remaining 30% caused by other oncogenic HPV types. Thus the cross-protective efficacy of this vaccine could represent 11% to 16% additional protection against cervical cancer to that afforded by efficacy against HPV-16/18. The authors note that the true incidence rate for CIN2+ lesions from non-vaccine HPV types could have been underestimated, since it takes longer for such lesions to develop compared with lesions caused by HPV-16/18, which is a limitation to the study. SOURCE: The Lancet E-mail this page to a friend or colleague! To print, use this version