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PATRICIA: HPV vaccine prevented precancerous cervical lesions
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The HPV-16/18 AS04-adjuvanted vaccine was efficacious against cervical intraepithelial neoplasia 2+ lesions, according to data from a final analysis of the Papilloma Trial Against Cancer in Young Adults (PATRICIA) study.
Researchers randomly assigned women aged 15-25 years to HPV-16/18 AS04-adjuvanted vaccine (Cervarix, GlaxoSmithKline) or to a control hepatitis A vaccine (GlaxoSmithKline) at zero, one and six months and assessed the efficacy of HPV-16/18 AS04-adjuvanted vaccine against CIN 2+.
Analyses were performed in a total vaccination cohort (n=18,644), an according-to-protocol cohort for efficacy (n=16,162) and a total vaccination-naive cohort (n=11,641). The mean follow-up was 34.9 months after the third vaccination.
In a primary analysis, vaccine efficacy against CIN 2+ associated with HPV-16/18 in women who were seronegative at baseline and DNA negative at six months was 92.9% (96.1% CI, 79.9-98.3).
In an additional analysis of women with lesions with more than one HPV type, researchers used an HPV type assignment algorithm to assign a likely causal association between a lesion and the HPV type. Causality was based on the detection of the same HPV type in previous cytology samples. In this analysis, vaccine efficacy was 98.1% (96.1% CI, 88.4-100).
In analysis of CIN 2+ lesions regardless of HPV DNA, vaccine efficacy was 30.4% (96.1% CI, 16.4-42.1) in the total vaccinated cohort and 70.2% (96.1% CI, 54.7-80.9) in the total vaccinated-naive cohort.
Vaccine efficacy against CIN 3+ lesions was 33.4% (96.1% CI, 9.1-51.5) in the total vaccinated cohort and 87.0% (96.1% CI, 54.9-97.7) in the total vaccinated-naive cohort. For CIN 2+, vaccine efficacy for any oncogenic type except HPV-16/18 was 54.0% (96.1% CI, 34.0-68.4).
The researchers also noted that the HPV-16/18 AS04-adjuvanted vaccine demonstrated overall efficacy in cohorts relevant to universal mass vaccination and catch-up programs.
Paavonen J. Lancet. 2009;doi:10.1016/S0140-6736(09)61248-4.