HPV-16/18 Efficacious Against CIN3+, Adenocarcinoma in Situ

And, vaccine shows cross-protective efficacy against four oncogenic non-vaccine HPV types

WEDNESDAY, Nov. 9 (HealthDay News) -- The human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine shows excellent efficacy against CIN3+ and adenocarcinoma in situ (AIS), and cross-protective efficacy against four oncogenic non-vaccine HPV types, according to two studies published online Nov. 9 in The Lancet Oncology.

Matti Lehtinen, Ph.D., from the University of Tampere in Finland, and colleagues reported vaccine efficacy against CIN3+ and AIS in an end-of-study analysis of the PApilloma TRial against Cancer In young Adults (PATRICIA). Women aged 15 to 25 years were randomly allocated to receive the HPV-16/18 ASO4-adjuvanted vaccine or a control hepatitis A vaccine. CIN3+ and AIS were measured in the total vaccinated cohort (TVC), comprising all women who had at least one vaccine dose, and in the TVC-naive cohort, which comprised women with no evidence of oncogenic HPV infection at baseline. The investigators found that, for the TVC-naive and the TVC cohorts, vaccine efficacy against CIN3+ correlated with HPV-16/18 was 100 and 45.7 percent, respectively. Vaccine efficacy against all CIN3+ and against AIS was 93.2 and 100 percent, respectively, in the TVC-naive cohort, and 45.6 and 76.9 percent, respectively, in the TVC cohort.

In a second study, Lehtinen and colleagues assessed the efficacy of the HPV-16/18 AS04-adjuvanted vaccine against non-vaccine oncogenic HPV types after four years of follow-up in the PATRICIA study. Analyses were performed for three cohorts: the according-to-protocol cohort for efficacy, TVC-naive, and TVC. The vaccine was consistently efficacious against persistent infection and CIN2+ for HPV-33, -31, -45, and -51.

"Data from the end-of-study analysis of PATRICIA show cross-protective efficacy of the HPV-16/18 vaccine against four oncogenic non-vaccine HPV types," the authors write in the second study.

Several authors from both studies disclosed financial relationships with pharmaceutical companies, including GlaxoSmithKline Biologicals, which funded the studies and manufactures the HPV vaccine.

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