Evaluation of: Romanowski B, de Borba PC, Naud PS et a/.; GlaxoSmithKline Vaccine HPV-007 Study Group: Sustained efficacy and immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine: analysis of a randomised placebo-controlled trial up to 6.4 years. Lancet 374(9706), 1975-1985 (2009). Observational studies in three different countries assessed the efficacy of human papillomavirus (HPV)-16/18-AS04 adjuvanted vaccine in women who were naive to oncogenic HPV infection at the time of vaccination. A primary analysis of efficacy was conducted on the according-to-protocol cohort for efficacy for the virological end points and on the total vaccinated cohort for efficacy for the cytohistological end points. In the total vaccinated cohort, HPV-16/18-ASQ4 adjuvanted vaccine conferred protection against HPV-16/18 infection for up to 6.4 years after vaccination. This period is the longest reported for any H PV vaccine, indicating that boosters are not needed, which considerably decreases the complexity and costs of the delivery program, particularly in low-resource countries.
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