GlaxoSmithKline Study Group reports sustained efficacy over HPV types linked to cervical cancer
THURSDAY, Dec. 3 (HealthDay News) -- The human papillomavirus (HPV) vaccine from GlaxoSmithKline (Cervarix) provides protection beyond six years from infection by HPV-16 and HPV-18, the HPV types most commonly associated with cervical cancer, according to a study published online on Dec. 3 in The Lancet.
Cosette Wheeler, Ph.D., of the University of New Mexico in Albuquerque, and colleagues from the GlaxoSmithKline Vaccine HPV-007 study group, followed up an earlier study in which 1,113 women ages 15 to 25 years, without HPV infection at baseline, were randomized to receive either HPV vaccination (HPV-16/18 AS04-adjuvanted vaccine) or placebo. In the follow-up study, cervical samples were tested for HPV DNA at six-month intervals for 393 of the vaccinated group and 383 of the placebo group to assess the vaccine's continued efficacy, immunogenicity, and safety.
In 6.4 years of follow-up, the researchers found antibody concentrations remained high in the vaccinated group. The vaccine efficacy against HPV infection was 95.3 percent overall and was 100 percent against 12-month persistent infection. Vaccine efficacy also was 100 percent for cervical intraepithelial neoplasia grade 2 and above for lesions associated with HPV, and was 71.9 percent for lesions not associated with HPV. Eight percent of vaccinated women reported a serious adverse event compared to 10 percent in the placebo group.
"In conclusion, the HPV-16/18 AS04-adjuvanted vaccine provides a high level of protection against HPV-16 and HPV-18 infection and associated cytohistological end points for up to 6.4 years," the authors write.
The study was funded by GlaxoSmithKline Biologicals (Belgium), which makes the HPV vaccine, and three authors are GlaxoSmithKline employees. Several of the study authors reported receiving consulting, lecture and other fees from pharmaceutical companies, including GlaxoSmithKline.
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