GlaxoSmithKline Says HPV Vaccine Worked in Study

Reporting the results of a study published in the Lancet, GlaxoSmithKline PLC (GSK) said Tuesday that its human papillomavirus vaccine Cervarix was effective not only against HPV strains most likely to cause cervical cancer but also other strains of the STD.

The subjects of the late-stage trial were 18,644 females ages 15 to 25. They included females with evidence of past or current HPV infection or high-grade Pap smear results, plus others with no evidence of current or previous HPV infection. Case subjects received Cervarix; control subjects received hepatitis A vaccine. The shots were administered at baseline, one month and six months.

The trial sought to test the efficacy of Cervarix against HPV types 16 and 18, the strains most likely to result in cervical cancer. Women who received all three doses of the HPV vaccine achieved 92.9 percent protection. Excluding some lesions not likely caused by HPV types 16 or 18, GSK said the vaccine provided 98.1 percent protection against those strains. In addition, the researchers noted evidence that Cervarix was protective against HPV types 31, 33, and 45. GSK said this was the first time any HPV vaccine evidenced significant protection against precancerous lesions caused by other HPV strains.

Cervarix is already in use in the European Union and many other nations. A decision by the Food and Drug Administration on whether to approve the vaccine for use in the United States could come by autumn.

The report, "Efficacy of Human Papillomavirus (HPV)-16/18 AS04-Adjuvanted Vaccine Against Cervical Infection and Precancer Caused by Oncogenic HPV Types (PATRICIA): Final Analysis of a Double-Blind, Randomized Study in Young Women," was published in the Lancet (07.07.09; doi:10.1016/S0140-6736(09)61248-4).

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