Merck's human papilloma virus vaccine Gardasil was 100% effective in preventing cervical cancer in the company's primary analysis of a Phase III trial.

The company announced results of the FUTURE II study Oct. 6; it will present the data at the Infectious Diseases Society of America annual meeting Oct. 7.

FUTURE II evaluated the incidence of HPV 16/18-related cervical pre-cancers (cervical intraepithelial neoplasia grades 2 and 3) and non-invasive cancers (adenocarcinoma in situ) in 12,167 patients receiving three doses of Gardasil or placebo.

The primary analysis evaluated women ages 16 to 26 who had no major protocol violations and remained free of HPV infection through the six-month vaccine regimen. Patients were followed for an average of 17 months after receiving the three-vaccine series.

"Gardasil prevented 100% of cases of high-grade pre-cancer and non-invasive cancer (CIN 2/3 or AIS) associated with HPV types 16 and 18," Merck said.

There were no recorded cases of CIN 2/3 or AIS in the vaccine group (n=5,301), compared with 21 cases in patients receiving placebo.

In a secondary analysis, which included women in the primary analysis group as well as those who may have become infected with HPV 16 or 18 during the vaccination period and those who violated protocol, the vaccine was shown to be 97% effective.

At an average of two years of follow-up, one case of CIN 2/3 or AIS was observed in the vaccine group (n=5,736) versus 36 in the placebo group.

Merck plans to submit the Gardasil BLA to FDA in the fourth quarter of this year.

Gardasil targets HPV types 16 and 18, which account for 70% of cervical cancers, and types 6 and 11, which account for 90% of genital wart cases.

GlaxoSmithKline's HPV vaccine Cervarix , which is behind Gardasil in development, includes HPV types 16 and 18 (¹ Also see "Teen Vaccine Approvals Increasing, FDA Says" - Pink Sheet, 2 June, 2005.).

- Mary Bruce

Merck HPV Vaccine Gardasil Shows 100% Efficacy In Phase III Primary Analysis

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