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Gardasil Vaccine Shows 100% Efficacy in Preventing High-Grade Cervical Pre-Cancers and Non-Invasive Cancers

Strategic Insights

— 2 min read

A new phase III study of the investigational vaccine Gardasil, developed by Merck & Co., Inc., has shown a 100% effectiveness in preventing high-grade cervical pre-cancers and non-invasive cervical cancers associated with human papillomavirus (HPV) types 16 and 18. The study, titled FUTURE II, involved over 12,000 women from 13 countries and was presented at the Infectious Diseases Society of America (IDSA) annual meeting. The results are part of the ongoing phase III program for Gardasil, which involves over 25,000 people in 33 countries worldwide.

The trial, which aimed to evaluate the incidence of HPV 16/18-related cervical pre-cancers known as CIN (cervical intraepithelial neoplasia) 2/3 and non-invasive cancers, found that Gardasil prevented 100% of cases of high-grade pre-cancer and non-invasive cancer associated with HPV types 16 and 18 in women who received three doses of the vaccine, had no major protocol violations, and remained free of HPV 16 and/or 18 infection through month 7. In a broader group of women, including those who may have become infected with HPV 16 or 18 during the vaccination period and those who may have violated the protocol in significant ways, Gardasil reduced the risk of developing high-grade pre-cancer and non-invasive cancer by 97%.

Key Takeaways:

  • Gardasil, a quadrivalent human papillomavirus types 6, 11, 16, 18 recombinant vaccine, has shown a 100% effectiveness in preventing high-grade cervical pre-cancers and non-invasive cervical cancers associated with HPV types 16 and 18 in over 12,000 women from 13 countries.
  • The study found that Gardasil prevented 100% of cases of high-grade pre-cancer and non-invasive cancer associated with HPV types 16 and 18 in women who received three doses of the vaccine and had no major protocol violations.
  • In a broader group of women, Gardasil reduced the risk of developing high-grade pre-cancer and non-invasive cancer by 97%, with one case observed in the vaccine group compared to 36 in the placebo group.
  • The most common vaccine-related adverse event reported was local discomfort at the injection site.
  • Gardasil was designed to target HPV types 16 and 18, which account for 70% of cervical cancers, and HPV types 6 and 11, which account for 90% of cases of genital warts.

Statistics:

  • 100% of high-grade cervical pre-cancers and non-invasive cervical cancers associated with HPV types 16 and 18 were prevented in women who received three doses of Gardasil and had no major protocol violations.
  • 97% reduction in risk of developing high-grade pre-cancer and non-invasive cancer associated with HPV types 16 and 18 was observed in a broader group of women.
  • 12,167 women were enrolled in the study, with 6,082 females receiving Gardasil and 6,075 receiving placebo.
  • 1 case of high-grade pre-cancer and non-invasive cancer was observed in the vaccine group compared to 36 in the placebo group.
  • The most common vaccine-related adverse event reported was local discomfort at the injection site (35.7% in the Gardasil group vs 30.4% in the placebo group).

Sources:

  • Health & Medicine Week editors from staff and other reports, "Gardasil Vaccine Shows 100% Efficacy in Preventing High-Grade Cervical Pre-Cancers and Non-Invasive Cancers," Health & Medicine Week via NewsRx.com, 2005.
  • Merck & Co., Inc., press release, "Merck Announces Positive Phase III Results for Gardasil, a Vaccine Against Human Papillomavirus Types 6, 11, 16 and 18," 2005.
  • Infectious Diseases Society of America (IDSA), presentation at the IDSA annual meeting, "Gardasil: A Vaccine Against Human Papillomavirus Types 6, 11, 16 and 18," 2005.

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