Researchers affiliated with three randomized trials involving the quadrivalent human papillomavirus vaccine (Gardasil) have reported the combined results in the May 19, 2007 issue of The Lancet. They concluded that Gardasil was effective in preventing high-grade vulval and vaginal lesions associated with HPV16 or HPV18 in women unexposed to these types before vaccination.  

Several recent reports have documented the efficacy of Gardasil in preventing pre-neoplastic and neoplastic lesions of the cervix, oropharynx and anogenital area associated with HPV. 

The current study combines the data from three randomized trials in 18,174 women between the ages of 16 and 26 years. These women were followed for a mean time of 3 years and a minimum time of 2 years. The vaccine was 100% effective in preventing high-grade vulval intraepithelial neoplasia and vaginal intraepithelial in women who were not exposed to HPV16 and 18. The vaccine was 71% effective on an intention to treat basis where women could or could not have been previously exposed to HPV16 and 18. 

Comments: These data are similar to that reported in the New England Journal of Medicine for the Future II Study which included 12,000 women. (see related news)

References:  Joura EA, Miernandez-Avila M, Wheeler CM, et al. Efficacy of a quadrivalent prophylactic human papillomavius (thyes 6, 11, 16, and 18) L1 virus-like particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomized clinical trials. The Lancet. 2007; 369:1693-1702.

Related News:  

Gardasil® Prevents High-Grade Cervical Neoplasia Related to Human Papilloma Virus (HPV) (05/14/2007)

Gardasil® Vaccine Reduces Incidence of Anogenital Diseases in Young Women (5/14/2007)

Confirmation of Association of Oral HPV Infection and Head and Neck Cancers (5/11/2007)

Prevalence of HPV in the U.S. Greater than Previously Thought (03/01/2007)

HPV Vaccine Shows Sustained Efficacy (04/11/2006)

Human Papillomavirus (HPV) Vaccine Has Prolonged Prevention of Cervical Neoplasia (02/01/2006)

Human Papilloma Virus Associated with Oral and Oropharyngeal Cancer (12/10/2003)

Human Papilloma Virus Infections May Explain Head and Neck Cancers Not Caused by Tobacco and Alcohol Exposure (11/17/2003)