More support for cervical CA vaccine

June 1, 2005

A vaccine against human papillomavirus (HPV) types 6 and 11 (responsible for 90% of genital warts) and types 16 and 18 (responsible for 70% of cervical cancers) safely and effectively reduced persistent infection and disease by 90% in a randomized, double-blind, placebo-controlled, phase II trial.

A vaccine against human papillomavirus (HPV) types 6 and 11 (responsible for 90% of genital warts) and types 16 and 18 (responsible for 70% of cervical cancers) safely and effectively reduced persistent infection and disease by 90% in a randomized, double-blind, placebo-controlled, phase II trial. The results are consistent with two previous studies that have found HPV vaccines effective against cervical cancer.

The study included more than 500 non-pregnant women from Brazil, Europe, and the US with a mean age of approximately 20 years. One group of women received three active vaccines via intramuscular injection at Day 1, Month 2, and Month 6, while another group received one of two placebo preparations at the same time intervals. Follow-up continued for 3 years.

The vaccine was effective and generally well tolerated. Most (94%) adverse events were mild or moderate in intensity; only one patient discontinued treatment. Pain was the most common injection site event; headache was the most common systemic event. Since women are at risk for HPV infection for as long as they are sexually active, it is unclear at this point whether booster doses will be necessary to provide protection beyond a 3-year period.