• 6/20/2006
  • Iowa City, IA
  • staff
  • CancerConsultants.com

Cervarix™, GlaxoSmithKline’s cervical cancer vaccine candidate, produced an antibody response against human papillomavirus (HPV) types 16 and 18 in 100% of vaccinated women between the ages of 15 and 55 years. These results were presented at the 2006 annual meeting of the American Society of Clinical Oncology (ASCO).

HPV types 16 and 18 account for roughly 70% of all cases of cervical cancer. Cervarix, a bivalent L1 virus-like particle vaccine, is intended to prevent infection with these high-risk types of HPV, and may also offer some protection against two other high-risk types of HPV – types 45 and 31.

The results presented at ASCO were from a phase III clinical trial conducted among 666 women between the ages of 15 and 55 years. Three doses of vaccine were administered over a six month period, and antibody levels were assessed at 7 and 12 months.

– 100% of women had detectable antibodies to HPV types 16 and 18 at month 7 and month 12.

– The antibody levels at month 12 were several times higher than would be expected after natural infection

– Although geometric mean antibody titers declined with age, the levels observed in the oldest group of women are still expected to provide protection.

This study suggests that Cervarix may protect against infection in older as well as younger women. GlaxoSmithKline is expected to submit an application for approval of its vaccine to the U.S. Food and Drug Administration (FDA) by the end of 2006.

Reference:
Schwarz TF. An AS04-containing Human Papillomavirus (HPV) 16/18 Vaccine for Prevention of Cervical Cancer is Immunogenic and Well-tolerated in Women 15-55 Years Old. Proceedings from the 42nd annual meeting of the American Society of Clinical Oncology. Atlanta, Ga. June 2006. Abstract # 1008.