Dec 19 2005
Drug company GlaxoSmithKline have had a good result with their new vaccine which was designed to prevent infection with the virus that causes cervical cancer.
The company in describing the results of a late-stage trial say that girls aged 10 to 14 who received the vaccine had immune responses twice as strong as women 15-25 years old given the vaccine.
According to Glaxo the initial data from a phase III trial of its Cervarix vaccine suggest it may provide the strongest and most-prolonged protection if given to girls at very young ages, long before they encounter the sexually transmitted virus.
Gary Dubin, a senior research official at Glaxo who was the lead author on the study, says the concentrations of antibodies to the virus were twice as high in the bloodstreams of the young girls.
Antibodies are immune-system proteins that seek out and destroy bacteria and viruses.
Vaccines introducing the body to snippets of specific bacteria or viruses, and train the body to produce tailor-made antibodies that attack them.
Dubin says the trial was not designed to confirm actual effectiveness of the vaccine because few girls in the 10 to 14 age group are sexually active.
Instead, he says the immune response is the best "surrogate" indicator of the vaccine's potential ability to protect them from prolonged infection with the virus.
The results of the trial were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, D.C.
Glaxo itself financed the trial, which was conducted in Europe and Russia.
The trial involved 158 healthy girls aged 10-14 and 458 women aged 15-25 who received three doses of the vaccine over a six month period.
Cervarix has not yet been submitted for regulatory approvals, but is considered one of the most important experimental products being developed by the British drugmaker.
It will probably eventually be in competition with a similar Merck and Co. vaccine, Gardasil, that is already awaiting approval from U.S. and European regulators.
As with Gardasil, the Glaxo product blocks infection with two strains of human papillomavirus that are responsible for about 70 percent of cases of cervical cancer which is the second most common fatal cancer in women.
http://www.gsk.com