Everything about Cervarix totally explained
Cervarix is a
vaccine against certain types of the
human papillomavirus (HPV) that cause cervical cancer, manufactured by
GlaxoSmithKline. It is designed to prevent infection from HPV types 16 and 18, which currently cause about 70% of
cervical cancer cases. Type 16 has also been found to be associated with oropharyngeal squamous-cell carcinoma, a form of throat cancer. Additionally, some cross-reactive protection against virus strains 45 and 31 were shown in clinical trials. Cervarix is also formulated with AS04, a
proprietary adjuvant that has been found to boost the
immune system response for a longer period of time.
Biotechnology
Cervarix is created using the L1 protein of the viral
capsid. Recombinant activity in a baculovirus vector produces L1 protein spheres, which are very immunogenic. The
viral proteins induce the formation of neutralizing antibodies. The vaccine contains no live virus and no DNA, so it can't infect the patient. The vaccine was developed, in parallel, by researchers at
Georgetown University Medical Center, the
University of Rochester, the
University of Queensland in Australia, and the U.S.
National Cancer Institute .
Indications
Cervarix is a preventative cervical cancer vaccine, not therapeutic. HPV immunity is type-specific, so a successful series of Cervarix shots won't block infection from cervical cancer-causing HPV strains other than HPV 16, 18, 31 and 45, so experts continue to recommend routine cervical Pap smears even for women who have been vaccinated.
Clinical trials
Phase II trials demonstrated 100% protection of the vaccine against types 16 and 18 HPV, including among 1100 women from
North America and
Brazil. Phase III trials included over 660 women from
Germany and
Poland. Company officials are now conducting a clinical trial to determine whether Cervarix is more effective than rival Merck's HPV vaccine
Gardasil.
Longevity of the vaccination has proven so far to be at least 5.5 years. In the clinical trials, women were given three doses over a six-month span -- at 0 month, 1 month, and 6 months. The technology used in this vaccine was licensed from the
University of Rochester.
Regulatory Approval
On
March 29,
2007 GlaxoSmithKline submitted a Biologics License Application (BLA) for Cervarix (human papillomavirus vaccine, AS04 adjuvant-adsorbed), to the
FDA which included data from clinical trials in almost 30,000 females 10 to 55 years of age and contains data from the largest Phase III cervical cancer vaccine efficacy trial to date.
It received approval in May 2007 in Australia for women ages 10 to 45.. On August 25, 2007 GlaxoSmithKline launched Cervarix in the
Philippines after approval by the local Bureau of Food and Drugs.
Bold textFurther Information
Get more info on 'Cervarix'.
|
External Link Exchanges
Do you know how hard it is to get a link from a large encyclopaedia? Well we're different and will prove it. To get a link from us just add the following HTML to your site on a relevant page:
<a href="http://cervarix.totallyexplained.com">Cervarix Totally Explained</a>
Then simply click through this link from your web page. Our crawlers will verify your link, extract the title of your web page and instantly add a link back to it. If you like you can remove the words Totally Explained and embed the link in article text.
As long as your link remains in place, we'll keep our link to you right here. Please play fair - our crawlers are watching. Your site must be closely related to this one's topic. Any kind of spamming, dubious practises or removing the link will result in your link from us being dropped and, potentially, your whole site being banned. |
