Cervarix

See also: HPV vaccine

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 HPV-related cervical cancer cases. Type 16 has also been found to be associated with oropharyngeal squamous-cell carcinoma, a form of throat cancer.^{[1] [2]} 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.^[3]

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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 cannot 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 ^[4] .

Indications

Cervarix is a preventative cervical cancer vaccine, not therapeutic. HPV immunity is type-specific, so a successful series of Cervarix shots will not block infection from cervical cancer-causing HPV strains other than HPV 16 and 18 so experts continue to recommend routine cervical Pap smears even for women who have been vaccinated.

Administration

Phase II trials demonstrated 100% protection of the vaccine against types 16 and 18 HPV, including among 1100 women from North America and Brazil.^[5] Phase III trials included over 660 women from Germany and Poland and backed up results from phase II showing a relative reduction of about 90% in cervical precancerous lesions compared to placebo, however, no statistically significant reduction was observed for HPV 18 alone. Company officials are now conducting a clinical trial to determine whether Cervarix is more immunogenic than rival Merck's HPV vaccine Gardasil.^[6]

Longevity of the vaccination has proven so far to be at least 5.5 years.^[7] 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.^[8]

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.^[9]

It received approval in May 2007 in Australia for women ages 10 to 45.^[10]. On August 25, 2007 GlaxoSmithKline launched Cervarix in the Philippines after approval by the local Bureau of Food and Drugs.^[11]

References