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FDA approves Cervarix, GlaxoSmithKline’s cervical cancer vaccine gsk.com | Vaccine for Boys and Young Men, Cervarix for Girls and Young... hivandhepatitis.com |
See also: HPV vaccine
Cervarix is a vaccine against certain types of cancer-causing human papillomavirus (HPV). Cervarix is designed to prevent infection from HPV types 16 and 18, which currently cause about 70% of cervical cancer cases. Type 16 is also associated with oropharyngeal squamous-cell carcinoma, a form of throat cancer.[1] Additionally, some cross-reactive protection against virus strains 45 and 31 were shown in clinical trials.[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] Cervarix is manufactured by GlaxoSmithKline. An alternative product, from Merck & Co., is known as Gardasil.
[edit] IndicationsHPV is a sexually transmitted virus, which causes cervical cancer in a small percentage of those infected. Cervarix is a preventative HPV vaccine, not therapeutic. HPV immunity is type-specific, so a successful series of Cervarix shots will not block infection from cervical cancer-causing HPV types other than HPV types 16 and 18, so experts continue to recommend routine cervical Pap smears even for women who have been vaccinated. [edit] Ingredients
3-O-desacyl-4’- monophosphoryl lipid A (MPL) 50 micrograms
L1 protein is in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from the insect Trichoplusia ni. The other ingredients are sodium chloride (NaCl), sodium dihydrogen phosphate dihydrate (NaH2PO4.2 H2O) and water for injections.[4] [edit] BiotechnologyCervarix 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.[5] [edit] AdjuvantAdjuvant system 04 (AS04), contains aluminum hydroxide and monophosphoryl lipid A.[6] Monophosphoryl lipid A, may also boost naturally-occurring antibodies to cholesterol anticholesterol.[7] [edit] Clinical trialsPhase II trials demonstrated 100% protection of the vaccine against types 16 and 18 HPV, including among 1100 women from North America and Brazil.[8] 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.[9] Vaccination has been shown to offer protection for at least 6.4 years.[10][11] 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.[12] [edit] Regulatory approval
[edit] UseCervarix is used by the UK government for its national programme of vaccination for teenage and pre-teenage girls. This caused some controversy since Cervarix was chosen over Gardasil, even though Gardasil protects against other HPV types 6 and 11 (which cause genital warts).[20] The study found that Cervarix generated more than 2x more antibodies than Gardasil for HPV type 16 and more than 6x more for HPV type 18 at seven months in all women aged 18–45 years (P<0.0001). At seven months Cervarix also induced 2.7x more memory B cells than Gardasil for both HPV types 16 and 18 (P<0.0001) in women with no detectable B-cell response before vaccination. Cervarix has been used to vaccinate girls aged 12–13 and 17–18 against HPV as part of the UK Government’s cervical cancer vaccination campaign. The vaccine utilises the AS04 (Aka. "Adjuvant System 04") a trade name for combination of adjuvants used in various vaccine product by GlaxoSmithKline (GSK). It consists of aluminum hydroxide and monophosphoryl lipid A (MPL) [edit]On 28 September 2009, a 14 year-old schoolgirl died hours after receiving the vaccination in England.[21]. A subsequent statement by the relevant NHS Trust said that her death was "most unlikely" to have been caused by the vaccine, and that she had a "serious underlying medical condition which was likely to have caused death".[22]. A full post-mortem identified the cause of death was from a malignant tumour of the chest.[23] [edit] Lead researcher comes out against vaccinesDr. Diane Harper, a HPV vaccine researcher, stated that in countries where Pap smear screening is common, it will take vaccination of a large proportion of women in order to further reduce cervical cancer rates. She also stated that no efficacy trials for children under 15 have been performed.[24][25] [edit] References
[edit] External links
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