Cervarix

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Cervarix
Vaccine description
Targethuman papillomavirus (Types 16 and 18)
Vaccine type Protein subunit
Clinical data
Trade names Cervarix
AHFS/Drugs.com Monograph
MedlinePlus a610014
Routes of
administration 		Intramuscular injection
ATC code
Legal status
Legal status
Identifiers
CAS Number
ChemSpider
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Cervarix is a vaccine against certain types of cancer-causing human papillomavirus (HPV).

Contents

Cervarix is designed to prevent infection from HPV types 16 and 18, that cause about 70% of cervical cancer cases. [6] These types also cause most HPV-induced genital and head and neck cancers. Additionally, some cross-reactive protection against virus strains 45 and 31 were shown in clinical trials. [7] Cervarix also contains AS04, a proprietary adjuvant that has been found to boost the immune system response for a longer period of time. [8]

Cervarix is manufactured by GlaxoSmithKline. An alternative product, from Merck & Co., is known as Gardasil. [6] Cervarix was voluntarily taken off of the market in the US in 2016 due to low demand. [9]

Medical uses

HPV is a virus, usually transmitted sexually, which can cause cervical cancer in a small percentage of those women genital 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 and some related types, so experts continue to recommend routine cervical Pap smears even for women who have been vaccinated. Vaccination alone, without continued screening, would prevent fewer cervical cancers than regular screening alone. [10] [11]

Cervarix is indicated for the prevention of the following diseases caused by oncogenic HPV types 16 and 18: cervical cancer, cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and CIN grade 1. In the United States, Cervarix is approved for use in females 10 through 25 years of age [12] while in some other countries the age limit is at least 45. [13]

As of September 2009, Cervarix was shown to be effective 7.3 years after vaccination. [14]

Administration

Immunization with Cervarix consists of 3 doses of 0.5-mL each, by intramuscular injection according to the following schedule: 0, 1, and 6 months. [6] The preferred site of administration is the deltoid region of the upper arm. [6] Cervarix is available in 0.5-mL single-dose vials and prefilled TIP-LOK syringes. [12]

Limitations of effectiveness

Cervarix does not provide protection against disease due to all HPV types, nor against disease if a woman has previously been exposed through sexual activity and protection may not be obtained by all recipients. [12] It is therefore recommended that women continue to adhere to cervical cancer screening procedures.[ citation needed ]

Adverse effects

In common with some other prefilled syringe vaccination products, the tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex sensitive individuals. [15] The vial stopper does not contain latex.

Ingredients

The active components of the vaccine are: [12] [16]

Biotechnology

Cervarix is created using the L1 protein of the viral capsid. 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 High Five Rix4446 cells derived from the insect Trichoplusia ni. The vaccine contains no live virus and no DNA, so it cannot infect the patient. [12]

History

The research findings that pioneered the development of the vaccine began in 1991 by The University of Queensland investigators Jian Zhou and Ian Frazer in Australia . Researchers at UQ found a way to form non-infectious virus-like particles (VLP), which could also strongly activate the immune system. Subsequently, the final form of 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. [17]

Clinical trials

Phase III trials have been conducted, including over 18,000 women from 14 countries in Asia-Pacific, Europe, Latin America and North America. [18]

As of 2009, the manufacturer was conducting a trial to compare the immunogenicity and safety of Cervarix with Gardasil. [19] Subsequent studies showed Cervarix generated higher antibody levels than Gardasil, the other commercially available HPV vaccine, upon testing seven months later, with twice the level for HPV type 16 and six times for HPV type 18. [20]

Society and culture

In the United Kingdom it was included in the national vaccination programme for teenage and pre-teenage girls aged 12–13 and 17–18 from September 2008 to August 2012. This caused some controversy since Cervarix was chosen over Gardasil, even though Gardasil protects against additional HPV types 6 and 11 (which cause genital warts). However, the efficacy of Cervarix is higher. [27]

Related Research Articles

<span class="mw-page-title-main">Wart</span> Small, rough growth resembling a cauliflower or a solid blister

Warts are non-cancerous viral growths usually occurring on the hands and feet but can also affect other locations, such as the genitals or face. One or many warts may appear. They are distinguished from cancerous tumors as they are caused by a viral infection, such as a human papillomavirus, rather than a cancerous growth.

<span class="mw-page-title-main">Cervical cancer</span> Cancer arising from the cervix

Cervical cancer is a cancer arising from the cervix. It is due to the abnormal growth of cells that have the ability to invade or spread to other parts of the body. Early on, typically no symptoms are seen. Later symptoms may include abnormal vaginal bleeding, pelvic pain or pain during sexual intercourse. While bleeding after sex may not be serious, it may also indicate the presence of cervical cancer.

<span class="mw-page-title-main">Human papillomavirus infection</span> Human disease

Human papillomavirus infection is caused by a DNA virus from the Papillomaviridae family. Many HPV infections cause no symptoms and 90% resolve spontaneously within two years. In some cases, an HPV infection persists and results in either warts or precancerous lesions. These lesions, depending on the site affected, increase the risk of cancer of the cervix, vulva, vagina, penis, anus, mouth, tonsils, or throat. Nearly all cervical cancer is due to HPV, and two strains – HPV16 and HPV18 – account for 70% of all cases. HPV16 is responsible for almost 90% of HPV-positive oropharyngeal cancers. Between 60% and 90% of the other cancers listed above are also linked to HPV. HPV6 and HPV11 are common causes of genital warts and laryngeal papillomatosis.

<span class="mw-page-title-main">Genital wart</span> Sexually transmitted infection caused by certain types of human papillomaviruses

Genital warts are a sexually transmitted infection caused by certain types of human papillomavirus (HPV). They may be flat or project out from the surface of the skin, and their color may vary; brownish, white, pale yellow, pinkish-red, or gray. There may be a few individual warts or several, either in a cluster or merged together to look cauliflower-shaped. They can be itchy and feel burning. Usually they cause few symptoms, but can occasionally be painful. Typically they appear one to eight months following exposure. Warts are the most easily recognized symptom of genital HPV infection.

<span class="mw-page-title-main">Anal cancer</span> Medical condition

Anal cancer is a cancer which arises from the anus, the distal opening of the gastrointestinal tract. Symptoms may include bleeding from the anus or a lump near the anus. Other symptoms may include pain, itchiness, or discharge from the anus. A change in bowel movements may also occur.

Virus-like particles (VLPs) are molecules that closely resemble viruses, but are non-infectious because they contain no viral genetic material. They can be naturally occurring or synthesized through the individual expression of viral structural proteins, which can then self assemble into the virus-like structure. Combinations of structural capsid proteins from different viruses can be used to create recombinant VLPs. Both in-vivo assembly and in-vitro assembly have been successfully shown to form virus-like particles. VLPs derived from the Hepatitis B virus (HBV) and composed of the small HBV derived surface antigen (HBsAg) were described in 1968 from patient sera. VLPs have been produced from components of a wide variety of virus families including Parvoviridae, Retroviridae, Flaviviridae, Paramyxoviridae and bacteriophages. VLPs can be produced in multiple cell culture systems including bacteria, mammalian cell lines, insect cell lines, yeast and plant cells.

<span class="mw-page-title-main">HPV vaccine</span> Class of vaccines against human papillomavirus

Human papillomavirus (HPV) vaccines are vaccines that prevent infection by certain types of human papillomavirus (HPV). Available HPV vaccines protect against either two, four, or nine types of HPV. All HPV vaccines protect against at least HPV types 16 and 18, which cause the greatest risk of cervical cancer. It is estimated that HPV vaccines may prevent 70% of cervical cancer, 80% of anal cancer, 60% of vaginal cancer, 40% of vulvar cancer, and show more than 90% efficacy in preventing HPV-positive oropharyngeal cancers. They additionally prevent some genital warts, with the quadrivalent and nonavalent vaccines that protect against HPV types HPV-6 and HPV-11 providing greater protection.

<span class="mw-page-title-main">Ian Frazer</span> Scottish-born Australian immunologist

Ian Hector Frazer is a Scottish-born Australian immunologist, the founding CEO and Director of Research of the Translational Research Institute (Australia). Frazer and Jian Zhou developed and patented the basic technology behind the HPV vaccine against cervical cancer at the University of Queensland. Researchers at the National Cancer Institute, Georgetown University, and University of Rochester also contributed to the further development of the cervical cancer vaccine in parallel.

<span class="mw-page-title-main">Gardasil</span> Human papillomavirus vaccine

Gardasil is an HPV vaccine for use in the prevention of certain strains of human papillomavirus (HPV). It was developed by Merck & Co. High-risk human papilloma virus (hr-HPV) genital infection is the most common sexually transmitted infection among women. The HPV strains that Gardasil protects against are sexually transmitted, specifically HPV types 6, 11, 16 and 18. HPV types 16 and 18 cause an estimated 70% of cervical cancers, and are responsible for most HPV-induced anal, vulvar, vaginal, and penile cancer cases. HPV types 6 and 11 cause an estimated 90% of genital warts cases. HPV type 16 is responsible for almost 90% of HPV-positive oropharyngeal cancers, and the prevalence is higher in males than females. Though Gardasil does not treat existing infection, vaccination is still recommended for HPV-positive individuals, as it may protect against one or more different strains of the disease.

<span class="mw-page-title-main">Bovine papillomavirus</span> Group of viruses

Bovine papillomaviruses (BPV) are a paraphyletic group of DNA viruses of the subfamily Firstpapillomavirinae of Papillomaviridae that are common in cattle. All BPVs have a circular double-stranded DNA genome. Infection causes warts of the skin and alimentary tract, and more rarely cancers of the alimentary tract and urinary bladder. They are also thought to cause the skin tumour equine sarcoid in horses and donkeys.

Margaret Anne Stanley, OBE FMedSc, is a British virologist and epithelial biologist. She attended the Universities of London, Bristol, and Adelaide. As of 2018, she is an Emeritus Professor of Epithelial Biology in the Department of Pathology at the University of Cambridge and a Fellow of the Academy of Medical Sciences. She is also an Honorary Fellow of the UK Royal College of Obstetricians and Gynaecologists and an honorary fellow of Christ's College, Cambridge. Stanley is a research scientist in virology focusing on the human papillomavirus (HPV). Her research work has led to new scientific findings on HPV. Additionally, she uses her expertise on HPV to serve on multiple advisory committees and journal editorial boards.

<span class="mw-page-title-main">Pandemrix</span> Flu vaccine

Pandemrix is an influenza vaccine for influenza pandemics, such as the 2009 flu pandemic. The vaccine was developed by GlaxoSmithKline (GSK) and patented in September 2006.

HspE7 is an investigational therapeutic vaccine candidate being developed by Nventa Biopharmaceuticals for the treatment of precancerous and cancerous lesions caused by the human papillomavirus (HPV). HspE7 uses recombinant DNA technology to covalently fuse a heat shock protein (Hsp) to a target antigen, thereby stimulating cellular immune system responses to specific diseases. HspE7 is a patented construct consisting of the HPV Type 16 E7 protein and heat shock protein 65 (Hsp65) and is currently the only candidate using Hsp technology to target the over 20 million Americans already infected with HPV.

A subunit vaccine is a vaccine that contains purified parts of the pathogen that are antigenic, or necessary to elicit a protective immune response. Subunit vaccine can be made from dissembled viral particles in cell culture or recombinant DNA expression, in which case it is a recombinant subunit vaccine.

Adjuvant System 04 or AS04 is a trade name for a combination of adjuvants used in various vaccine products by GlaxoSmithKline, in particular the Fendrix hepatitis B vaccine and Cervarix human papillomavirus (HPV) vaccine. It consists of aluminium hydroxide and monophosphoryl lipid A (MPL). It is the successor of AS03, a squalene based adjuvant used in H1N1/09 and H5N1 influenza vaccines.

Jian Zhou was a Chinese virologist and cancer researcher, who with fellow researcher Ian Frazer, invented Gardasil and Cervarix, the vaccines for stimulating human immunological resistance to the cervical cancer-inducing human papilloma virus.

Diane Medved Harper is a professor in the Department of Family Medicine at the University of Michigan. Her area of expertise is human papillomavirus (HPV) and the diseases associated with it, as well as colposcopy, and she was one of the investigators in the clinical trials of Gardasil and Cervarix, vaccines against HPV.

Human papillomavirus (HPV)-associated oropharyngeal cancer awareness and prevention is a vital concept from a public and community health perspective.

<span class="mw-page-title-main">HPV Prevention and Control Board</span>

The HPV Prevention and Control Board, founded in 2015, is an independent group of international experts supported by unrestricted grants from the pharmaceutical industry that bring together key professionals, groups and government officials to deal with issues related to screening and prevention programmes for human papillomavirus (HPV) infection, the persistence of which may lead to cervical cancer, the second most common cancer in women living in low-resource settings. The Board focusses on preventing cervical cancer in these countries by promoting the sharing of information on cervical screening and HPV vaccination, which by 2014 had reached only around 3% of eligible girls in low income countries.

References

  1. ↑ "CERVARIX human papillomavirus vaccine types 16 and 18 [recombinant, AS04 adjuvanted] suspension for injection vial (126115)". department of Health and Aged Care.
  2. ↑ "Archived copy" (PDF). Archived (PDF) from the original on 1 May 2022. Retrieved 10 October 2022.{{cite web}}: CS1 maint: archived copy as title (link)
  3. ↑ "Cervarix". U.S. Food and Drug Administration (FDA). 4 October 2022. STN:BL 125259. Archived from the original on 10 October 2022. Retrieved 9 October 2022.
  4. ↑ "Cervarix". U.S. Food and Drug Administration (FDA). 16 October 2009. Archived from the original on 22 July 2017. Retrieved 9 October 2022.
  5. ↑ "Cervarix EPAR". European Medicines Agency (EMA). Archived from the original on 5 June 2022. Retrieved 9 October 2022.
  6. 1 2 3 4 Centers for Disease Control and Prevention (CDC) (May 2010). "FDA licensure of bivalent human papillomavirus vaccine (HPV2, Cervarix) for use in females and updated HPV vaccination recommendations from the Advisory Committee on Immunization Practices (ACIP)". MMWR. Morbidity and Mortality Weekly Report. 59 (20): 626–629. PMID   20508593. Archived from the original on 3 August 2017. Retrieved 9 September 2017.
  7. ↑ "New data show Cervarix, GSK'S HPV 16/18 cervical cancer candidate vaccine, is highly immunogenic and well-tolerated in women over 25 years of age". GlaxoSmithKline. 5 June 2006. Archived from the original on 27 September 2007. Retrieved 27 January 2007.
  8. ↑ "Cervical Cancer Vaccines: Cervarix". Emory University. 21 August 2006. Archived from the original on 9 October 2006. Retrieved 27 January 2007.
  9. ↑ "GSK exits U.S. market with its HPV vaccine Cervarix". FiercePharma. 21 October 2016. Archived from the original on 9 July 2021. Retrieved 6 July 2021.
  10. ↑ Harper, D. (2009). "Current prophylactic HPV vaccines and gynecologic premalignancies". Current Opinion in Obstetrics and Gynecology. 21 (6): 457–464. doi:10.1097/GCO.0b013e328332c910. PMID   19923989. S2CID   24765340.
  11. ↑ Marcia G. Yerman (28 December 2010). "An Interview with Dr. Diane M. Harper, HPV Expert". The Huffington Post . Archived from the original on 27 July 2018. Retrieved 12 January 2010.
  12. 1 2 3 4 5 6 "Cervarix Prescribing Information" (PDF). Food and Drug Administration . Archived (PDF) from the original on 23 November 2010. Retrieved 3 August 2010.
  13. 1 2 Glaxo cervical cancer shot approved in Australia Archived 4 May 2021 at the Wayback Machine Reuters (21 May 2007) Retrieved on 25 May 2007
  14. ↑ Schwarz, T. F. (2009). "Clinical update of the AS04-Adjuvanted human Papillomavirus-16/18 cervical cancer vaccine, cervarix®". Advances in Therapy. 26 (11): 983–998. doi:10.1007/s12325-009-0079-5. PMID   20024678. S2CID   44625098.
  15. ↑ "Latex in Vaccine Packaging" (PDF). Centers for Disease Control and Prevention (CDC). May 2010. Archived (PDF) from the original on 13 April 2010. Retrieved 11 August 2010.
  16. ↑ http://emc.medicines.org.uk/medicine/20207/PIL/Cervarix/ Archived 7 March 2010 at the Wayback Machine Patient Information Leaflet
  17. ↑ McNeil, C. (2006). "Who invented the VLP cervical cancer vaccines?". J Natl Cancer Inst. 98 (7): 433. doi: 10.1093/jnci/djj144 . PMID   16595773.
  18. ↑ Paavonen J, Naud P, Salmerón J, et al. (July 2009). "Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women". Lancet. 374 (9686): 301–14. doi:10.1016/S0140-6736(09)61248-4. PMID   19586656. S2CID   1331989.
  19. ↑ Einstein MH, Baron M, Levin MJ, et al. (October 2009). "Comparison of the immunogenicity and safety of Cervarix and Gardasil human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18-45 years" (PDF). Hum Vaccin. 5 (10): 705–19. doi: 10.4161/hv.5.10.9518 . PMID   19684472. S2CID   23610327. Archived (PDF) from the original on 1 August 2014. Retrieved 28 November 2010.
  20. ↑ "CERVARIX". RxList. Archived from the original on 10 July 2021. Retrieved 10 July 2021.
  21. ↑ "Vaccine vs cervical cancer virus launched in Manila". GMA Network . Associated Press. 25 August 2007. Archived from the original on 27 August 2007. Retrieved 25 August 2007.
  22. ↑ "Glaxo prepares to launch Cervarix after EU okay". Reuters. 24 September 2007. Archived from the original on 25 October 2008. Retrieved 18 July 2008.
  23. ↑ "FDA approves Cervarix, GlaxoSmithKline's cervical cancer vaccine" (Press release). GlaxoSmithKline. 16 October 2009. Archived from the original on 19 October 2009. Retrieved 30 October 2009.
  24. ↑ "October 16, 2009 Approval Letter - Cervarix". U.S. Food and Drug Administration (FDA). 16 October 2009. Archived from the original on 19 October 2009. Retrieved 13 November 2009.
  25. ↑ "Cervarix - Glaxo HPV Vaccine Filed With FDA". Vaccine Rx. 29 March 2007. Archived from the original on 28 September 2007. Retrieved 30 March 2007.
  26. ↑ "GSK Does Not Expect FDA Approval Of HPV Vaccine Cervarix Until End Of 2009". Archived from the original on 29 August 2008. Retrieved 18 July 2008.
  27. ↑ Hawkes, Nigel (18 July 2008). "Anger over Department of Health choice of cheaper cancer vaccine". The Times . London. Archived from the original on 18 September 2011. Retrieved 18 July 2008.

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