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Vaccine Detail

Gardasil
Vaccine Information
  • Product Name: Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
  • Tradename: Gardasil
  • Manufacturer: Merck & Co., Inc.
  • Vaccine Ontology ID: VO_0000049
  • CDC CVX code: 62
  • Type: Subunit vaccine
  • Status: Licensed
  • Location Licensed: USA (License #0002)
  • Host Species for Licensed Use: Human
  • Antigen: Virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, and 18.
  • Adjuvant: amorphous aluminum hydroxyphosphate sulfate adjuvant (AAHSA)
  • Preparation: GARDASIL is a non-infectious recombinant quadrivalent vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, and 18. The L1 proteins are produced by separate fermentations in recombinant Saccharomyces cerevisiae and self-assembled into VLPs. The fermentation process involves growth of S. cerevisiae on chemically-defined fermentation media which include vitamins, amino acids, mineral salts, and carbohydrates. The VLPs are released from the yeast cells by cell disruption and purified by a series of chemical and physical methods. The purified VLPs are adsorbed on preformed aluminum-containing adjuvant (Amorphous Aluminum Hydroxyphosphate Sulfate). The quadrivalent HPV VLP vaccine is a sterile liquid suspension that is prepared by combining the adsorbed VLPs of each HPV type and additional amounts of the aluminum-containing adjuvant and the final purification buffer. GARDASIL is a sterile suspension for intramuscular administration (FDA: Gardasil).
  • Immunization Route: Intramuscular injection (i.m.)
  • Storage: GARDASIL should be refrigerated at 2 to 8 degrees Celcius. Do not freeze. Protect from light.
  • Approved Age for Licensed Use: Females ages 9-26
  • Contraindication: Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL.
  • Description: Indication: Vaccination in females 9 to 26 years of age for prevention of the following diseases caused by Human Papillomavirus (HPV) Types 6, 11, 16, and 18: cervical cancer, and genital warts (condyloma acuminata), and the following precancerous or dysplastic lesions: cervical adenocarcinoma in situ (AIS), cervical intraepithelial neoplasia (CIN) grade 2 and grade 3, vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3, vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3, cervical intraepithelial neoplasia (CIN) grade 1 (FDA: Gardasil). In June 2006, the US Food and Drug Administration licensed this first vaccine to prevent cervical cancers and other diseases in women. This quadrivalent vaccine protects against HPV-6, HPV-11, HPV-16, and HPV-18, which are responsible for 70% of cervical cancers and 90% of genital warts (Huang, 2008).
Host Response

Human Response

  • Vaccination Protocol: In 5 clinical trials, subjects were administered with GARDASIL or AAHS (Amorphous Aluminum Hydroxyphosphate) control or saline placebo. The subjects included 5088 girls and women ages 9 to 26 years (FDA: Gardasil).
  • Immune Response: In clinical studies it was discovered that around 99% of girls and women who were immunized with GARDASIL became anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive by 1 month after the third and final dose(FDA: Gardasil).
  • Side Effects: Most common side effect of immunization was headache. Other side effects include: fever, nausea, dizziness, injection site pain and swelling.
References
FDA: Gardasil: FDA: Gardasil information [http://www.fda.gov/Cber/products/gardasil.htm]
Huang, 2008: Huang CM. Human papillomavirus and vaccination. Mayo Clinic proceedings. Mayo Clinic. 2008; 83(6); 701-706; quiz 706-706. [PubMed: 18533087].