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Home » Drug Information » FDA Approved Drugs » 2009
Medical Areas: Immunology | Obstetrics/Gynecology (Women’s Health) | Oncology | Family Medicine

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Cervarix [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: GlaxoSmithKline
Approval Status: Approved October 2009
Treatment Area: prevention of cervical cancer and cervical intraepithelial neoplasia caused by HPV types 16 and 18

General Information

Cervarix is a virus-like particle combination vaccine consisting of self-assembling, virus-like particles based on HPV-16 and HPV-18. It was designed to elicit an immune response against the human papilloma virus (HPV).

Cervarix is specifically indicated for the prevention of the following diseases caused by oncogenic human papillomavirus (HPV) types 16 and 18: cervical cancer, cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ and CI) grade 1 in females 10 through 25 years of age.

Cervarix is supplied as a suspension for intramuscular injection. The recommended administration is 3 doses of 0.5-mL each, by intramuscular injection at 0, 1, and 6 months.

Clinical Results

FDA Approval
The FDA approval of Cervarix was based on two double-blind, randomized, controlled clinical studies that enrolled a total of 19,778 females 15 through 25 years of age.
Study One (HPV001)
This study enrolled women who were negative for oncogenic HPV DNA in cervical samples, seronegative for HPV-16 and HPV-18 antibodies and had normal cytology. This population was presumed "naïve" without current HPV infection at the time of vaccination and without prior exposure to either HPV-16 or HPV-18. Twelve-month persistent infection was evaluated as an efficacy endpoint. There were five cases of 12-month persistent HPV-16/18 infection (4 HPV-16; 1 HPV-18) in the control group and one HPV-16 case in the vaccine group in study 001.
Study Two (HPV008)
In this study women were vaccinated regardless of baseline HPV DNA status, serostatus or cytology. This population was naïve (without current infection and without prior exposure) or non-naïve (with current infection and/or with prior exposure) to HPV. Cervarix provided a high and statistically significant level of efficacy against pre-cancerous lesions associated with each of the HPV types included in the vaccine (HPV 16 and HPV 18). In addition, the data demonstrated that the vaccine also provided type-specific protection against pre-cancerous lesions associated with some additional common cancer-causing HPV types other than HPV 16 and HPV 18. In women without evidence of prior cancer-causing HPV infection the overall efficacy demonstrated against any lesion, regardless of HPV type, was much greater than would be expected for a vaccine targeting only HPV types 16 and 18.

Study 1 and Study 1 Extension
In Study 1 and Study 1 Extension, with up to 6.4 years of follow-up (mean 5.9 years), in naïve females 15 through 25 years of age, efficacy against CIN2/3 or AIS associated with HPV-16 or HPV-18 was 100%. Efficacy against 12-month persistent infection with HPV-16 or HPV-18 was 100%.

Side Effects

Adverse events associated with the use if Cervarix may include, but are not limited to, the following:

  • Pain
  • Redness
  • Swelling at the injection site
  • Fatigue
  • Headache
  • Myalgia
  • Gastrointestinal symptoms
  • Arthralgia

Mechanism of Action

Cervarix is a non-infectious recombinant, AS04-adjuvanted vaccine that contains recombinant L1 protein, the major antigenic protein of the capsid, of oncogenic HPV types 16 and 18. It is thought that the efficacy of the vaccine may be mediated by the development of IgG neutralizing antibodies directed against HPV-L1 capsid proteins generated as a result of vaccination.

Literature References

Paavonen J, Naud P, Salmerón J, Wheeler CM, Chow SN, Apter D, Kitchener H, Castellsague X, Teixeira JC, Skinner SR, Hedrick J, Jaisamrarn U, Limson G, Garland S, Szarewski A, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, Bosch FX, Jenkins D, Hardt K, Zahaf T, Descamps D, Struyf F, Lehtinen M, Dubin G; HPV PATRICIA Study Group, Greenacre M 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. The Lancet Jul 25;374(9686):301-14

Descamps D, Hardt K, Spiessens B, Izurieta P, Verstraeten T, Breuer T, Dubin G Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Human Vaccines 2009 May;5(5):332-40. Epub 2009 May 20

Additional Information

For additional information regarding Cervarix or the prevention of cervical cancer and cervical intraepithelial neoplasia caused by HPV types 16 and 18, please visit the Cervarix web page.