Manufacturer:

GlaxoSmithKline Pharmaceuticals

Pharmacological Class:

Vaccine (HPV)

Active Ingredient(s):

Bivalent human papillomavirus (HPV) vaccine types 16 and 18 vaccine; recombinant; aluminum adsorbed; suspension for IM injection; preservative-free.

Indication(s):

In females 10–25 years old, to prevent cervical cancer, cervical intraepithelial neoplasia (CIN) grade 1, grade 2 or worse and adenocarcinoma in situ, (AIS), caused by HPV types 16 and 18.

Pharmacology:

Cervarix is a non-infectious vaccine that contains recombinant L1 protein, the major antigenic protein of the capsid (virus), of oncogenic HPV types 16 and 18.

Clinical Trials:

Two trials were conducted to assess the efficacy of Cervarix in preventing CIN2/3 or AIS in 19,778 females 15–25 years of age. The first study enrolled subjects who were negative for oncogenic HPV DNA (including types 16 and 18 and 12 other types) in cervical samples, seronegative for HPV-16 and HPV-18, and had normal cytology. A follow-up study for Study 1 was begun to assess the vaccine's long-term efficacy, safety, and immunogenicity. In both this study and the extension (with up to 6.4 years follow-up [mean 5.9 years]), efficacy against CIN2/3 or AIS associated with HPV-16 or HPV-18 was 100%.

In Study 2, subjects were vaccinated with Cervarix regardless of their baseline HPV DNA status, serostatus, or cytology. Before vaccination, cervical samples were assessed for oncogenic HPV DNA and serostatus of HPV-16 and HPV-18 antibodies. Efficacy analyses included lesions arising among women regardless of baseline DNA status and serostatus. In this population (naive and non-naive women), Cervarix was effective in the prevention of precancerous lesions or AIS associated with HPV-16 or HPV-18. Among women who were HPV DNA positive regardless of serostatus at baseline, efficacy was not demonstrated against precancerous lesions or AIS associated with HPV-16 or HPV-18. In the population naive to oncogenic HPV, Cervarix reduced the overall incidence of CIN1/2/3 or AIS, CIN2/3 or AIS, and CIN3 or AIS regardless of the HPV DNA type in the lesion. In the naive and non-naive group, the vaccine was shown to be effective against CIN1/2/3 or AIS, CIN2/3 or AIS, and CIN3 or AIS in all women regardless of HPV DNA type in the lesion.

The efficacy of Cervarix in girls 10–14 years of age is inferred based on immunogenicity data obtained from Studies 3 and 4. Study 3 compared the immunogenicity of Cervarix to Hepatitis A vaccine. All initially seronegative subjects given the 3-dose course of Cervarix for whom assay results were available converted to seropositive for HPV-16 and HPV-18. In Study 4, the immunogenicity of Cervarix in girls 10–14 years old was compared to that in females 15–25 years old. Measured 1 month after dose 3, the immune responses in the younger group were non-inferior to those of the older group.

Legal Classification:

Rx

Adults & Children:

Give by IM inj in deltoid. Each dose is 0.5mL. <10 years: not recommended. Females 10–25 years: Give 1^st dose at elected date, 2^nd dose 1 month after 1^st dose, 3^rd dose 6 months after 1^st dose. Monitor 15 minutes post-dose.

Warnings/Precautions:

Not a substitute for routine cervical screening. Immunosuppressed. Latex allergy (prefilled syringes). Pregnancy (Cat.B): not recommended. Nursing mothers.

Interaction(s):

Immunosuppressants: may get suboptimal response.

Adverse Reaction(s):

Injection site reactions, fatigue, headache, myalgia, GI upset, arthralgia, syncope (transient tonic-clonic movements, other seizure-like activity possible post-dose).

How Supplied:

Single-dose vial—10
Prefilled syr—1, 5

美国FDA核准Cervarix的用于子宫颈癌预防