> Guardasil: the vaccine against the Papilloma virus – HPV

this document is the synthesis of an assessment report the european public (EPAR). The EPAR illustrate the way in which the committee for medicinal products for human use (CHMP), based on the examination of existing studies, è joint recommendations on the conditions of use of a medicinal product. For more information about their diseases or medical this therapy, please read the package leaflet (attached to the EPAR) or consult your doctor or pharmacist. For more information based on the recommendations of the CHMP, please, read the scientific discussion (also attached to the EPAR). 

Che cos’è Gardasil?

Gardasil is a vaccine. This is an injectable suspension containing the L1 proteins purified to 4 types of human papillomavirus (types 6, 11, 16, and 18).

what do you use Gardasil?

Gardasil is used as the vaccine against the diseases caused by the human papillomavirus (HPV), of type 6, 11, 16 and 18. Gardasil is indicated for the protection against high-grade dysplasia (growth of abnormal cells type pretumorale) high-grade neck of the uterus or the vulva, carcinoma of the cervix and condyloma (genital warts) caused by these HPV-infections.

The efficacy of Gardasil has been studied in adult women of age between 16 and 26 years, while his immunogenicità (in other words, its capacity to induce the body’s immune response to the viral infection) has been studied in children and adolescents (età between 9 and 15 years. The protective efficacy of the vaccine has been studied in males.

Gardasil is administered in accordance with official recommendations. The medicine può be obtained only with a prescription.

Come si usa Gardasil?

Gardasil is administered to patients 9 years of age; or più, in three doses, leaving an interval of 2 months between the first and second dose and an interval of 4 months between the second and third dose. In the case where it is necessary to a vaccination program alternative, the second dose must be administered at least 1 month after the first dose, and third dose at least 3 months after the second dose.

All three doses must be administered within the 1-year period. The vaccine is administered by intramuscular injection (injection practiced in the thickness of the muscle), preferably in the arm or in the thigh.

Come agisce Gardasil?

papillomaviruses are viruses that cause warts and abnormal growth of the tissues. There are over 100 types of papillomavirus, some of which are associated with malignant tumors of the genitals. HPV types 16 and 18 are responsible for approximately 70% of carcinoma of the cervix, while HPV types 6 and 11 cause approximately 90% of cases of condyloma (genital warts).

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All papillomaviruses have a shell, or “capsid”, made up of proteins (protein L1). Gardasil contains L1 proteins purified for 4 types of human papillomavirus (types 6, 11, 16, and 18). The proteins contained in the vaccine are produced with a method known as “recombinant DNA technology”, are that is obtained from a yeast in which is inserted a gene (DNA) that makes it able to produce the L1 proteins.

They are assembled into “virus-like particles’ (i.e. structures that resemble the HPV virus so that the body has difficultyà to recognize them). In addition, the vaccine contains an “adjuvant” (a compound containing aluminium) to stimulate a better response.

When a patient receives the vaccine, the immune system (that fights diseases) makes antibodies against these proteins. The antibodies help to neutralize the virus. In the case of exposure to the virus following vaccination, the immune system will be able to produce antibodies more quickly. The body will be then able to protect themselves from diseases caused by these viruses.

What studies have been done on Gardasil?

The effects of Gardasil were tested in experimental models before being studied in humans. The four main studies have been conducted on over 20 000 women of age between 16 and 26 years old. Gardasil has been compared with a placebo vaccine, dummy). The studies examined the number of women who developed genital warts, genital lesions or growth of abnormal cells that are related to infections by HPV. The women participating in the study were then monitored for 2-4 years.

What benefits have shown Gardasil in the course of studies?

Gardasil is proven to be effective in the prevention of dysplasia of the cervix and external genital warts related to HPV 6, 11, 16 and 18. Taking into consideration the results of all four studies together, among women who in the past had ever contracted an infection from HPV 6, 11, 16 and 18 and which are subject to the entire program of vaccination, no patient treated with Gardasil (8 487 women) has developed dysplastic lesions to high-grade cervical caused by HPV 16 or 18, whereas 53 of the 8 460 women è was administered a placebo as a vaccine have reported injuries of this kind.

with regards To the warts caused by HPV 6, 11, 16 or 18, and examining the overall results of the three studies, this condition has been observed in 1 patient in the group vaccinated with Gardasil (7 897 women) and in 91 patients in the placebo group (7 899 women).

What are the risks associated with Gardasil?

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The side effects observed more frequently in the studies (in more than 1 patient in 10) are pyrexia (fever) and reactions at the point of injection (redness, pain, swelling). For the complete list of all side effects reported with Gardasil, please see the package leaflet.

Gardasil should not be administered to subjects who may be hypersensitive (allergic) to the active substance or to any of the other ingredients. If a patient shows signs of an allergy after administration of a dose of Gardasil, the administration of the other doses of the vaccine must be stopped. The vaccination should be postponed in patients who have a disease with a high fever.

Perchè è stato approvato Gardasil?

The committee for medicinal products for human use (CHMP) decided that the benefits of Gardasil outweigh the risks in the vaccination aimed to prevent lesions (CIN 2/3) and cancer of the neck of the uterus, lesions of the vulva (VIN 2/3) and external genital (condyloma acuminata) caused by HPV 6, 11, 16 and 18, and has therefore recommended the granting of the marketing authorisation.

Other information about Gardasil:

The 20 September 2006, the european Commission has released to Sanofi Pasteur MSD SNC, a marketing authorisation for Gardasil, valid throughout the european Union.

the Last update of this summary: 09-2006

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