Cervarix, 0.5 ml

Cervarix is a recombinant adsorbed vaccine for the prevention of diseases caused by human papillomaviruses (HPV) containing adjuvant AS04. It is a mixture of virus-like particles of recombinant surface proteins of HPV types 16 and 18, the action of which is enhanced by the AS04 adjuvant system.

The L1 proteins of HPV-16 and HPV-18 were obtained using recombinant baculoviruses HPV-16 and HPV-18 on Trichoplusia ni cell culture (Hi-5 Rix4446). AS04 consists of aluminum hydroxide and 3-O-desacyl-4′-monophosphorylipid A (MFL).

According to epidemiological data, most cases of cervical cancer are caused by oncogenic human papillomaviruses. HPV-16 and HPV-18 are responsible for more than 70% of cervical cancers and about 50% of all cases of cervical intraepithelial lesions worldwide.

Vaccine immunogenicity
A full course of vaccination (0-1-6 months) resulted in specific antibodies against HPV-16 and HPV-18 determined in 100% of those vaccinated 18 months after the last dose of vaccine in age groups ranging from 10 to 25 years.

The maximum expression of the immune response was observed immediately after completion of the vaccination course (7th month). Antibodies persisted for 4 years of follow-up after the first dose.

In addition, the neutralizing ability of the antibodies produced was proven.

All initially seronegative women, including the 46-55 age group, became seropositive at completion of the vaccination course (7th month); antibody levels at 7th month were at least 3-4 times higher than those observed in efficacy studies at 18 months post-vaccination. Protective antibody levels were observed at 18 months and were maintained at the same level during the four-year follow-up period, with no subsequent decline.

In women initially seropositive for HPV-16 and/or HPV-18, Cervarix induced the same level of antibody production as in initially seronegative women, with antibody titers significantly higher than those produced after infection./p>

The adjuvant system AS04 induces a longer immune response than that using aluminum salts as an adjuvant. Antibody titers with AS04 were at least twice as high for 4 years after the first dose, and memory B-lymphocyte counts were about twice as high for 2 years after the first dose.

Indications

Composition

How to take, the dosage

Cervarix® is administered by injection into the deltoid region. Cervarix® should never be given intravenously or intradermally.

Before use, the vaccine should be checked visually for foreign particles and the syringe or vial should be shaken well to produce an opaque, whitish suspension. If the vaccine is not as described, or contains foreign particles, it should be destroyed.

Vaccination Schedules

The recommended single dose for girls over 10 years of age and women is 0.5 ml.

The primary immunization regimen involves administering three doses of vaccine in a 0-1-6 month schedule.

The need for revaccination has not been determined at this time.

Interaction

There are no data on interactions between Cervarix and other vaccines when used concomitantly.

In clinical trials, approximately 60% of women who received Cervarix® vaccine were found to use oral contraceptives. There are no data on adverse effects of contraceptives on the efficacy of Cervarix® vaccine.

It has been suggested that an adequate immune response may not be achieved in patients receiving immunosuppressants.

Special Instructions

Cervarix should be used with caution in thrombocytopenia or disorders of the clotting system, as bleeding may occur during the intravenous administration.

There are currently no data on the possibility of Cervarix infusion by injection.

It is unlikely that Cervarix can cause regression of lesions and also prevent progression of disease caused by HPV-16 and/or HPV-18 present prior to vaccination, and therefore vaccine use for this purpose is not indicated. Clinical data demonstrate that Cervarix is safe and immunogenic when administered to individuals who are seropositive for HPV-16 and/or HPV-18 types with no evidence of intraepithelial lesions or only atypical squamous cells of unclear significance (ASC-US) on cytological examination.

The vaccine does not prevent infection or disease from certain types of HPV.

The vaccine is the primary prevention method and does not replace the need for regular checkups with your doctor (secondary prevention).

Because of the possibility in rare cases of anaphylactic reactions, vaccinated patients must be under medical supervision for 30 minutes and the procedure rooms must be provided with antishock therapy.

In patients with immunodeficiency conditions, such as HIV infection, an adequate immune response may not be achieved.

Contraindications

Hypersensitivity to any component of the vaccine;
Hypersensitivity reactions to previous administration of Cervarix.

The administration of Cervarix should be delayed in persons with acute febrile conditions, including exacerbations of chronic diseases.

Side effects

In controlled trials of Cervarix vaccine, pain at the injection site was the most common.

CNS disorders: very often – headache, feeling of fatigue; sometimes – dizziness.

The digestive system: often – nausea, vomiting, diarrhea, abdominal pain.

Skin and its appendages: often – itching, rash, urticaria.

Muscular system and connective tissue: very common – myalgia; common – arthralgia; rarely – muscle weakness.

Infectious complications: sometimes – infections of the upper respiratory tract.

Body overall and related to the site of administration: very often – feeling of fatigue, local reactions including pain, redness, swelling; often – fever (above 38°C); sometimes – other reactions at the site of administration, including thickening, decreased local sensitivity, itching.

Overdose