Preparation: to lay down-prof. Contains AG. It is a purified lyophilized polysaccharides of Neisseria menengitis serogroup A. Single vaccination starting from the age of 18 months in 1 dose, regardless of age. The vaccine is administered s / c or / m. Children under the age of 18 months are not subject to vaccination, excluding epidemic situations, because. on component A of the vaccine, immunity can develop already from 3 months, and on component C, it practically does not develop. In accordance with the labeling on the package, the shelf life of the vaccine when stored at temperatures from +2 degrees C to +8 degrees C in lyophilized form is 3 years . Immunity: active, arts, potsvaccines.

18. Staphylococcal therapeutic liquid vaccine (staphylococcal antifagin)

Preparation: to lay down-prof. Contains: AG. It is a complex of thermostable antigens extracted from staphylococcus microbial cells by water-phenol extraction. PC, on the shoulder orsubscapular region.

The course of treatment for adults and children from 7 years of age consists of single daily injections according to the following scheme: 1st day - 0.2 ml, 2nd - 0.3 ml, 3rd - 0.4 ml, 4th - 0.5 ml, 5th - 0.6 ml, 6th - 0.7 ml, 7th - 0.8 ml, 8th - 0.9 ml, 9th - 1 ml.

For children from 6 months to 7 years, the dose at the first injection is 0.1 ml. In the absence of a reaction, the drug is administered daily according to the indicated scheme, successively increasing each dose by 0.1 ml (0.2 ml for the second injection, 0.3 ml for the third, etc.). Each subsequent dose of the drug is administered at a distance of 20–30 mm from the site of previous injections or into the opposite arm.

With widespread skin lesions that occur with relapses, it is advisable to repeat the course of treatment according to the same scheme after 10–15 days.

In a dry place, at a temperature of 2-10 °C.

Keep out of the reach of children.

Immunity: active, arts, potsvaccines, antibacterial.

19. Leptospirosis vaccine

Preparation: to lay down-prof. Contains: AG. It is a mixture of heat-inactivated leptospira cultures, preservative phenol. Side effects: Leptospirosis vaccine is one of the drugs with low reactogenicity. Rarely (on the first day after administration) - local reaction (hyperemia, infiltrate up to 30 mm in diameter), subfebrile temperature. Dosage and administration:

P / c in the region of the lower angle of the scapula. Vaccination is carried out once at a dose of 0.5 ml. Revaccination is carried out after 1 year, a single dose of 0.5 ml. Shake the ampoule thoroughly before administration. . Unsuitable for use are preparations with impaired integrity of the ampoules or lack of labeling, with a change in physical properties (color, transparency, presence of flakes), with an expired shelf life and with improper storage. The opening of the ampoules and the procedure for administering the vaccine is carried out under strict observance of the rules of asepsis. The drug in the opened ampoule is not subject to storage. Immunity: active, arts, potsvaccines, specific.

20. Inactivated culture vaccine against tick-borne encephalitis

Preparation: to lay down-prof. Contains: AG. It is a sterile suspension of formalin-inactivated tick-borne encephalitis virus, obtained by reproducing it in a suspension of chicken embryo cells, absorbed on an adjuvant. In / m into the deltoid muscle in a single dose of 0.5 ml.The primary course of vaccination is carried out according to 2 schemes:1st scheme: 1st vaccination - on the selected day, 2nd - after 1-2 months, 3rd - after 12 months.2nd scheme: 1st vaccination - on the selected day, 2nd - after 5-7 months, 3rd - after 12 months.Subsequent remote revaccinations are carried out once every three years.Storage: In accordance with SP 3.3.2.1248-03 at temperatures from 2 to 8 0 FROM.Do not freeze .

Transportation: In accordance with SP 3.3.2.1248-03 at temperatures from 2 to 8 0 FROM.Do not freeze. Transportation is allowed at temperatures from 9 to 25 0 C within 2 days. For long distances - only by air.

Leave conditions:For treatment-and-prophylactic and sanitary-prophylactic institutions.

Shelf life: 3 years.

. Immunity: active, arts, potsvaccines, antiviral.

Meningococcal infection is a disease that carries a great danger for the children's age group. The disease is associated with a high rate of mortality and neurological disorders. Meningococcal infection is characterized by intense headaches, photophobia, vomiting, and meningeal syndrome. Immunoprophylaxis has been developed to fight infection. One of them is the meningococcal group A dry polysaccharide vaccine for the prevention of meningococcal infection (serogroup A) in children and adults.

Meningococcal group A vaccine for the prevention of meningococcal infection: composition and formulation

The vaccine against meningococcal infection is produced in Russia. The active substance of the drug is presented in the form of a lyophilisate. It comes with isotonic sodium chloride solution in a volume of 5 ml.

The composition of the drug:

• Capsular antigen of meningococcus (polysaccharide) at a dosage of 250 mcg.
• 10 mg lactose monohydrate.

Externally, the drug has a whitish color, loose in consistency. Packing form - cardboard boxes.

Pharmacological action of the vaccine

The vaccine for immunoprophylaxis of meningococcal infection works similarly to other drugs in this group. Vaccination has several goals:

• Development of a pool of specific immunoglobulins.
• Creation of immunological memory.

The vaccine contains a polysaccharide - the protein of the meningococcus capsule. It is a foreign body for the human body (pathogen). It is the protein that initiates the immune response after the administration of the drug. Vaccination programs the immune system to remember the specific pathogen that causes the disease. After the introduction of the vaccine, a primary response occurs, as a result of which the recognition of the antigen occurs. Then the humoral link of the immune system is activated. Special cells B-lymphocytes turn into plasma cells. The latter produce immunoglobulins. They neutralize the pathogen. Acquired specific immunity is formed.

When a person re-encounters with an already real pathogen, the processes of immunological memory are included in the work. A secondary immune response occurs. As a result, the fight against infection is much faster and more intense. This allows you to quickly overcome pathogens and prevent the development of a detailed clinical picture of the disease.

Important! After vaccination, specific immunity against meningococcal infection persists for three years.

Indications and preparation for the administration of the meningococcal vaccine

Vaccination against meningococcal infection is carried out for a certain contingent of the population. The first of them - children of the first year of life. The purpose of vaccination is to prevent generalized forms of infection. The second group is people who had contact with a patient with meningococcal infection. In this case, vaccination is indicated according to epidemiological indications. Vaccination is also carried out in regions with an increased incidence of this disease. In the event of an outbreak of infection among the population, it is recommended that at least 85% of the population be vaccinated.

Immunoprophylaxis requires some preliminary preparation. Mothers of young children are advised to adhere to the following rules:

• Do not feed your baby 1-2 hours before vaccination.
• Before performing the procedure, it is necessary that the child sleep well.
• Clothing should be comfortable and easily removable.
• You don't need to wrap your child too much. Severe sweating leads to fluid loss in the body, which increases the risk of post-vaccination reactions.

Older children should be told about the vaccination procedure and why it is necessary. Before vaccination, a visit to the doctor is recommended to determine the current state of health. The specialist must be informed about the presence of allergic reactions, post-vaccination complications, if any.

Method of application of the drug and dose

The drug is used only by subcutaneous method. Preferred injection sites are the subscapular region or the upper third of the upper arm. One ampoule with the active substance is designed for five doses for patients nine years of age and older and ten doses for children from one to eight years of age. Before the procedure, the health worker without fail takes the temperature of the patient. In addition, he will check the characteristics of the vaccine. Namely: the expiration date, the integrity of the package, the presence of labeling, consistency, color, the presence of pathological components. Then proceed to the injection.

This procedure is performed under strict aseptic and antiseptic conditions. This means that the health worker must use a disposable syringe and gloves. The injection site is treated with an antiseptic solution. Usually, a solution of ethyl alcohol is used for this purpose. After the administration of the drug, the patient should be under medical supervision for some time. In very rare cases, after immunoprophylaxis, allergic reactions of the immediate type occur. They pose a great danger to the health of the patient. That is why you can not leave the medical institution immediately after vaccination.

Contraindications for the introduction of the vaccine

Despite the fact that the meningococcal vaccine is a fairly safe drug, it cannot be used by certain categories of the population. Vaccination against meningococcus is contraindicated:

• Persons who have had a history of post-vaccination reactions or complications to this drug.
• Patients suffering from acute inflammatory or infectious diseases.
• People with chronic pathology in the stage of decompensation.
• People with cancer, leukemia, lymphomas, etc.
• Pregnant and lactating mothers.
• Patients with individual lactose intolerance.

The use of the vaccine against the background of taking other immunomodulating agents is possible only after consulting a doctor. There is a risk that specific immunity is not formed or its strength will be insufficient.

Side effects and complications of meningococcal vaccination

Studies of the pharmacological action of the vaccine have identified several frequent post-vaccination reactions. The first of them, which occurred in a quarter of patients, was redness and slight swelling at the injection site. Such changes occurred on the first day after immunoprophylaxis and disappeared without a trace over the next few days.

Another reaction is a general increase in body temperature to subfebrile values ​​(up to 37.5⁰ C). The temperature reaction occurred in no more than 5% of those vaccinated.

Doctor's advice. An increase in temperature to subfebrile numbers is not a cause for concern and the use of antipyretics. This reaction is physiological and does not require medical correction.

The medical community still has no consensus on immunization through vaccination. It is divided into two camps: opponents of vaccination and supporters. One of the main arguments of the first group is the information that vaccination causes autism in children. Such consequences are associated with the action of merthiolate, a mercury compound that is included in most vaccinations as a preservative. This fact has been verified by many clinical studies. They showed that there is no relationship between childhood autism and vaccination.

There is also an opinion that vaccination is just part of the pharmaceutical business and a way for vaccine companies to make money. Proponents of the vaccination method give many arguments that have been tested in practice. And the most important of them is the protection of a person from diseases, the treatment of which is difficult and which often lead to serious complications.

Vaccine storage conditions

The vaccine is stored according to the storage standard for immunobiological preparations. It provides for a special temperature regime. For this purpose, refrigeration units are used to store vaccines. Transportation of the meningococcal vaccine is possible at temperatures up to 25⁰ C for no longer than one week. It is unacceptable to get direct sunlight and ultraviolet rays on the drug. This changes its pharmacological properties.

Vaccine analogues

Meningococcal vaccine analogues contain several polysaccharides of the meningococcal capsule. These include:

• Menactra - contains A, C, Y, W-135 serogroup of meningococcus polysaccharides. They are conjugated on a special carrier protein.
• Mencevax ACYW is a domestic drug similar to Menactra in composition.
• Menugate is a French vaccine that contains the C-serogroup of the meningococcus polysaccharide.

When choosing a drug for vaccination against meningococcal infection, preference is given to multicomponent vaccines.

Meningococcal disease is an acute anthroponotic (only people get sick) infectious disease of the respiratory tract caused by meningococcus. The main clinical manifestations of the infection are nasopharyngitis, purulent meningitis and sepsis. The focus of infection is infected people and bacteria carriers. In epidemiological terms, people with nasopharyngitis are the most dangerous. The infection is transmitted by airborne droplets, coughing, sneezing, and a runny nose contribute to its spread.

Neisseria meningitidis - the causative agent of meningococcal infection (photo: www.en.ppt-online.org)

Children under the age of 10 are more susceptible to the disease. Both isolated cases of infection and epidemic outbreaks can be observed. Group A meningococcus can cause epidemics. After an infection, a persistent type-specific immunity is formed. The polysaccharide meningococcal A+C vaccine is used to prevent infection.

Polysaccharide meningococcal vaccine A + C: composition and form of release

Polysaccharide meningococcal vaccine A + C is made in the form of a lyophilisate (powder) for intramuscular and subcutaneous administration. One dose of the drug (half a milliliter) contains the following components:

• Purified lyophilized polysaccharides of Neisseria meningitidis serogroups A and C, 50 mcg.
• Lactose as a lyophilisate.

The composition of the solvent includes, mg:

• Sodium chloride - 4.15.
• Dibasic sodium phosphate - 0.065.
• Monobasic sodium phosphate - 0.023.
• Water for injection - up to 0.5 ml.

The vaccine is dissolved immediately before administration. As a solvent, only the one that comes with the lyophilisate is used.

Characteristics of the vaccine (pharmacological action)

The action of the drug is aimed at the formation of type-specific immunity against meningococcal infection. The vaccine contains bacterial particles (antigens). They, getting into the body, stimulate a local reaction. Lymphocytes and other cells of the immune system begin to migrate to the focus of inflammation. The antigens are recognized and the body begins the process of producing specific antibodies (against A and C types of infection). Immunity is maintained for 3 years after vaccination. Vaccination does not prevent the occurrence of meningitis of a different etiology (group B meningococcus, Haemophilus influenzae, streptococcus).

Indications for the introduction of the vaccine

Vaccination is intended to prevent meningococcal infection type A and C. This is relevant in cases of epidemic or when moving to endemic areas.

Preparation before vaccination includes a doctor's examination and thermometry. Other activities are not required.

Route of administration of the vaccine and dose

The vaccine is administered once. The injection is carried out subcutaneously or intramuscularly for children from 18 months and adults. Before administration, the lyophilisate and injection solution are mixed in the vial. The diluted vaccine is used and must not be stored. After manipulation, the syringe and ampoules are disposed of.

Contraindications for the introduction of the vaccine

Contraindications for the introduction of the vaccine are divided into 2 groups: absolute and relative. Absolute contraindications are established in case of a high risk of developing life-threatening conditions. These include:

• Severe reaction to the previous injection of the drug (fever up to 39 degrees Celsius, swelling or redness of the skin at the injection site with a diameter of more than 8 cm).
• Complications with the introduction of a previous dose of the same vaccination (anaphylactic shock, collapse (a sharp drop in blood pressure), encephalitis, convulsions).
• Immunodeficiency states (primary and acquired).

Relative contraindications are temporary conditions in which vaccination may not provide the necessary immune response. The most common relative contraindication is ARI, which occurs with a high temperature. In such cases, vaccination is postponed until the condition returns to normal.

Important! The presence of a mild illness in a child (a runny nose without fever) is not a contraindication to routine vaccination. In the presence of chronic diseases, the decision on the advisability of immunization is made by the attending physician

There is also a group of erroneous contraindications. These include:

• Dysbacteriosis.
• Thymomegaly (enlargement of the thymus).
• Anemia.
• Atopic dermatitis and diathesis.
• Some congenital diseases (Down's disease).

Before vaccination, the presence of a contraindication should be assessed. If they are present, it is better not to immunize. In this case, vaccination will not only not bring the expected effect, but also increase the risk of adverse reactions.

Side effects of the vaccine

The vaccine causes a minimum of adverse reactions. Most often, local reactions occur in the form of soreness, redness and induration at the injection site. They are short-term, disappear within 2-3 days and do not require additional treatment. There is also an increase in temperature, which is quickly stopped by antipyretics.

In case of individual intolerance to the drug, anaphylactic reactions may occur. They are characterized by the following clinical picture:

• Difficulty breathing.
• Low blood pressure.
• Damage to the skin and mucous membranes - the appearance of a rash and swelling.
• Loss of consciousness.
• Paleness of the skin.

Doctor's advice. Stay in the hospital for half an hour after the vaccination. As a rule, allergic reactions to the introduction of the vaccine occur during this period of time. If the body reacts incorrectly, they will be able to provide you with the necessary medical assistance.

Epinephrine (adrenaline) is used to treat anaphylactic shock. This drug is the initial therapy for anaphylaxis with no contraindications. Epinephrine solution is recommended to be injected intramuscularly into the middle anterolateral part of the thigh. In case of insufficient clinical effect, the injection is repeated every 5-15 minutes. Minor side effects - increased heart rate, tremor, anxiety, headache.

The following groups of drugs are used as adjuvants:

• Antihistamines (Loratadine).
• Glucocorticosteroids (Prednisolone).
• Bronchodilators (Salbutamol).

It is much easier to prevent adverse reactions than to deal with their consequences. Therefore, before vaccination, it is important to undergo a medical examination. He will evaluate the indications and contraindications, determine the need for vaccination.

Vaccine use

The meningococcal vaccine is optional and is not part of the National Immunization Schedule. The dosage of the vaccination is 0.5 ml. For children, the vaccine is injected into the front outer part of the thigh, for adults - into the deltoid muscle. The vaccine is given deep subcutaneously or intramuscularly. Studies on the effect of vaccination on pregnant women have not been conducted. Therefore, the vaccine is used only when there is a high risk of infection.

Meningococcal infection is a dangerous disease that is fraught with complications. The disease affects the nervous and other systems and organs. With a fulminant course, the child may die after a few days, since the treatment will not bring the desired effect. Therefore, today vaccination is an effective way to develop immune protection against infection. Do not be afraid of adverse reactions and unwanted effects, because they rarely occur. Negative consequences are associated with violation of the rules of asepsis and antisepsis, ignoring contraindications and non-compliance with the doctor's advice. Vaccination should be taken seriously. Only in this way can an effective immune response be achieved.

special instructions

One of the features of the A+C meningococcal polysaccharide vaccine is that the lyophilisate and diluent must be diluted just prior to administration. No special preparation is required before vaccination.

After immunization, the person being vaccinated is advised to refrain from:

• Visits to swimming pools, baths, saunas.
• Active sports.
• The use of alcoholic beverages.
• Overheating and hypothermia.

Young children during the vaccination period should not be given allergenic foods (citrus fruits, chocolate, nuts). In the event that an undesirable reaction occurs, it will be difficult to determine what origin it is.

Interaction with other immunoprophylaxis agents

The interaction of the polysaccharide meningococcal vaccine A + C with other drugs has not been described. Therefore, the simultaneous administration of vaccination and immunomodulating agents is not recommended.

Vaccine storage conditions

The vaccine is stored in the refrigerating devices of vaccination rooms at a temperature of plus 2 to 8 degrees Celsius. The vaccine is not frozen. Transport the drug, adhering to the rule of the cold chain. Direct sunlight on the vaccine is unacceptable (it will lose its immunomodulatory properties). Expiration date - 36 months. After its expiration, the drug is disposed of.

Vaccine analogues

There are several drugs that are similar in mechanism of action to the polysaccharide meningococcal A+C vaccine. These include:

• Meningococcal vaccine (Russia).
• Mengok V and S (Russia).
• Mencevax ACWY (Belgium).
• Menactra (USA).

Vaccinations differ by country of origin and pricing policy. The quality of the immune response does not change from this.

Contents

FS.3.3.1.0015.15 Meningococcal serogroup A vaccine, dry polysaccharide

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

PHARMACOPIES AUTHORIZATION

meningococcal vaccineFS.3.3.1.0015.15

serogroup A polysaccharide

dry Instead of FS 42-3720-99

This monograph applies to meningococcal serogroup A dry polysaccharide vaccine, which is a lyophilizate of purified capsular polysaccharide Neisseria meningitidis serogroup A.

Polysaccharide Neisseria meningitidis serogroup A consists of partially O-acetylated repeating fragments of N-acetylmannosamine linked by 1α-6 phosphodiester bonds.

PRODUCTION

The technology for obtaining a meningococcal polysaccharide serogroup A vaccine involves cultivating the producer strain in a liquid Franz nutrient medium, followed by isolation of the serogroup A meningococcal polysaccharide from the obtained biomass and its purification.

Production Strain Cultivation Process N. meningitidis should be carried out on dense nutrient media that do not contain blood elements and other substrates of animal origin. The entire manufacturing process, based on the use of an inoculum system, and ensuring the stable production of a vaccine for the prevention of serogroup A meningococcal disease with the required immunogenicity and safety in humans, must be validated.

seed. Producer strain N. meningitidis must be characterized by its source of isolation and ability to produce serogroup A polysaccharide. Production strain N. meningitidis serogroup A must have the following properties:

• - on nutrient agar with the addition of 20% bovine serum, it should form round, smooth, transparent, colorless shiny colonies with even edges, slightly convex, soft in consistency, which are easily removed from the surface of the medium. Colonies should be 0.5 to 2 mm in diameter. In oblique light, the colonies should have a bright orange color with an iridescent glow;
• - Gram-stained smears should contain gram-negative diplococci, arranged in pairs in the form of "coffee beans", as well as tetrads or clusters;
• — the culture of the test strain must be oxidase-positive;
• - the culture of the test strain should decompose glucose and maltose with the formation of acetic acid and should not decompose lactose, sucrose and fructose;
• — the culture suspension of the test strain should enter into an agglutination reaction only with a specific serum of serogroup A and not agglutinate with sera against other meningococcal serogroups, and also not give a spontaneous agglutination reaction in 0.9% sodium chloride solution.

The bacteriological purity of the producer strain must be confirmed by inoculation on sensitive nutrient media, the study of the morphology of the colonies, microscopy of Gram-stained smears, as well as the formulation of the agglutination reaction with specific and non-specific sera.

At the stage of cultivation of the production strain, in order to obtain the final volume of biomass, a liquid semi-synthetic medium is used that does not contain substances that can be precipitated by cetyltrimethylammonium bromide, and also does not contain blood elements or high molecular weight polysaccharides.

The bacteriological purity of the obtained biomass must be evaluated and confirmed by the methods used to assess the purity of the producer strain. The bacterial collection is centrifuged and the polysaccharide is precipitated from the supernatant by adding cetyltrimethylammonium bromide to its final concentration of 0.01%, followed by extraction of the polysaccharide from the cetavlon-polysaccharide complex with a solution of calcium chloride. The resulting polysaccharide is stored at a temperature of minus 20 °C.

The substance of the polysaccharide serogroup A meningococcal vaccine is a polysaccharide purified from nucleic acids, protein and lipopolysaccharide by stepwise fractionation with ethanol and extraction with phenol. The purified substance is dried in a desiccator to constant weight over calcined calcium chloride and stored at a temperature of minus 20 °C.

At the production stage, the substance is tested according to the following indicators:

Authenticity

The substance must inhibit the reaction of passive hemagglutination (positive HTPHA) in the homologous "A" system at a concentration not exceeding 0.4 μg of polysaccharide in 1 ml, in the absence of an inhibitory effect in the heterologous "C" system with a polysaccharide content of 50 μg / ml (see. subsection "Authenticity" of the section "Tests").

Protein

Not more than 1%. The determination is carried out according to the Lowry method without preliminary protein precipitation in accordance with. The substance is pre-dissolved in purified water to a concentration of 5 mg/ml.

Nucleic acids

Not more than 1%. The determination is carried out in accordance with. The substance is pre-dissolved in purified water to a concentration of 5.0 mg/ml.

O-acetyl groups

Not less than 2 µmol/mg. Tests are carried out in accordance with the General Pharmacopoeia Monograph "Determination of O-acetyl groups". The substance is preliminarily dissolved in purified water to a concentration of 1 mg/ml.

Phosphorus

Not less than 8%. The determination is carried out in accordance with.

Molecular parameters

At least 65% of the polysaccharide eluted to achieve a partition coefficient Kd of 0.50 (subsection "Molecular parameters" of the "Tests" section).

Pyrogenicity

The substance must be pyrogen-free. Tests are carried out in accordance with. A test dose of 0.025 μg/ml is administered at 1 ml per 1 kg of animal weight.

TESTS

Description

Amorphous mass in the form of a tablet or loose powder from white to whitish-gray. The reconstituted drug is a colorless or yellowish solution. The determination is carried out visually.

Authenticity

The vaccine should cause inhibition of the passive hemagglutination reaction (positive GHG) in the homologous "A" system, not exceeding 0.4 μg of polysaccharide in 1 ml, in the absence of an inhibitory effect in the heterologous "C" system with a polysaccharide content of 50 μg in 1 ml.

Ingredients for the reaction of inhibition of passive hemagglutination (RPHA):

• - study vaccine solution containing 50 μg of serogroup A polysaccharide in 1 ml;
• - meningococcal sera of serogroups A and C, and diagnosticums of meningococcal erythrocyte serogroups A and C;
• - 0.9% sodium chloride solution.

Determination of the working dilution of meningococcal diagnostic sera. To prepare a working dilution of meningococcal diagnostic sera, their specific titer in RTPHA with diagnosticums of erythrocyte meningococcal serogroups A and C is determined. In 2 rows of wells, starting from the second, add 50 µl of 0.9% sodium chloride solution. In the first wells, 100 μl of meningococcal sera of serogroups A and C, diluted 1:10 with 0.9% sodium chloride solution, are added. Next, two-fold serial dilutions of each serum are prepared, transferring 50 μl of serum from well to well. From the last well, 50 µl of the serum dilution is removed. Then, 25 μl of an erythrocyte diagnosticum, homologous to serum, is added to each well. In 4 wells (control of the absence of spontaneous agglutination of the diagnosticum) add 50 μl of 0.9% sodium chloride solution. 25 µl of serogroup A diagnosticum are added to 2 wells, and 25 µl of serogroup C diagnosticum are added to 2 wells. record the results. The last serum dilution in which agglutination of almost all erythrocytes is observed with an inconspicuous ring of settled non-agglutinated erythrocytes is the serum titer and contains 1 haemagglutinating unit (HAU). The previous dilution contains 2 HAU and is used as the working serum dilution.

In the control wells, agglutination should be completely absent, and erythrocytes should fall to the bottom of the well in the form of hemispheres.

Carrying out RTPGA. In the first wells of 2 rows of the tablet for immunological reactions, 50 μl of the test solution of the meningococcal serogroup A vaccine is added at an initial concentration of 50 μg per 1 ml. 25 μl of 0.9% sodium chloride solution are added to the remaining wells. Then, the initial solutions of the vaccine are titrated by two-fold dilutions in a volume of 25 μl up to and including the 12th well; from the last well, 25 µl is removed. To each well of the first row add 25 µl of working dilution of homologous serum. 25 μl of heterologous serum is added to each well of the second row. After 15 - 20 min exposure at a temperature of 18 to 22 ° C, 25 μl of erythrocyte diagnosticum, homologous to the added serum, is added to each well. Thus, in the 1st row, the reacting mixture will consist of serum and erythrocytes homologous to the vaccine, in the 2nd row it will consist of the vaccine and serum and erythrocytes heterologous to it. The reaction is taken into account after 1.5 - 2 hours of incubation in a thermostat at a temperature of 36 to 38 °C. After the end of the incubation, the minimum concentration of the vaccine is noted, which inhibits erythrocyte agglutination. The specificity of the vaccine is confirmed if the hemagglutination delay is observed only in the homologous system.

The control is the absence of spontaneous agglutination and checking the correctness of the selected working serum dilution.

Dissolution time

The contents of the ampoule should be completely dissolved in 2.5 ml of 0.9% sodium chloride solution within 1 minute with shaking.

Clarity of the reconstituted solution

The reconstituted vaccine must withstand comparison with reference I. The determination is carried out in accordance with. The contents of 4 ampoules are dissolved in 10 ml of 0.9% sodium chloride solution.

Color of the reconstituted solution

The reconstituted vaccine must be comparable to the Y 4 reference. The determination is carried out in accordance with. The contents of 4 ampoules are dissolved in 10 ml of 0.9% sodium chloride solution.

Mechanical inclusions

The reconstituted vaccine must meet the requirements.

Loss on drying

Not more than 2.5%. The determination is carried out in accordance with.

Filling accuracy

Not more than 10%. The determination is carried out by the weight method. 20 ampoules without labels are treated with a mixture of alcohol and ether and placed in a desiccator for 3 hours. Then the top of each ampule is filed and removed. Opened ampoules with the substance are weighed on an analytical balance, after which the contents are removed, the ampoules are washed with water, rinsed with purified water. After that, the ampoules are kept in an oven at a temperature of 100 - 105 ° C until constant weight. The coefficient of variation is calculated from the difference in masses of the ampoule with and without contents V) as a percentage according to the formulas:

S- standard deviation;

is the arithmetic mean value of the mass of the substance in the ampoule;

X is the mass of the substance in each ampoule;

n- the number of ampoules.

Phosphorus

Molecular parameters

Not less than 65% of the polysaccharide eluted before reaching the value of the distribution coefficient Kd = 0.50. The determination of molecular parameters is carried out by size exclusion chromatography in accordance with the procedure set forth in the regulatory documentation, which should indicate: the size of the chromatographic column, the characteristics of the carrier and the method of its preparation, the method for preparing the elution solution, the amount and method of introducing the test and standard samples, the elution rate of the mobile phases, column calibration conditions, volume of eluted fractions, fraction collection procedure.

Polysaccharide content

The vaccine must contain at least 70% and not more than 130% of the polysaccharide that is part of the preparation. The content of the polysaccharide is calculated by converting the content of phosphorus to the polysaccharide or by the immunochemical method described in the regulatory documentation.

Sterility. The vaccine must be sterile. The determination is carried out by direct seeding in accordance with.

Abnormal toxicity

The vaccine must be non-toxic. The determination is carried out in accordance with. Test dose for 5 white mice - 100 μg of polysaccharide intraperitoneally, test dose for 2 guinea pigs - 500 μg of polysaccharide intraperitoneally. The observation period for animals is 7 days.

Pyrogenicity

The vaccine must be pyrogen-free. The determination is carried out in accordance with. A test dose of 0.025 μg/ml of the polysaccharide is administered at a rate of 1 ml per 1 kg of animal weight.

Lactose content. Should be within (10 ± 1) mg per ampoule. The determination is carried out in accordance with. In 3 ampoules with the vaccine add 1 ml of purified water. The contents of the ampoules are combined. Apply 1 drop of the test sample solution to the prism of the refractometer and determine the refractive index. According to the calibration graph, the concentration of lactose is found. The lactose content in 1 ampoule is calculated as the arithmetic mean of 3 measurements.

Construction of a calibration graph. In 10 glass test tubes make a pipette of 0.1; 0.2; 0.3; 0.4; 0.5; 0.6; 0.7; 0.8; 0.9 and 1 ml of the stock solution of lactose, bring the volume with purified water to 1 ml and mix (lactose content, respectively: 2.5; 5; 7.5; 10; 12.5; 15; 17.5; 20; 22, 5 and 25 mg/ml). The refractive index of each solution is measured and a calibration graph is plotted, plotting the amount of lactose in mg/ml along the abscissa and the refractive index along the ordinate. The calibration graph is reproduced with each analysis.

Note.

Preparation of 2.5% lactose stock solution. In a volumetric flask with a capacity of 100 ml, 2.5 g of lactose monohydrate are dissolved in purified water by heating in a water bath at a temperature not exceeding 60 ° C. The volume of the solution was made up to the mark with water and mixed. Cool to room temperature before use. The stock solution is used freshly prepared.

Packaging and labeling

Transportation and storage

At temperatures from 2 to 8 ° C in accordance with.

Meningococci are pathogenic microorganisms that cause a number of dangerous diseases, including purulent and serous meningitis, meningococcemia, and meningococcal sepsis.

They cause serious complications and pose a direct threat to human life, especially when it comes to children and people with weakened immune systems. The bacterium is transmitted by airborne droplets, and one of the few ways to protect yourself from infection is vaccination with special preparations that contribute to the development of immunity and facilitate the clinical course of the disease. Who needs the meningococcal vaccine and when is it given?

When should adults and children be vaccinated against meningococcal disease?

In meningococcal infection, pathogenic microorganisms affect the membranes of the brain or spinal cord, and the disease has a wide range of manifestations.

Sometimes it is asymptomatic (bacteriocarrier), and in some cases it is characterized by a fulminant course, which most often ends in death.

The disease affects people of any age, and the carrier of the infection is always a person - the bacterium is transmitted through close contact or permanent residence next to its carrier.

Vaccination against meningococcus is not included in the list of mandatory, but it is recommended, since even in developed countries epidemics are observed from time to time.

Special protection is required for people who suffer from the following diseases and pathological conditions:

• congenital absence of the spleen or a history of surgery to remove it;
• leakage of cerebrospinal fluid from the nasal or auditory canals;
• some disorders of hematopoiesis (deficiency of factor B, properdin, complement components);
• the presence of cochlear implants - complex devices designed for people with hearing impairments;
• immunodeficiency states;
• congenital anomalies in the structure of the skull.

The risk group includes children under 5 years old, pupils and students living in dormitories, military personnel, as well as employees of institutions that work with dangerous biological preparations. In addition, who have been in contact with persons infected with meningococcal infection, regardless of the presence or absence of signs of the disease.

There are areas in the world with an increased risk of contracting meningococcal infection. This is the so-called African meningitis belt (a zone south of the Sahara), some parts of Asia, Canada, France and the USA. Going to these regions, you must definitely get vaccinated, since the risk of getting sick in this case is extremely high.

Varieties

Vaccines used to prevent meningitis are divided into several categories depending on the principle of action and the number of components aimed at combating different bacterial serotypes. In total, there are 13 serogroups (types) of meningococcus, but most often the disease is caused by types A, B, C, W, Y.

Polysaccharides

The most common drugs for the prevention of meningococcal infection.

They develop a good immune response against the causative agent of the disease, and when meningococcus enters the body, the disease proceeds much easier and does not cause serious complications.

The only strain of bacteria against which it is not possible to develop a polysaccharide vaccine is serotype B.

To protect against microorganisms of this variety, special preparations are used that are made on the basis of the meningococcal membrane protein and are designed to combat specific strains of meningococci.

Polyvalent

Polyvalent vaccines, unlike monovalent ones, contain several varieties of meningococci. The most common prophylactic agents against meningococcal disease are bivalent (pathogen groups A and C), trivalent (A, C and W) and tetravalent (A, C, Y and W135).

The epidemiological situation with meningococcal infection is considered normal in cases where the incidence does not exceed 2 cases per 100,000 population. If the rates rise, doctors talk about an epidemic of the disease, and the vaccine is included in the national vaccination schedule.

Name of imported and domestic meningococcal vaccines

Vaccines against meningococcus are produced both abroad and in domestic laboratories, and each of them has its own characteristics, advantages and disadvantages, and the choice of the drug depends on the region, the epidemiological situation and the characteristics of the human body.

Meningo A+C

Meningo A + C is a bivalent polysaccharide vaccine that is used to prevent meningococcal infections of serotypes A and C. It is available as a powder for the preparation of solutions, rarely causes adverse reactions and provides strong immunity, but is ineffective against diseases caused by meningococci B.

- the name of one of the few vaccines that are used to combat the most dangerous group B bacteria for humans.

This is a newly developed drug, licensed only in 2012, but already well established in countries with a high epidemiological risk.

Menactra

A prophylactic agent that induces a long-lasting and sustained immune response against four meningococcal serotypes - A, C, Y and W-135. The vaccine is approved for use at the age of 2 to 55 years, is well tolerated by the body and has a minimum number of contraindications. The country of origin is the USA.

Mencevax ACWY

A vaccine called produced in Belgium and protects the body against pathogens that belong to groups A, C, Y and W-135. The drug is highly effective, has a minimum number of contraindications and can be used even in childhood.

Meningitec

Meningitec is used to prevent meningococcal infection caused by type C bacteria. It is often recommended for vaccination of children and adults, as the solution contains a minimal amount of aluminum hydroxide, a component that often causes adverse reactions in the body.

All vaccines against meningococcal infection can cause side effects, so it is better to vaccinate in a clinic where a person can immediately receive medical care.

Instructions for use

Features of the use of vaccines against meningococcal infection depend on the specific drug, but there are general rules that must be observed when immunizing children and adults.

Vaccination scheme

The meningococcal vaccine is administered once, the recommended age is from 18 months to 55 years.

Young children are vaccinated only if they come into contact with carriers of the disease, but the immune response will be low enough that subsequent injections will be required.

Babies who were vaccinated before the age of 2 years are re-immunized after three months, and the next dose is administered after three years.

When traveling to areas with an unfavorable epidemiological situation, children over two years old and adults are vaccinated immediately before traveling, and six-month-old babies need to undergo the procedure at least two weeks in advance so that immunity can develop in the body.

Dosage regimen

On average, babies aged from one year to 8 years are administered 0.25-0.5 ml of the drug, and older children and adults 0.5 ml each, but dosages may differ depending on the instructions for use of a particular vaccine. The solution is injected subcutaneously into the upper part of the shoulder or under the shoulder blade.

When introducing vaccines, it is imperative to follow the rules for administration and sanitary standards, otherwise there will be no effect from immunization, and in some cases, unpleasant consequences are possible.

How long does the vaccine last?

The effectiveness of vaccination against meningococcal infection is 85-95%. In children, immunity persists for 3 years, after which re-vaccination is recommended, and in adults, antibodies to pathogenic microorganisms remain in the body for up to 10 years.

Contraindications

Absolute contraindications to the introduction of prophylactic drugs are hypersensitivity to vaccine components and severe allergic reactions to the introduction of polysaccharide vaccines in the past. Relative contraindications include acute infectious diseases, which are accompanied by fever and other symptoms. In the presence of a high risk of infection, drugs are administered even to pregnant and lactating women under strict medical supervision.

How is vaccination tolerated: side effects and complications

Prophylactic drugs for meningococcal disease are generally well tolerated by the body, but in some cases the following side effects are possible:

• seals, infiltrates and soreness at the injection site of the solution;
• fever, headache, drowsiness;
• allergic reactions up to anaphylactic shock.

If adverse reactions are not too pronounced, they do not require medical intervention and pass on their own, but if the condition of a person seriously deteriorates, they should be immediately taken to the hospital.

Is there a vaccine for meningococcemia?

Meningococcemia is one of the manifestations of meningococcal infection, which most often develops in childhood. Accordingly, vaccines designed to protect the body against meningococci are used to prevent the disease.

How much does the meningococcal vaccine cost - average prices

Since meningococcal vaccination is not included in the list of mandatory, the vaccine must be purchased independently, or vaccinated in private medical institutions. The approximate cost of one dose of the drug is 2 thousand rubles, but the price may vary in different regions and pharmacies.