Vaccine meningococcal group A polysaccharide (Vaccinum meningococcium gruppae A polysaccharidicum). Vaccination against meningococcal disease in children and adults Meningococcal vaccine storage temperature

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 lyophilisate of purified capsular polysaccharide Neisseria meningitidis serogroup A.

Polysaccharide Neisseria meningitidis serogroup A consists of partially O-acetylated N-acetylmannosamine repeating fragments 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 prior 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 reaction of passive hemagglutination (positive HTPHA) 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 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.

Federal State Unitary Enterprise NPO Microgen, Russia

• Release form:
  1 ampoule / 5 doses for children 9 years and older
  and 10 doses for children from 1 to 8 years old inclusive No. 5 + solvent.
• Vaccination schedule: once. Vaccination dose for children from 1 year to 8 years inclusive - 0.25 ml; aged 9 years and older - 0.5 ml. Revaccination after 3 years.

Instructions for use

Registration certificate holder:

NPO MICROGEN, FSUE (Russia)

ATX code: J07AH01 (Meningococcus A, purified polysaccharides antigen)

Active ingredient: meningitis polysaccharide vaccine (meningococcal polysaccharide vaccine)

Ph.Eur. European Pharmacopoeia

Dosage form

reg. No.: ЛС-000302 dated 04/27/10 - Valid

Release form, composition and packaging

Solvent: 0.9% solution of sodium chloride - 5 ml.

1 amp. (5 doses) - ampoules (5) complete with a solvent (5 amp. 5 ml each) - cardboard packs.

Clinico-pharmacological group: Vaccine for the prevention of diseases caused by meningococci

Pharmacotherapeutic group: MIBP vaccine

The scientific information provided is general and cannot be used to make a decision on the possibility of using a particular medicinal product.

pharmachologic effect

Causes an increase in specific antibodies to Neisseria meningitidis serogroups A, C, W135 and Y.

Indications

Prevention of meningococcal infection caused by meningococci of groups A and C in children and adults.

Dosing regimen

Single vaccination from 18 months of age in 1 dose, regardless of age. The vaccine is administered s / c or / m.

Side effect

Very rarely:(more likely in adults) in the first 72 hours after administration - slight fever, chills, weakness; slight and short-term reddening of the skin and soreness at the injection site.

Contraindications for use

Acute and chronic diseases.

Use during pregnancy and lactation

Pregnancy and lactation are not a contraindication in adverse epidemic situations.

Use in children

special instructions

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.

Rotavirus infection: what is important to know?

There are several types of the virus, but serotypes A, B, C are pathogenic for humans, and type A is the most common. This virus affects not only humans, but also various species of mammals and birds. Group A rotavirus is considered one of the most common causes of infectious diarrhea in children.

Poliomyelitis is an acute infectious human disease, which is accompanied by damage to the nervous system, the development of paresis and paralysis. Poliomyelitis mainly affects children under 5 years of age. 1 in 200 infections results in permanent paralysis. Among those paralyzed, 5% to 10% die when their breathing muscles become immobile.

Many parents panic, confusing rotavirus, dysentery and poisoning. Doctors warn that one of the main differences is chair character.

In recent years, there has been an ambiguous attitude towards vaccinations in the world. Despite the fact that universal vaccination against certain diseases has led to their almost complete disappearance, the ranks of opponents of mandatory vaccinations are growing. This is facilitated by the widespread misconceptions regarding vaccination.

In the body of a healthy person, there are a trillion useful (85%) and one hundred and fifty billion pathogenic (15%) microorganisms. Throughout life, they compete with each other. If the balance shifts towards pathogenic bacteria, the microflora is destroyed, dysbacteriosis occurs, the person's well-being worsens, and the question arises "how to restore health."

Vaccine meningococcal group A polysaccharide

Compound

Vaccine Meningococcae

Therapeutic indications

Provided in section Therapeutic indications Vaccine meningococcal group A polysaccharide Therapeutic indications in the instructions for the medicine Vaccine meningococcal group A polysaccharide

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Prevention of invasive meningococcal infection caused by N. meningitidis serogroups A, C, Y and W-135 in individuals aged 9 months to 55 years.

Prevention of cerebrospinal meningitis of meningococcal etiology of serogroups A and C (in endemic areas or in case of an epidemic).

Dosage and administration

Provided in section Dosage and administration Vaccine meningococcal group A polysaccharide information is based on data from another drug with exactly the same composition as the drug Vaccine meningococcal group A polysaccharide(Vaccine Meningococcae). Be careful and be sure to clarify the information in the section Dosage and administration in the instructions for the medicine Vaccine meningococcal group A polysaccharide directly from the package or from the pharmacist in the pharmacy.

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PC, once.

One immunizing dose is 0.5 ml of the dissolved vaccine.

The vaccine is dissolved before use with the attached solvent at the rate of 0.5 ml per 1 dose. Shake the vial thoroughly until the contents are completely dissolved within 1 min. The dissolved drug is a clear, colorless solution. If it looks different, and also in the presence of foreign particles, the vaccine is not used.

After diluting the lyophilisate with a solvent, the vaccine should be used immediately. It is allowed to store the solution in a vial containing 10 doses in the refrigerator for no more than 8 hours. The solution should be protected from direct sunlight.

A new sterile needle must be used to administer the drug. When using a vaccine in a multi-dose package, a new syringe and needle should be used each time the drug is withdrawn. The dissolved drug in a multi-dose package should be used during the working day. The drug must be removed from the vial with strict observance of the rules of asepsis.

Under no circumstances should Mencevax ACWY be administered intravenously.

Contraindications

Provided in section Contraindications Vaccine meningococcal group A polysaccharide information is based on data from another drug with exactly the same composition as the drug Vaccine meningococcal group A polysaccharide(Vaccine Meningococcae). Be careful and be sure to clarify the information in the section Contraindications in the instructions for the medicine Vaccine meningococcal group A polysaccharide directly from the package or from the pharmacist in the pharmacy.

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Solution for intramuscular injection

Lyophilisate for the preparation of a suspension for intramuscular and subcutaneous administration

known hypersensitivity with systemic manifestations to any component of the vaccine, including diphtheria toxoid, or to previous administration of other vaccines containing the same components;

acute infectious and non-infectious diseases, exacerbation of chronic diseases (in these cases, vaccination is carried out after recovery or in remission).

Hypersensitivity, acute infectious diseases, progressive diseases (acute or chronic). Children's age (up to 18 months) during the non-epidemic period.

Side effects

Provided in section Side effects Vaccine meningococcal group A polysaccharide information is based on data from another drug with exactly the same composition as the drug Vaccine meningococcal group A polysaccharide(Vaccine Meningococcae). Be careful and be sure to clarify the information in the section Side effects in the instructions for the medicine Vaccine meningococcal group A polysaccharide directly from the package or from the pharmacist in the pharmacy.

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Solution for intramuscular injection

Lyophilisate for the preparation of a suspension for intramuscular and subcutaneous administration

The nature and frequency of side effects identified in the studies varied depending on the age of the vaccinated.

In clinical studies in children aged 9 to 18 months, within 7 days after vaccination, sensitivity at the injection site and soreness were most often noted. During clinical studies in children from 2 to 10 years of age, pain and redness at the injection site, irritability, diarrhea, drowsiness, anorexia were most often noted; in adolescents from 11 to 18 years of age and in adults from 18 to 55 years of age, pain at the injection site, headache and fatigue were most often noted.

The incidence of the following side effects is classified according to WHO recommendations and includes the following categories: very often - 10%; often - ≥1 and<10%; нечасто — ≥0,1 и <1%; редко — ≥0,01 и <0,1%; очень редко — <0,01%; частота неизвестна — не может быть определена согласно имеющимся данным.

Children aged 9 to 18 months

Most of the reported local and general reactions observed within 7 days after vaccination were mild and lasted less than 3 days.

In addition, the following side effects have been noted:

very often - loss of appetite;

From the nervous system: very often - drowsiness.

From the gastrointestinal tract: very often or often - vomiting.

very often - soreness, erythema at the injection site, swelling at the injection site, irritability, abnormal crying, fever.

Children from 2 to 10 years old

Most of the reported local and general reactions observed within 7 days after vaccination were mild. In addition, the following violations were noted:

From the side of metabolism and nutrition:

From the nervous system: very often or often - drowsiness.

From the gastrointestinal tract: very often - diarrhea; often - vomiting.

often - rash, urticaria.

often - arthralgia.

General disorders and disorders at the injection site: very often - soreness and induration at the injection site; very often or often - irritability, redness at the injection site, swelling at the injection site, fever.

Patients aged 11-55

Most of the reported local and general reactions observed within 7 days after vaccination were mild. In addition, the following violations were noted.

From the side of metabolism and nutrition: very often or often - loss of appetite.

From the nervous system: very often - headache.

From the gastrointestinal tract: very often or often - diarrhea; often - vomiting.

From the skin and subcutaneous tissues: often a rash.

From the side of the musculoskeletal and connective tissue: very often - arthralgia.

General disorders and disorders at the injection site: very often - pain, induration, redness and swelling at the injection site, fatigue, general malaise; often - chills, fever.

In the post-marketing period, information was additionally obtained on the following adverse events after the administration of the drug (at present, the frequency of these events and their causal relationship with the use of the Menactra vaccine cannot be determined).

From the immune system: hypersensitivity reactions such as anaphylactic shock, anaphylactoid reactions, stridor breathing, difficulty in breathing, swelling of the upper respiratory tract, urticaria, redness of the skin, pruritus, lowering blood pressure.

From the nervous system: Guillain-Barré syndrome (GBS), paresthesia, loss of consciousness (due to dysregulation of the autonomic nervous system), dizziness, convulsions, facial paralysis, acute disseminated encephalomyelitis, transverse myelitis.

From the side of the musculoskeletal and connective tissue: myalgia.

Post-marketing research

The risk of GBS after administration of Menactra was assessed in a US retrospective cohort study using an electronic health care database of 9,578,688 patients aged 11-18 years, of whom 1,431,906 (15%) received Menactra. None of the patients described in the 72 reports of medically confirmed cases of GBS received the Menactra vaccine within 42 days prior to the onset of symptoms. An additional 129 potential cases of GBS were not medically confirmed or were excluded from the analysis due to lack of or insufficient medical information. In an analysis that took into account missing data, the estimated additional risk of GBS ranged from 0 to 5 additional cases of GBS per 1,000,000 vaccinated within 6 weeks of vaccination.

During the first 3 days after vaccination, sometimes (more often in children than in adults) there is a slight redness at the injection site, hyperthermia (quickly disappearing after taking antipyretics), irritability, weakness.

Overdose

Provided in section Overdose Vaccine meningococcal group A polysaccharide information is based on data from another drug with exactly the same composition as the drug Vaccine meningococcal group A polysaccharide(Vaccine Meningococcae). Be careful and be sure to clarify the information in the section Overdose in the instructions for the medicine Vaccine meningococcal group A polysaccharide directly from the package or from the pharmacist in the pharmacy.

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No reliable data.

Pharmacodynamics

Provided in section Pharmacodynamics Vaccine meningococcal group A polysaccharide information is based on data from another drug with exactly the same composition as the drug Vaccine meningococcal group A polysaccharide(Vaccine Meningococcae). Be careful and be sure to clarify the information in the section Pharmacodynamics in the instructions for the medicine Vaccine meningococcal group A polysaccharide directly from the package or from the pharmacist in the pharmacy.

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The vaccine induces immunity (maintains for 3 years after vaccination) only against meningitis caused by meningococci of serogroups A and C; does not provide protection against purulent meningitis of a different etiology: group B meningococci, Haemophilus influenzae, Streptococcus pneumoniae, etc.

Menactra vaccine was administered concomitantly with a polysaccharide typhoid vaccine and an adsorbed tetanus and diphtheria toxoid vaccine intended for use in adults (Td), in persons aged 18-55 years and 11-17 years, respectively.

In children under 2 years of age, Menactra vaccine was given with one or more of the following vaccines: pneumococcal conjugate vaccine (PCV), measles, mumps, rubella vaccine, varicella vaccine, or hepatitis A vaccine.

There are no data to evaluate the safety and immunogenicity of Menactra vaccine when co-administered at 18 months of age with DPT-containing vaccines. Titers of pneumococcal antibodies against some serotypes contained in the 7-valent pneumococcal conjugate vaccine (PCV7) have been reduced after the simultaneous administration of Menactra vaccine and PCV7 vaccine.

BCG vaccine should not be used concomitantly with Menactra vaccine.

It is always necessary to administer vaccines to different parts of the body, using separate syringes for each of them.

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?

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 schedule

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

• 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.