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Used for passive immunization against hepatitis B. Preparations for passive immunization

Neutralization of the source of infection is achieved by timely identification of all patients and virus carriers, followed by the organization of their treatment and observation, completely eliminating the possibility of spreading the disease in the environment of patients.

Hepatitis B vaccination schedules

To create lasting immunity, the vaccine must be administered three times. The first two injections can be considered as initial doses, while the third serves to enhance antibody production. The administration schedule can vary significantly, with the second injection usually given 1 month after the first, and the third 3 or 6 months after the second. In some cases, you can resort to an accelerated vaccination regimen, for example, according to the 0-1-2 month or 0-2-4 month scheme. In this case, an earlier formation of a protective level of antibodies is observed in a larger number of patients. When using regimens with a longer interval between the second and third injections (for example, 0-1-6 or 0-1-12 months), seroconversion occurs in the same number of patients, but the antibody titer is higher than with accelerated vaccination regimens. The dose of the vaccine is calculated by age, taking into account the drug used.

In many countries, vaccination against hepatitis B is included in the vaccination schedule and begins immediately after birth and is carried out according to the 0-1-6 month schedule. In some countries, vaccination is carried out only in risk groups (medical workers, primarily surgeons, dentists, obstetricians, blood transfusion workers, patients on hemodialysis or frequently receiving blood products, etc.). Children born to mothers who are carriers of the hepatitis B virus are subject to mandatory vaccination. In these cases, it is recommended immediately after birth (no later than 48 hours) to administer 0.5 ml of immunoglobulin against the hepatitis B virus (not necessary in recent years) and begin three-time immunization with the vaccine according to scheme 0-1-6 months.

The hepatitis B vaccine is administered only intramuscularly; in adults and older children it should be injected into the deltoid muscle area; in young children and newborns, it is preferable to be injected into the anterolateral thigh. Vaccine injections into the gluteal region are undesirable due to a decrease in immune tension.

Currently, according to the domestic calendar, newborns from risk groups are vaccinated according to the scheme 0-1-2-12 months of life.

For children who are not at risk, vaccination against hepatitis B is carried out according to the 0-3-6 scheme (the first dose - at the start of vaccination, the second - 3 months after the first vaccination, the third - 6 months from the start of immunization).

Post-vaccination immunity

According to our clinic, in newborns vaccinated in the first 24 hours of life with the recombinant Engerix B vaccine according to the 0-1-2 month schedule with revaccination at 12 months, seroconversion occurred in 95.6% of cases, while the level of anti-HB after the third dose amounted to 1650+395 IU/l. and before revaccination - 354+142 IU/l. After administration of a booster dose, the level of antibodies increased 10 times or more. 1 month after completion of the Engerix B vaccination course in different groups (newborns, medical workers, students, etc.), a protective antibody titer is detected in 92.3-92.7% of vaccinated individuals. After 1 year, antibody titers decrease, but remain protective in 79.1-90% of vaccinated people.

The vaccination effectiveness index ranged from 7.8 to 18.1, but in patients in hemodialysis departments it was only 2.4.

Based on the generalized experience of using the Engerix B vaccine in 40 countries, WHO concluded that the seroconversion rate after administration of 3 doses according to the 0-1-2 or 0-1-6 month schedule is close to 100%. Administration of the third dose in the 2nd month, compared with the administration of the third dose at the 6th month, ultimately leads to a less significant increase in antibody titers, so the 0-1-6 month immunization schedule can be recommended for routine vaccination, while the 0-1-2 month schedule - in cases where you need to quickly achieve a sufficient degree of immunity. Subsequently, more reliable antibody levels can be achieved in these children by administering a booster dose after 12 months.

It is more difficult to resolve the issue of the duration of post-vaccination immunity. According to most literature sources, the level of peclet antibodies after completed three-time vaccination decreases rapidly during the first 12 months after vaccination, then the decrease in level occurs more slowly. Most authors are inclined to believe that there is most likely no need to revaccinate patients with high seroconversion rates (above 100 IU/d). At the same time, it is suggested that the body’s immunological memory is as reliable a means of protection against HBV infection as regular administration of maintenance doses of the vaccine. The UK Department of Health believes that until the question of the duration of post-vaccination immunity is finally clarified, it should be considered advisable to revaccinate patients with a protection level below 100 IU/l.

Vaccine reactions and complications after hepatitis B vaccination

Recombinant vaccines against hepatitis B are low reactogenic. Only a few patients experience a reaction at the injection site (mild hyperemia, less often swelling) or a general reaction in the form of a short-term increase in body temperature to 37.5-38.5 °C.

In response to the introduction of foreign recombinant vaccines (Engerix B and others), local reactions (pain, hypersensitivity, itching, erythema, ecchymosis, swelling, nodule formation) occur in a total of 16.7% of vaccinated people; among general reactions, asthenia was noted in 4.2%, malaise - in 1.2%, increased body temperature - in 3.2%, nausea - in 1.8%, diarrhea - in 1.1%, headache - in 4.1%; Increased sweating, chills, hypotension, Quincke's edema, decreased appetite, arthralgia, myalgia, etc. are also possible.

Similar adverse reactions are described after the introduction of the domestic vaccine Combiotech. All these reactions do not significantly affect health, are short-lived and, most likely, are caused by the presence of yeast protein impurities in recombinant vaccines.

Precautions and contraindications for hepatitis B vaccination

There are no permanent contraindications to vaccination against hepatitis B. However, in people with hypersensitivity to any component of the vaccine (for example, baker's yeast protein), as well as in the presence of a severe infectious disease, vaccination should be postponed or canceled.

Vaccination against hepatitis B should be carried out with some caution in patients with severe cardiovascular insufficiency, patients with chronic diseases of the kidneys, liver, and central nervous system. However, such conditions do not serve as a contraindication to the administration of recombinant vaccines, and if we consider that these patients are especially often infected with hepatitis B during various parenteral procedures during examination and treatment, it becomes obvious that they should be vaccinated first.

We have to take into account the fact that in patients with immunodeficiency conditions (malignant neoplasms, hematological malignancies, congenital and acquired immunodeficiencies, etc.) and in patients on immunosuppressive therapy, in order to create intense immunity, an increase in the frequency of vaccine administration is required (scheme 0-1-3 -6-12 months).

Vaccination in pregnant women can only be carried out if the potential benefit justifies the possible risk to the fetus.

On combining vaccination against hepatitis B with the administration of other vaccines

The implementation of the Russian program for hepatitis B vaccine prevention, starting from the neonatal period, invariably poses to every pediatrician the question of combining the vaccine with other vaccines, and primarily with the BCG vaccine. From a scientific point of view, concerns about the incompatibility of these vaccines are without any basis, since it is known that an increase in the level of protection with the introduction of the BCG vaccine is achieved through the formation of cellular immunity as a post-vaccination allergy, while with the introduction of the hepatitis B vaccine, humoral immunity is formed.

Studies show that with the introduction of the yeast recombinant vaccine Engerix B in the first 24-48 hours of life and vaccination against tuberculosis on the 4-7th day, no side effects are observed. At the same time, 95.6% of children developed protective immunity against hepatitis B and not There was a noticeable decrease in the level of protection against tuberculosis, which could be judged by the stable incidence of tuberculosis after the start of mass vaccination against hepatitis B

On the other hand, administration of the hepatitis B vaccine immediately after the birth of a child is justified only in cases where there is a high risk of infection of the child during childbirth or immediately after birth, that is, in children born to mothers who are carriers of the hepatitis B virus or patients with hepatitis B, as well as in regions with high levels of HB viral infection. First of all, these are the regions of Siberia, the Far East, the Republic of Tyva, Kalmykia, etc.

Of course, theoretically it can be assumed that if a pregnant woman does not have markers of hepatitis B (HBsAg, anti-HBcory), then vaccination in newborns can be delayed until later in life. But with this approach, it is impossible to guarantee that infection will not occur in the postnatal period: in the fermentation house, in the neonatal pathology department, etc. That is why, in regions with a high level of HBsAg carriage, it is undoubtedly necessary to start vaccination immediately after birth and regardless of whether or not markers of hepatitis B are detected in the mother.

Children from families where there is a carrier of HBsAg or a patient with hepatitis B are also subject to priority vaccination against hepatitis B. According to research, in families where there is a source of infection, markers of HBV infection are found in 90% of mothers, 78.4% of fathers and 78. 3% children. A similar pattern can be seen in orphanages and boarding schools, that is, in institutions where there is close contact and there is a high probability of transmission of infection by so-called contact, through microtraumas, household items, etc. It is better to begin vaccination of sero-negative children in such outbreaks after a mass examination children for markers of hepatitis B. If for some reason it is impossible to determine markers of hepatitis B, vaccination can be carried out without waiting for the results of the examination. However, the negative consequences of administering the vaccine to children (and adults) who have post-infectious immunity or even an active infection should not be exaggerated. The administration of an additional dose of immunizing antigen in the form of a recombinant vaccine should be regarded as a positive rather than a negative factor, since an additional dose of immunizing antigen is known to have a booster effect, and there are practically no adverse reactions.

For this reason, attempts are being made to treat chronic hepatitis B or HBsAg carriage by administering a vaccine against hepatitis B. According to American pediatricians, determining markers of hepatitis B may be more expensive than vaccination itself, since only a positive effect should be expected from the administration of the vaccine; it is more rational to vaccinate without prior expensive laboratory testing.

The order of the Ministry of Health “On the introduction of preventive vaccinations against hepatitis B” provides for mandatory vaccination of patients who regularly receive blood and its preparations, as well as those on hemodialysis. Vaccination in these cases should be carried out four times according to the scheme 0-1-2-6 months, while in patients , on hemodialysis, vaccine vines are doubled.

Vaccination of children against hepatitis B with oncohematological diseases

As is known, patients with hematological malignancies, solid tumors and hemophilia are especially often infected with the hepatitis B virus during treatment.

According to research data, during a single screening examination, markers of hepatitis B are detected in 60.2% of patients with hematological malignancies, in 36.5 - with solid tumors, in 85.2 - with hemophilia, and only in 6% of patients with acute intestinal infection, and in children from families kept at home - in 4.3% of cases. It would seem that patients with hematological malignancies, solid tumors and hemophilia should be vaccinated first, but it is known that in conditions of immunodeficiency, the development of immunity to the vaccine is significantly slowed down or the protective level of antibodies is not formed at all. Our data confirm the low level of protection in response to hepatitis B vaccine in patients with hematological malignancies, but given the high risk of infection and the consequences of infection with the hepatitis B virus, it is recommended to vaccinate against hepatitis B as soon as a diagnosis of cancer is made. Vaccination in such patients should be carried out until protective immunity appears according to the scheme: 0-1-3-6-12 or 0-1-2-3-6-12 months.

Antibodies to the HBs antigen (HBsAg) of hepatitis B virus (HBV) have protective properties. This fact underlies vaccine prevention. Currently, recombinant HBsAg preparations are mainly used as a vaccine against hepatitis B. The effectiveness of immunization is assessed by the concentration of antibodies to HBsAg (antiHBs) in vaccinated individuals. According to WHO, the generally accepted criterion for successful vaccination is an antibody concentration exceeding 10 - mIU/ml.

Vaccination of persons who have had HBV infection is not only not economically feasible, but also means an unjustified antigenic load on the human immune system. Therefore, before starting vaccination, it is necessary to screen persons subject to immunization for the presence of HBsAg, antiHBs, and HBcore antibodies in the blood. The presence of at least one of the listed markers is a disqualification from hepatitis B vaccination.

Despite the fact that modern vaccines are characterized by high immunogenicity, vaccination does not always protect the human body from possible HBV infection. According to literature data, the protective level of antibodies after completion of the vaccination course is not achieved in 2-30% of cases. In addition to the quality of the vaccine, the effectiveness of the immune response is influenced by many factors, the most determining of which is the age of the vaccinated. The maximum immune response in humans is observed between the ages of 2 and 19 years. The weakest immune response to vaccination is typical for people aged 50 years and older. This is also evidenced by data from studies conducted among medical workers of medical organizations in the city of Lipetsk and the region by the clinical and immunological laboratory of the State Healthcare Institution “LOCPBS and IZ” in 2016.

The age-related decline in the immune response is more pronounced in men than in women. Resistance to vaccination can be observed among immunocompetent individuals: HIV-infected people, patients with chronic diseases, etc. In addition, there is data on the influence of the weight of the vaccinee on the magnitude of the immune response.

At the end of the vaccination course (after 1-2 months), it is necessary to monitor the concentration of antiHBs in the blood of vaccinated people. A number of researchers believe that after a full vaccination cycle, the concentration of antiHBs should be 100 mIU/ml or more, since at lower values ​​in vaccinated people there is a rapid decrease in protective antibodies to< 10 мМЕ/мл. Разделяя эту точку зрения, Sherlock и Dooley (1997) выделяют три варианта ответа на вакцинацию против ВГВ:

  • negative result, or vaccination is ineffective,< 10 мМЕ/мл,
  • weak response – from 10 to 99 mIU/ml,
  • a sufficient answer is 100 mIU/ml or more.

A number of studies have shown that if a protective level of antiHBs is not achieved at the end of the vaccination course, a single booster dose of the vaccine one year after the primary course of vaccination can lead to a positive result.

Over time, the concentration of anti-HBs in the blood of many vaccinated people drops below the protective level, and the question of the need for revaccination becomes relevant. Current thinking is that most vaccinated people do not need a booster dose of the vaccine. Thanks to immunological memory, long-term post-vaccination immunity is maintained even in cases where the concentration of anti-HBs decreases to non-protective values. Administration of a booster dose is recommended only for immunocompromised individuals (hemodialysis, chronic renal failure, liver disease, HIV-infected people, etc.)

In the laboratory of the State Health Institution "LOCPBS and IZ" serological blood tests are carried out for the presence of HBsAg, antiHBs, HBcore antibodies.

clinical laboratory diagnostics doctor

    T.A. Bektimirov, M. A. Gorbunov, N. V. Shalunova, L. I. Pavlova
    State Research Institute for Standardization and Control of Medical Biological Preparations named after. L.A. Tarasevich, Moscow

    RESULTS OF REGISTRATION TESTS OF THE VACCINE " Euvax B" FOR THE PREVENTION OF VIRAL HEPATITIS B

    Considering the variety of routes of transmission of hepatitis B and the huge number of sources of this infection (patients with chronic hepatitis, acute forms of infection and especially carriers of HBsAg), the most promising means of preventing this infection is vaccination. Vaccination is the only means of interrupting the natural mechanism of transmission of the virus from a mother carrying HBsAg to a newborn child. In addition, hepatitis B immunization provides protection against hepatitis D virus infection.

    Currently, recombinant yeast vaccines are used to prevent hepatitis B, which are characterized by weak reactogenicity, complete safety and pronounced protective activity. Hepatitis B vaccines, even when administered to newborns in the first hours after birth, are well tolerated and have a pronounced protective effect. In this case, there is no interference with maternal antibodies or with passive antibodies contained in specific immunoglobulin against hepatitis B. There is no interference with other vaccines, including vaccines included in the preventive vaccination schedules. In this regard, vaccines against hepatitis B can be used in combination with almost all vaccines.

    The experience of widespread use of the hepatitis B vaccine in many countries around the world has once again convincingly shown that an effective impact on reducing the intensity of the hepatitis B epidemic process through immunization is possible only with properly developed tactics and strategies for vaccine prevention of this infection.

    Vaccination of persons carried out for many years only from the so-called high-risk groups of infection (medical workers, drug addicts, etc.) in countries such as the USA, France, Germany, etc. did not provide the expected reduction in the incidence of hepatitis B and the level of HBsAg carriage in these countries.

    Based on this, WHO, summarizing many years of experience in using the hepatitis B vaccine, recommended the inclusion of vaccination in national vaccination calendars as the most effective measure for the specific prevention of this infection. Currently, more than 80 countries in Europe, Asia, Africa and the Americas provide combination vaccination against hepatitis B as part of the Expanded Program on Immunization (EPI).

    Many years of experience in using the hepatitis B vaccine as part of national preventive vaccination calendars in a number of countries around the world indicates that this measure reduces the incidence of hepatitis B and the carriage of the virus not only in children and adolescents, but also in the adult population by 10-20 times.

    The full course of vaccination against hepatitis B consists of three vaccinations, which can be carried out according to two schemes: the so-called “short” scheme, in which vaccination is carried out with a monthly interval between vaccinations (0-1-2 months) and the so-called “classic” scheme immunization, in which the third vaccination is carried out 6 months after the first (0-1-6 months). When using a “short” immunization regimen (0-1-2 months), a rapid increase in antibodies occurs, and therefore it is recommended to be used for emergency prevention of hepatitis B (newborns from HBsAg carrier mothers) and in urgent cases of possible infection with the hepatitis B virus during surgical interventions or other parenteral manipulations, as well as when working with blood and its preparations.

    As a rule, after a full course of immunization, the rate of seroconversion in individuals with a protective antibody titer varies from 80 to 100%.

    It should be especially emphasized that only a full course of immunization provides protection against hepatitis B infection, because two vaccinations cause the formation of antibodies in only 50-60% of those vaccinated.

    It has been demonstrated that interchangeability of vaccines produced by different manufacturers is possible. Thus, if one or two doses of one vaccine were used at the beginning of immunization, and the course of immunization was completed with a vaccine from another manufacturer, then the immune response was the same as when using the same drug. However, this approach to immunization should not be routine. It can be used for immunization, in particular, of migrant children in cases where it is impossible to determine which vaccine the child was previously vaccinated with. The duration of preservation of anti-HBs in the blood serum of vaccinated people depends on the magnitude of antibody titers synthesized during the vaccination process, however, protection against the development of a clinically significant form of infection and the formation of chronic carriage persists for a very long period of time even after the disappearance of antibodies. Immunized people with protective titers of post-vaccination antibodies have a rapid immune response when given a booster dose of vaccine or when exposed to HBV, even many years after primary immunization. This indicates long-term preservation of immunological memory, preventing the development of clinical forms of HBV infection or the formation of chronic virus carriage.

    Based on this, there is no need to administer booster doses of the vaccine to children or adults with normal immune status.

    In our country, the domestic vaccine against hepatitis B, as well as three foreign-made vaccines, have been registered and approved for use in healthcare practice.

    The company "Pasteur Merier Connaught" (France) contacted GISC named after. L.A. Tarasevich with a request for the possibility of registration and use of a yeast recombinant vaccine in the Russian Federation " Euvax B" manufactured by LG Chemical Ltd. (Republic of Korea).

    The main objectives of this study were to assess the reactogenicity and immunological activity of the vaccine " Euvax B" with the aim of allowing its use for the prevention of hepatitis B in the Russian Federation.

    Study of reactogenicity and immunological activity of yeast recombinant vaccine " Euvax B"against hepatitis B was carried out under controlled epidemiological experience (field clinical trials) with immunization of adults aged 19-20 years.

    When determining immunological activity, it was established that after a full course of vaccination against hepatitis B according to a shortened immunization schedule (0-1-2 months) in those vaccinated with the vaccine " Euvax B"The seroconversion rate was 92.9 ± 3.4%. There were no statistically significant differences in the seroconversion rate compared to the reference vaccine (table).

    One of the indicators characterizing the immunogenicity of vaccines against hepatitis B is the titer of specific antibodies in vaccinated people. When determining the antibody level using the Roche-Moscow test system, in more than 50% of vaccinated individuals, antibody titers after the full course of vaccination were above 100 mIU/ml (long-term protection titer).

    When using the Hepanostica test system, it was revealed that even with a “short” vaccination regimen, antibody titers in 70-85% of cases exceeded 100 mIU/ml, and in 30-50% of cases - 500 mIU/ml or more.

    Seroconversion and anti-HBs titers in vaccine recipients" Euvax B" and a reference vaccine 1 month after the full course of vaccination (scheme 0-1-2 months, test system "Hepanostica")

    Thus, the tested vaccine" Euvax B"has pronounced immunological activity when used according to the 0-1-2 month regimen. Our results are fully consistent with the materials of field clinical trials of the vaccine" Euvax B", presented by the company.

    The results of laboratory control and field clinical trials, indicating the low reactogenicity and pronounced immunological activity of the yeast recombinant vaccine " Euvax B", allowed us to recommend it for registration in the Russian Federation for the purpose of use for the prevention of hepatitis B.

    Representatives of the Ministry of Health of Russia and the National Authority for the Control of Medical Immunobiological Preparations (L.A. Tarasevich GISC), in accordance with the procedure for registering MIBP in the Russian Federation, inspected the production premises and the department of biological and technological quality control of the hepatitis B vaccine of the LG Chemical Ltd company " (Republic of Korea). The delegation was given full opportunity to familiarize itself with the production and control conditions for compliance with the requirements of a quality manufacturing process (GMP).

    The inspection was carried out in Iksan City, where the main production units are located, and in Daejeon City, where the scientific units and some production departments are located.

    Familiarization with the production conditions showed their very high level. Despite the ten-year service life of the production premises and equipment, they are in excellent condition. The design of the premises, the placement of equipment, ensuring the flow of the technological process, and especially the automation and computerization of most stages of production, as well as electronic and computer monitoring of production processes, allow, according to representatives of Russia, to attribute the production of hepatitis B vaccine to LG Chemical Ltd. to the category of the most modern MIBP production facilities.

    It should also be noted that microbiological monitoring of production facilities ensures aseptic conditions for vaccine production. There is also no doubt about the high competence of the staff, who regularly improve their qualifications.

    In general, the company has a carefully designed quality assurance system that fully satisfies the requirements of GMP and quality control of the hepatitis B vaccine.

    The work of the biological and technological control department, which is equipped with modern equipment, deserves full approval.

    The test results allowed the company to issue "LG Chemical Ltd." GMP certificate for the production of hepatitis B vaccine.

The high cost of treating patients (second only to tetanus and polio) and the great social significance of the disease give reason to consider the prevention of hepatitis B a priority. The most promising means of combating the disease is vaccination against hepatitis for newborns, children, adolescents and adults at risk. In case of contact with material infected with HBV viruses, emergency prophylaxis is carried out.

The main measures to prevent the disease are:

  • Virus inactivation.
  • Preventing new cases of the disease.
  • Immunoprophylaxis (active and passive immunization).

Viral hepatitis B is a highly contagious infectious disease widespread throughout the world. The disease claims the lives of hundreds of thousands of patients every year. Its spread is facilitated by the multiplicity of transmission routes, the high resistance of viruses in the external environment and the general susceptibility of the population of all ages to infection.

Rice. 1. The photo shows HBV viral particles.

Virus inactivation

Inactivation of HBV viruses is achieved through the use of various methods of sterilization and disinfection, which are regulated by a number of relevant orders and instructions.

  • Viruses are inactivated within 10 - 20 minutes when boiling, within 2 hours or more when dry heated to 180 0 C, within 20 minutes when exposed to steam, within 45 minutes when autoclaving at t o
  • Viruses are destroyed in alkaline environments. Hydrogen peroxide, formaldehyde, glyoxal, chlorine compounds and phenol have a detrimental effect on them.

Rice. 2. Autoclaving of a medical instrument guarantees the destruction of pathogenic microorganisms.

Nonspecific prevention of hepatitis B

Nonspecific prevention of the disease consists of preventing the emergence of new cases of infection, which occurs during therapeutic and diagnostic procedures (injections, blood transfusions, hemodialysis, invasive studies, transplantations, etc.), during sexual intercourse, transmission of infection from mother to child, in everyday life, when using unsterile syringes and needles by drug addicts and when applying tattoos, piercings and acupuncture. For HBV infection, a minimal (0.1 - 0.5 µm) amount of blood is sufficient.

  • Prevention of infection with viruses in everyday life is achieved by observing basic hygiene rules. You should not use other people's toothbrushes, razors, washcloths, towels, massagers, etc.
  • The use of condoms reliably prevents sexual transmission of infection.
  • Prevention of infection during blood transfusion is achieved by conducting a laboratory examination of the blood of all donors to detect viral antigens - HBsAg. Persons who have had hepatitis B in the past and have been in contact with patients over the past 6 months are excluded from donation.
  • Prevention of infection during therapeutic and diagnostic parenteral procedures is achieved through the widespread introduction and improvement of centralized sterilization of medical devices and the use of disposable syringes.
  • Prevention of occupational infection in medical institutions is achieved through strict adherence to the rules of the anti-epidemic regime in departments where medical personnel have contact with blood (hemodialysis departments, surgical, laboratory, etc.).

Rice. 3. Prevention of HBV infection through blood transfusion is achieved by conducting laboratory testing of the blood of all donors to detect viral antigens.

Specific prevention: vaccination against hepatitis B

Mass immunization of the population is an essential component of the fight against the disease. Vaccination against hepatitis B not only prevents the development of acute infection, but also complications of the disease in the form of the development of chronic forms (95% of cases), liver cirrhosis and hepatocellular carcinoma. Protection against HBV viruses lasts about 20 years. Vaccination is the only means of preventing hepatitis B in newborns. In the Russian Federation, hepatitis vaccinations are included in the national vaccination calendar. They are carried out for newborns and then for all unvaccinated children and adolescents, as well as adults at risk.

Hepatitis B vaccine

To carry out active immunization, 2 types of vaccines have been developed:

  1. Prepared from patient plasma, which contains HBV antigens.
  2. Recombinant vaccines, which are obtained by genetic engineering using cultures of baker's yeast (Saccharomyces cerevisiae). They contain highly purified HbsAg. The effectiveness of these drugs is 85 - 95%.

Vaccination against hepatitis B in the Russian Federation is carried out with both imported and domestic vaccines.

  • Imported vaccines: Engerix-B (Belgium, Russia), HBVax-II (USA), Euvax B (South Korea), Rec-HbsAg (Cuba).
  • Domestic vaccines: Engerix-B, Combiotech, NPO Virion vaccine, Regevak B, Twinrix (for hepatitis A and B), etc.

All drugs are interchangeable. They are used in children and adults. One vaccination dose contains 10 or 20 μg of highly purified surface HbsAg. Vaccines induce the formation of Hbs antibodies. After their administration, long-term (5 - 12 years) immunological memory is formed.

Hepatitis B vaccination

A mandatory condition for vaccination is the absence of markers of HBV infection in patients.

Contraindications. A contraindication to hepatitis B vaccination is an allergy to vaccine components, including yeast, and/or a reaction to a previous vaccine.

Side effects. Side effects are extremely rare, mild and temporary. Sometimes redness and thickening develop at the injection site.

Vaccine dose and technique. The vaccine is injected into the deltoid muscle in adults and children, and into the muscle of the anterolateral thigh in newborns. For adults, the drug is administered in a dose of 10 - 20 mcg, for children - 2.5 - 10 mcg.

In individuals who do not respond to the standard dose of the vaccine, the vaccination dose may be increased to 40 mcg. If multiple vaccines are needed, the hepatitis B vaccine is injected into a different area using a separate syringe.

Rice. 4. Hepatitis B vaccines.

Vaccination against hepatitis B for newborns

Newborn vaccination schedule:

  • Newborns receive the first dose of the vaccine on the first day of life before birth.
  • The second - at 1 - 3 months of the child’s life.
  • The third - at the 6th month of the child’s life.

Children born to HBsAg-positive mothers are given specific Ig at the same time as the first vaccine.

Vaccination schedule for children at risk:

  • Newborns receive the first dose of the vaccine on the first day of life.
  • The second - after 1 month.
  • The third - 2 months after the first vaccination.
  • The fourth - in 12 months.

Rice. 5. Vaccination against hepatitis B is the only means of preventing the disease in newborns.

Hepatitis B vaccination for children and adolescents

Previously unvaccinated children and adolescents should receive the vaccine by age 18. Vaccination is carried out for children living with carriers of the infection or persons suffering from chronic hepatitis, regularly receiving blood and its preparations, undergoing hemodialysis, persons from boarding schools and orphanages. Vaccination of adolescents is aimed at preventing sexual transmission and infection through drug use. Protective vaccinations are carried out at intervals of 1 month and the third vaccine is administered 5 months after the second.

Rice. 6. Vaccination for children is carried out according to the schedule 0 - 1 - 3 and 6 months.

Hepatitis B vaccine for adults

Vaccine prevention among the adult population is carried out in high-risk groups, which include:

  • Medical workers.
  • Students of medical colleges and universities.
  • Patients on hemodialysis, receiving blood transfusions, patients in oncology hospitals.
  • Drug addicts.
  • Contact persons from the environment of HBV carriers and patients with chronic hepatitis.
  • Persons involved in the production of placental blood and immunobiological preparations from donor blood.
  • Children and staff of orphanages and boarding schools.

Due to the fact that most cases of viral hepatitis B among medical workers occur in persons with work experience of no more than 5 years, vaccination should be carried out before the start of their professional activities.

When immunized, adults receive 2 vaccinations during the 1st month and a third vaccination after 6 months (0 - 1 - 6). For patients in hemodialysis departments, the vaccine is administered 4 times with a one-month break.

Rice. 7. Vaccinations for adults are carried out in high-risk groups for the disease.

Emergency prevention of disease

Emergency prevention is carried out in case of contact with material infected with HBV, which occurs when the skin is damaged by instruments contaminated with blood or tissue fluid, during sexual contact with patients or newborns born from HBsAg-positive mothers. Preventive measures include the combined use of immunoglobulin and hepatitis B vaccine. Serum immunoglobulin preparations for passive immunization are used with an anti-HBs titer of at least 200 IU/l. The combination of vaccines and immunoglobulin has a protective effect of more than 95%.

  • Immunoglobulin for newborns is administered in a dose of 0.5 ml into the anterolateral thigh, the vaccine is administered into the opposite thigh during the first 12 hours after birth. Subsequent administration is carried out after 1 and 6 months.
  • Immunoglobulin for adults is administered at a dose of 0.04 - 0.07 ml per 1 kg of weight into the deltoid muscle. Active immunization is carried out simultaneously or in the near future by administering 10 - 20 mcg of vaccine, followed by revaccination after 1 and 3 months.

Rice. 8. Immunoglobulins contain antibodies to the surface antigen of the hepatitis B virus. They block viral receptors, thereby reducing the risk of infection.

Epidemiological surveillance and anti-epidemic measures

Epidemiological surveillance of viral hepatitis B includes recording and analysis of all cases of the disease, serological monitoring, assessment of the effectiveness of vaccination and other preventive measures, and their socio-economic significance.

Anti-epidemic measures in case of disease are carried out at the source of infection and are aimed at three parts of the epidemic process:

  • Early identification of sick and infected people.
  • Isolation in hospital.
  • Carrying out final and ongoing disinfection.
  • Identifying contact persons and conducting emergency immunization.
  • Dispensary observation of persons who have had the disease.

In the outbreak of acute and chronic hepatitis B, in the event of hospitalization, discharge or death of the patient, final disinfection is carried out. Current disinfection consists of strictly individual use of personal hygiene items by the patient and their ongoing disinfection by boiling and treatment with disinfectant solutions.

Rice. 9. Patients in the acute period of the disease are hospitalized in a specialized institution.

Hepatitis B virus causes serum hepatitis (viral liver disease). Its outcome is difficult to predict. In severe and weakened patients, infection occurs:

  • during blood transfusion,
  • through syringes,
  • sexually.

Until recently, there was no publicly available vaccine against this virus. It does not propagate in vitro in tissue culture. Reproduction occurs only in the patient's body. Therefore earlier the only way its receipt was the isolation of viral particles from the blood of sick people, and the only vaccine Antibodies isolated from the blood serum of virus carriers were used. These antibodies were used for passive immunization of patients with acute hepatitis.

The blood plasma of infected people contains varying amounts of particles of different sizes and shapes:

  • spherical and filamentous particles with a diameter of about 22 nm, which are devoid of DNA and are the shells of the virus;
  • Dane particles with a diameter of 42 nm (they are less common) are virions and consist of an envelope and a nucleocapsid with a diameter of 27 nm containing DNA molecules.

Preparations of purified nucleocapsids serve source of material to prepare a vaccine, their immunochemical properties are being intensively studied.

The hepatitis B virus belongs to the hepadnavirus family.

Its capsid is of a lipoprotein nature, which includes the surface Hbs protein and Hbs aptigen (HbsAG). The viral envelope probably consists of a lipid bilayer containing polypeptide dimers, which contain intermolecular and intramolecular disulfide bonds that determine the tertiary and quaternary structure of the protein, as well as the antigenic and immunogenic properties of HbsAG. Virions contain a nucleotide formed by the nuclear protein HbcAG. The plasma of infected people also contains another antigen - HbeAG. Viral DNA includes 3,200 nucleotides and consists of two chains:

  • one of which is long (L), with a fixed length,
  • the other is short (S), with varying length.

Transmission of the hepatitis B virus, either naturally or experimentally, occurs only in chimpanzees and humans. It cannot be propagated in tissue culture, and experiments with several types of laboratory animals have been unsuccessful.

Thus, the study of the biology of the virus was complicated by its narrow specialization. Its genome was cloned and introduced (in whole or in parts) into cell lines, after which gene expression was studied. Thus, in 1980, Dubois and his colleagues achieved success by introducing viral DNA into L-cells of mice. They found that viral DNA was integrated into cellular DNA and that HbsAG particles were secreted into the culture medium without lysis of mouse cells.

In 1981, Mariarti and his collaborators created hybrid DNA molecule, containing the DNA of the SV40 virus and a DNA fragment of the hepatitis B virus. When introduced into the kidney cells of monkeys, it caused the synthesis of HbsAG particles. Viral DNA cloning in E. coli cells and its subsequent introduction into mammalian cell lines made it possible to overcome some of the difficulties caused by the lack of an in vitro system for virus propagation.

On the other hand, the synthesis of HbsAG in prokaryotic and eukaryotic cells using cloned viral DNA would likely help produce other types of antigens, perhaps more economical and safe for vaccine production. Thus, Rutter (USA) obtained yeast cells that form glycosylated surface antigen. The Hbc protein was also obtained, isolated from viral particles and synthesized under the control of recombinant DNA in bacteria. This protein protected chimpanzees from subsequent hepatitis B virus infection.

Use of recombinant DNA technology to obtain vaccines - a step towards the development of synthetic vaccines. Several groups of researchers have synthesized immunogenic peptides that may lead to the development of a synthetic vaccine against hepatitis B. These are two cyclic peptides that were administered intraperitoneally to mice using various adjuvants. 7 - 14 days after immunization, antibodies to the surface of the hepatitis B virus were detected.