Hepatitis B vaccine

The incidence of acute hepatitis B in Russia, rising before the beginning of this century, is reduced from 42 per 100,000 inhabitants in 2001 to 5.26 in 2007. In childhood, there was an even more dramatic decrease in incidence.

The rapid decline in incidence is a consequence of high hepatitis B vaccine coverage in newborns and adolescents. Nevertheless, the high incidence in the past will be felt for a long time: the number of newly diagnosed cases of chronic hepatitis is much higher than the number of acute hepatitis B: in 2004 it was about 75,000 with 15,000 acute, in 2006 respectively 20,000 and 10,000 To this should be added 68,000 newly identified carriers of the hepatitis B virus. In children in 2006, chronic hepatitis revealed 417 cases and 1,700 carriers. HBsAg.

The total number of carriers of hepatitis B in Russia exceeds 3 million people. About 90% of newborns from mothers of HBeAg are infected during childbirth, in the case of mother carrier only HBsAg, the risk of vertical transmission of the virus to the newborn is lower, but they all have a high risk of infection during breastfeeding and close contact with the mother. In newborns, hepatitis B in 90% of cases takes a chronic course, with infection in the first year of life - in 50%, in adults - in 5-10%. Therefore, the importance of preventing the vertical route of infection with hepatitis B by administering hepatitis B vaccination to children on the first day of life is obvious. This is in line with the WHO strategy.

Vaccination against hepatitis B on the 1st day of life by 2005 was introduced in 80% of countries, including those with low endemicity of HBV infection (USA, Switzerland, Italy, Spain, Portugal). Relying on the test results of pregnant women on HBsAg and vaccinating only children from mothers is unreliable: as studies conducted in Russia showed, with the help of a routine test, about 40% of carriers were not detected (nationwide, 8-10 thousand children) - and this very high quality of examination (only 0.5% of errors). Therefore, it is quite legitimate to preserve the 1st vaccination against hepatitis B in the first 12 hours of a child’s life, as stipulated by the 2007 National Calendar. The same measure was introduced in the USA since 2006, since about 2 thousand children are born there every year from mothers of HBsAg not identified in the prenatal period.

Objections against vaccination on the first day of life were reduced to the complexity of its organization, as well as to a possible reduction in coverage with other vaccinations. Studies, on the contrary, have shown that hepatitis B vaccination at birth increases the rate of completion in time of both this vaccination course and other calendar vaccines. The interaction of BCG and HBV administered in the neonatal period was not confirmed either in size. Mantoux, neither by the size of the vaccinal scar, nor by the level of antibodies to HBsAg, nor by the number of complications. Cases of bleeding from the injection site of the 2nd dose of viral hepatitis B in one of the regions were due to hemorrhagic disease of newborns who had not received vitamin K preventively.

Vaccination against hepatitis B on the 1st day of a child's life does not increase the injection load, since according to the scheme of 0-3-6 months, the use of combined vaccines is possible.

[1], [2]

Objectives of Hepatitis B Vaccination Programs

The goal of the WHO European Bureau for Hepatitis B is “By 2005 or earlier, all countries should have reached 90% coverage with 3 Hepatitis B vaccinations in groups subject to total vaccination” in Russia. The reduction in incidence through mass vaccination is impressive. The experience of Taiwan and South Korea shows that mass vaccination of newborns dramatically reduces the incidence of liver cancer in children. Mass vaccination of all persons up to 55 years of age will create conditions for stopping the transmission of infection, the reservoir of which is a large number of carriers of HBsAg and patients with chronic hepatitis B.

[3], [4], [5],

Hepatitis B vaccine: vaccines

Gene-engineered vaccines inactivated, contain only vaccine protein. They are adsorbed on aluminum hydroxide, the preservative is not used in some vaccines, they should be vaccinated in newborns. Combined HBV + DTP vaccines are preferred at 3 and 6 months of age. The HBV + ADS-M vaccine in adults will allow a combination of hepatitis B vaccination and planned revaccination against diphtheria. Vaccines are stored at 2-8 ° C.

Hepatitis B vaccines are highly immunogenic, antibodies in protective titers are formed in 95-99% of those vaccinated with a protection duration of 8 years or more. Premature babies weighing less than 2 kg can give a weakened immune response, they are vaccinated from the age of 2 months. If the mother is a carrier of the virus, the vaccination is carried out on the first day of life with the simultaneous introduction of 100 IU of specific immunoglobulin. Immunoglobulin is also used for post-exposure prophylaxis. Seroconversion to the hepatitis A virus with the use of the vaccine Twinx reaches 89% after 1 month. After the first dose and 100% after the second, to the hepatitis B virus - in 93.4% after 2 months. And 97.7% after 6 months.

[6], [7], [8], [9], [10]

Methods and schemes for vaccination against hepatitis B

All vaccines are intended for both children and adults, including risk groups, they are administered in age doses intramuscularly. All vaccines are interchangeable. Since 2008, children of the 1st year have been vaccinated according to the scheme of 0-3-6 months, children of risk groups - according to the scheme of 0-1-2-12 months. Unvaccinated children, adolescents and adults are vaccinated according to the scheme 0-1-6. Emergency vaccination (for example, before surgery with massive blood transfusion) with Endzheriks B vaccine is carried out according to the scheme of 0-7-21 days with revaccination after 12 months. Lengthening the interval before the second dose is possible up to 8-12 weeks, but in risk groups it is better to limit it to 4-6 weeks. The timing of the introduction of the third dose can vary even more - up to 12-18 months. After the first dose. When combined vaccines are used, 0-2-6 months regimens are justified. And 0-3-6 months, they are used in Spain, USA, Kazakhstan.

Hepatitis B monovaccines registered in Russia

Vaccine	Content Preservative	Dosage
Recombinant yeast Combiotech, Russia	20 mcg in 1 ml. Available with and without merthiolate.	Introduced to persons over 18 years old 20 mcg (1 ml), up to 18 years old - 10 mcg (0.5 ml). A double adult dose of 2.0 ml is administered to individuals on hemodialysis.
Regevak, CJSC "MTX", Russia	20 mcg in 1 ml, preservative - mertiolate 0.005%.
Biovac-V, Vokhard Ltd.,	20 mcg in 1 ml, preservative - merthiolate 0.025 mg
Eberbiovac NV, Center for Genetic Engineering, Cuba	20 mcg in 1 ml, contains 0,005% thimerosal
"Endzheriks V" Russia; SmithKline Beecham Biomed,	Particles (20 nm) coated with lipid matrix - 20	The same, but from 16 years
Hep B Recombinant Vaccine (rDNA) Serum Institute Ltd, India	20 mcg in 1 ml, preservative - merthiolate	Introduced to persons older than 10 years 20 mcg (1 ml), up to 10 years - 10 mcg (0.5 ml)
Shanvak-V, Shanta Biotechnology PTV Ltd, India	20 mcg in 1 ml, preservative - merthiolate 0.005%
Evuks V, LG Life Sciences, South Korea under the control of sanofi pasteur	20 mkg in 1.0 ml, merthiolate not more than 0.0046%	It is administered to persons older than l6 years 20 mcg (1.0 ml)), the children's dose is 10 mcg (0.5 ml)
NVBax II, Merck Sharp Dome, The Netherlands	5 μg in 0.5 ml, 10 μg / ml - 1 and 3 ml, 40 μg / ml - 1.0 ml (for persons on hemodialysis). No preservative	Adults 10 mcg, adolescents 11-19 years old - 5 mcg, children under 10 years old - 2.5 mcg. Children mothers carriers - 5 µg

GEP-A + B-in-VAK is used for simultaneous vaccination against hepatitis A and B for children over 3 years old and adults according to the scheme 0-1 -6 months, Twirix - from the age of 1 year according to the same scheme or urgently (0-7 -21 day + quarter dose in 1 year).

In a number of countries, children born from HBsAg-positive mothers are recommended to administer (to another place) a specific immunoglobulin in a dose of 100 IU simultaneously with vaccination, which increases the efficiency by 1-2%; This scheme should be kept in mind in children whose mothers along with HBsAg also have HBeAg.

Revaccination. After vaccination, antibodies can persist for up to 20 years and pain can be protected by immunological memory, even in the absence of antibodies. Therefore, WHO does not recommend revaccination, for at least 10–15 years, it is indicated only to health workers (every 7 years) and people at risk (hemodialysis, immunodeficiency).

Serological screening before vaccination is not required, because The introduction of a vaccine to carriers of HBsAg is not dangerous, and for those who have antibodies to the hepatitis B virus, vaccination may play the role of a booster. Testing for the presence of antibodies is justified in risk groups (immunodeficiency, children from mothers of the carrier) after 1 and 3 months. After the last dose; at the anti-HBs level below 10 mIU / ml, another 1 dose of vaccine is administered.

Combined vaccines registered in Russia

Vaccine	Content Preservative	Dosage
Bubo-M-diphtheria-tetanus-hepatitis V, Kombiotekh JSC, Russia	In 1 dose (0.5 ml) of 10 µg HBsAg, 5 LF diphtheria and 5 EC of tetanus toxoids, the preservative is 2-phenoxy-ethanol, mertiolate 0.005%	Used to vaccinate persons over 6 years old.
Bubo-Kok - pertussis-diphtheria-tetanus-hepatitis V, JSC Combiotech, Russia	In 1 dose (0.5 ml) 5 µg of HBsAg, 10 billion of pertussis microbes, 15 LF of diphtheria and 5 EC of tetanus toxoids, the preservative is merthiolate 50 µg	Used in children under 5 years old
Twinriks - hepatitis A and B vaccine, Gpaxo SmithKline, England	20 µg HBsAg +720 USHEH AGAA in 1.0 ml (adult vaccine) preservative - 2-phenoxyethanol, formaldehyde less than 0.015%	An adult (1.0 ml) is administered to persons over 16 years of age; children from 1 to 15 years old - a child dose (0.5 ml) of the vaccine.
Hep-A + B-in-VAK - Hepatitis A + B Divaccine, Russia	In 1 ml - 80 units of ELISA AG AHA and 20 µg HesAg (in the registration phase)	Introduce 1.0 ml to persons over 17 years old, 0.5 ml - to children of 3-17 years old.

[11], [12], [13], [14], [15], [16], [17], [18], [19], [20], [21],

Vaccination reactions and complications

Vaccinations against hepatitis B are not very reactive; in a part of those vaccinated (up to 17%), hyperemia and induration at the injection site may develop, a short-term impairment of health a rise in temperature is noted in 1-6%. Differences in the frequency of reactions, intercurrent morbidity and physical development with the introduction of DTP + OPV + HBV at the 1st year of life and only DTP + OPV were not detected.

Since 1980, more than 1 billion doses of hepatitis B vaccines have been administered, with isolated cases of anaphylactic shock (1: 600 000), urticaria (1: 100 000), rashes (1:30 000), joint pain, myalgia, erythema nodosum. An anaphylactoid reaction was sometimes observed in a child with yeast intolerance (bread allergy). A case of mesangial-proliferative type IgA glomerulonephritis with HBsAg deposition in the glomerulus and tubules, which began with hematuria 2 weeks after the 2nd dose of HBV, is described.

Publications about the relationship of hepatitis B immunoprophylaxis with the development of multiple sclerosis and other demyelinating diseases with repeated scrutiny were rejected, most likely the hypothesis of coincidence in time of debut of multiple sclerosis and vaccination.

Reactogenicity of Bubo-Kok is comparable to DTP, Twinarix is also a little reactive. On the introduction of a specific immunoglobulin, redness may develop at the injection site and temperatures up to 37.5.

Contraindications for vaccination against hepatitis B

Hypersensitivity to yeast and other components of the drug, decompensated forms diseases (cardiology) of diseases of the cardiovascular system and lungs. Persons with acute diseases are vaccinated with infectious diseases after recovery.

[22], [23], [24], [25], [26],

Post-exposure prophylaxis of hepatitis B

Vaccination against hepatitis B prevents infection when given early in the period after contact. Unvaccinated health workers and other persons who had contact or possible contact with the blood or discharge of a patient, carrier or person with an unknown status (always treated as a carrier of HBsAg) should be vaccinated on the 1st day, preferably with the simultaneous administration of a specific immunoglobulin (no later than 48 h) in different parts of the body in a dose of 0.12 ml (at least 6 IU) per 1 kg of body weight. The vaccination scheme is 0-1-2-6 months, preferably with control of hepatitis markers (not earlier than 3-4 months after the administration of immunoglobulin). In a previously vaccinated health worker, the level of antibodies should be immediately determined upon contact; with titers of 10 mIU / ml and above, prophylaxis is not carried out; in the absence, 1 dose of vaccine and immunoglobulin is administered (or 2 doses of immunoglobulin with an interval of 1 month).

The sexual partner of a patient with acute hepatitis B, if he does not have hepatitis markers, should receive 1 dose of a specific immunoglobulin (its effect is unlikely to last more than 2 weeks) and immediately start vaccination. The effectiveness of this measure is estimated at 75%.

Partially vaccinated infants from family contact with acute hepatitis B should continue the initiated vaccination on the calendar. Not vaccinated, you should enter 100 IU of specific immunoglobulin and vaccine. The rest of the contact persons are vaccinated, but those of them who have had contact with the patient's blood are recommended the same measures as medical workers.

[27], [28], [29], [30],

Hepatitis B vaccination in persons with chronic and hematologic diseases

Persons with chronic diseases can be vaccinated in the period of remission, there is experience of vaccination against hepatitis B in children with chronic glomerulonephritis, chronic broncho-pulmonary diseases, etc. A special indication is chronic hepatitis C.

In case of oncohematological diseases requiring repeated blood transfusions, administration of the hepatitis B vaccine in the acute period does not cause an adequate immune response, although repeated inoculation of othepatitis B ultimately leads to seroconversion in more than 60% of cases. Therefore, one should begin with passive protection with a specific immunoglobulin, vaccinating during the period of remission.

[31], [32], [33],