Hepatitis B

Active Ingredient: Hepatitis B, purified antigen

Indication for Hepatitis B, purified antigen

Population group: only minors (0 - 18 years old)
Therapeutic intent: Preventive action

Hepatitis B vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis B virus.

The specific at risk categories to be immunised are to be determined on the basis of the official recommendations.

It can be expected that hepatitis D will also be prevented by immunisation with hepatitis B vaccine as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

For this indication, competent medicine agencies globally authorize below treatments:

3-4 0.5 ml injections as a primary immunisation schedule

For:

Dosage regimens

Regimen A: Intramuscular, 0.5 milliliters hepatitis B, purified antigen, once monthly, 2 doses in total, over the duration of 6 months. Afterwards, intramuscular, 0.5 milliliters hepatitis B, purified antigen, one dose.

Regimen B: Intramuscular, 0.5 milliliters hepatitis B, purified antigen, once monthly, 3 doses in total, over the duration of 12 months. Afterwards, intramuscular, 0.5 milliliters hepatitis B, purified antigen, one dose.

Detailed description

Individuals from birth through 15 years of age: 1 dose (0.5 ml) at each injection.

Primary vaccination

A course of vaccination should include at least three injections.

Two primary immunisation schedules can be recommended:

0, 1, 6 months: two injections with an interval of one month; a third injection 6 months after the first administration.

0, 1, 2, 12 months: three injections with an interval of one month; a fourth dose should be administered at 12 months.

It is recommended that the vaccine be administered in the schedules indicated. Infants receiving the compressed regimen (0, 1, 2 months dosing schedule) must receive the 12 month booster to induce higher antibody titres.

Booster

Immunocompetent vaccinees

The need for a booster dose in healthy individuals who have received a full primary vaccination course has not been established. However, some local vaccination schedules currently include a recommendation for a booster dose and these should be respected.

Immunocompromised vaccinees (e.g. dialysis patients, transplant patients, AIDS Patients)

In vaccinees with an impaired immune system, administration of additional doses of vaccine should be considered if the antibody level against hepatitis B virus surface antigen (anti-HBsAg) is less than 10 IU/l.

Revaccination of nonresponders

When persons who do not respond to the primary vaccine series are revaccinated, 15-25% produce an adequate antibody response after one additional dose and 30-50 % after three additional doses. However, because data are insufficient concerning the safety of hepatitis B vaccine when additional doses in excess of the recommended series are administered, revaccination following completion of the primary series is not routinely recommended. Revaccination should be considered for high-risk individuals, after weighing the benefits of vaccination against the potential risk of experiencing increased local or systemic adverse reactions.

Special dosage recommendations

Dosage recommendation for neonates of mothers who are hepatitis B virus carriers:

  • At birth, one dose of hepatitis B immunoglobulin (within 24 hours).
  • The first dose of the vaccine should be given within 7 days of birth and can be administered simultaneously with hepatitis B immunoglobulin but at a separate injection site.
  • Subsequent doses of vaccine should be given according to the locally recommended vaccination schedule.

Dosage recommendation for known or presumed exposure to hepatitis B virus (e.g. needlestick with contaminated needle):

  • Hepatitis B immunoglobulin should be given as soon as possible after exposure (within 24 hours).
  • The first dose of the vaccine should be given within 7 days of exposure and can be administered simultaneously with hepatitis B immunoglobulin but at a separate injection site.
  • Serologic testing is also recommended, with the administration of subsequent doses of vaccine, if necessary, (i.e. according to the serologic status of the patient) for short and long term protection.
  • In the case of unvaccinated or incompletely vaccinated individuals, additional doses should be given as in the recommended immunisation sched

Dosage considerations

This vaccine should be administered intramuscularly.

The anterolateral thigh is the preferred site for injection in neonates and infants. The deltoid muscle is the preferred site for injection in children and adolescents.

Do not inject intravascularly.

Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopaenia or bleeding disorders.

Active ingredient

Hepatitis B, purified antigen

Hepatitis B vaccine induces specific humoral antibodies against hepatitis B virus surface antigen (anti-HBsAg). Hepatitis B vaccine has been recognized as the first anti-cancer vaccine because it can prevent primary liver cancer.

Read more about Hepatitis B, purified antigen

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