Hepatitis B Vaccine

Registered South African indications:

• Active immunisation against hepatitis B virus infection

Contraindications 

• Hypersensitivity to the active ingredient or any of its excipients
• Acute severe febrile illness or acute infection

Cautions

• Pregnancy
• Breastfeeding
• Severe renal impairment
• Hypersensitivity to latex
• Immunocompromised patients
• Hepatitis A, C and E carriers
• Male gender
• Obesity
• Smokers
• Premature infants

Forms avail. in SA and covered in this monograph: inj

Active immunisation against hepatitis B virus infection in subjects who are at increased risk of infection
- Health care personnel
- Patients receiving frequent blood transfusions or clotting factor concentrates
- People in close contact with high risk groups (residents of institutions or prisons)
- People at increased risk due to sexual practices
- Illicit users of injectable drugs
- Travellers to high endemicity areas and their close contacts
- Household contact of any of the aforementioned groups and of patients with acute or chronic hepatitis B infection

• IM: 20μg of antigen protein in 1ml suspension; Immunisation schedule: 0, 1 and 6 months OR 0, 1, 2 and 12 months  

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See additional prescribing points

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In adults, injection should be given in the deltoid region

Exceptionally the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders

Do not administer IV, intradermally, or in the buttock

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Known or presumed exposure to HBV: 1st dose coadministered with hepatitis B immunoglobulin (at separate injection site)

Paed. forms avail. in SA and covered in this monograph: inj

EPI Schedule 2016

Active immunisation against hepatitis B virus infection in subjects who are at increased risk of infection
- Patients receiving frequent blood transfusions or clotting factor concentrates
- People in close contact with high risk groups
- Travellers to high endemicity areas and their close contacts
- Household contact of any of the aforementioned groups and of patients with acute or chronic hepatitis B infection
- Infants born to carrier mothers

Neonates 

• IM: 10μg of antigen protein in 0.5ml suspension; Immunisation schedule: 6, 10 and 14 weeks of age

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Administer on opposite limb to that for the DPT/Td injection

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Between 1 month - 10 years

• IM: 10μg of antigen protein in 0.5ml suspension; Immunisation schedule: 0, 1, 2 and 12 months OR 0, 1 and 6 months

Between 11-15 years

• IM: 20μg of antigen protein in 1ml suspension; Immunisation schedule: 0 and 6 months

OR 

• IM: 10μg of antigen protein in 0.5ml suspension; Immunisation schedule: 0, 1, 2 and 12 months  

Older than 15 years

• See adult dosage

Neonates born of mothers who are HBV carriers

• IM: 10μg of antigen protein in 0.5ml suspension, 1st dose 12hrs after birth; Immunisation schedule: 0, 1, 2 and 12 months OR 0, 1 and 6 months; Hepatitis B immune globulins should be given simultaneously at a separate injection site

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See additional prescribing points

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It is preferable to inject into the anterolateral thigh in neonates and infants

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Exceptionally the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders

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Do not administer IV, intradermally, or in the buttock or intradermally

Pregnancy

• Caution
• The effect of the hepatitis B vaccine on foetal development has not been assessed. However, as with all inactivated viral vaccines, one does not expect harm for the foetus. Hepatitis B vaccine should be used during pregnancy only when clearly needed, and the possible advantages outweigh the possible risks for the foetus

Breastfeeding

• Caution
• The effect on breastfed infants of the administration of hepatitis B vaccine to their mothers has not been evaluated in clinical studies, as information concerning the excretion into the breast milk is not available. No contraindication has been established

Renal Impairment

• eGFR ≥11-89ml/min: No dose adjustment recommended
• eGFR <10ml/min: Caution; no dose adjustment recommended
  Serologic testing (anti-HBs titer) is recommended 1 to 2 months after the final dose of the primary vaccine series and annually to determine the need for booster doses
  Patients with chronic renal disease should be vaccinated as early as possible, ideally before they require haemodialysis
  Paediatric patients on scheduled haemodialysis often respond poorly to hepatitis B vaccination. The anti-HBs titer response of such persons should be tested after they are vaccinated. Children who have not responded (low post-vaccination titer) should be revaccinated with 1 to 3 additional doses

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Irritability
• Drowsiness
• Headache
• Dizziness
• Syncope
• Paraesthesia
• Encephalitis
• Encephalopathy
• Convulsions
• Paralysis
• Neuritis
• Neuropathy
• Hypoaesthesia
• Myelitis
• Demyelinating disease of the central nervous system
• Malaise

Cardiovascular Disorders

• Vasculitis
• Hypotension

Respiratory Disorders

• Bronchospasm-like symptoms

Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhoea
• Abdominal pain

Endocrine and Metabolic Disorders

• Decreased appetite  

Musculoskeletal Disorders

• Myalgia
• Arthralgia
• Arthritis
• Muscular weakness
• Pain in extremity

Skin and Subcutaneous Tissue Disorders

• Urticaria
• Pruritus
• Rash
• Erythema multiforme
• Angioneurotic oedema
• Lichen planus
• Erythema
• Alopecia
• Eczema
• Swelling at injection site
• Injection site reaction  
• Pain and redness at injection site

Immune, Blood and Lymphatic System Disorders

• Lymphadenopathy
• Thrombocytopenia
• Anaphylaxis
• Allergic reactions  
• Serum sickness
• Polyarteritis nodosa
• Fever  

Sensory Disorders

• Uveitis

If different syringes and other injection sites are used, no interaction will be observed with concomitant vaccination

None routine

Immunization schedule

All patients

A 0, 1 and 6 months schedule gives optimal protection at month 7 and produces high antibody titres. 

An accelerated schedule, with immunisation at 0, 1 and 2 months, will confer protection more quickly and is expected to provide better patient compliance. With this schedule, a booster should be administered at 12 months as titres after the third dose are lower than those obtained after the 0, 1, 6 months schedule. In infants this schedule will allow for simultaneous administration of hepatitis B with other childhood vaccines.

Between 11-15 years

20μg vaccine can be used in patients between 11-15 years as a 2-dose schedule in situations when there is a low risk of hepatitis B infection during the vaccination course and when compliance with the complete vaccination course can be assured. If both conditions cannot be assured, the accelerated (or 3 dose) schedule of 10μg should be used.

Older than 18 years

In exceptional circumstances in adults, where a more rapid induction of protection is required, a schedule of 3 IM injections given at 0, 7 and 21 days may be used; A booster dose is recommended 12 months after the first dose

Booster Dose

• Current data does not support the need for booster vaccination among immunocompetant subjects who have responded to a full primary vaccination course
• However, in immunocompromised subjects (e.g. subjects with chronic renal failure, haemodialysis patients, HIV positive subjects), boosters should be administered to maintain anti-HBs antibody concentrations equal or higher than the accepted protective level of 10 IU/l. For these immunocompromised subjects, post-vaccination testing every 6-12 months is advised
• National recommendations on booster vaccination should be considered

The vaccine stimulates specific humoral antibodies against hepatitis B virus surface antigen (anti-HBsAg).

Injection (per 1ml) 20μg

• Engerix-B (GSK) originator
• Heberbiovac HBV (Biovac)

Injection (per 0.5ml) 10μg

• Engerix-B Paediatric (GSK) originator
• Euvax B (Specpharm)
• Heberbiovac HBV (Biovac)