Hepatitis A Vaccine (Inactivated, Adsorbed)

Registered South African indications:

• Active immunisation against infection caused by hepatitis A virus

Contraindications

Registered South African contraindications

80 & 160 units/0.5ml

• History of severe allergic reaction to any component of the vaccine, or after previous administration of the vaccine or a vaccine containing the same components or constituents
• Vaccination must be postponed in case of febrile or acute disease

1440 units/ml & 720 units/0.5ml

• Known hypersensitivity to any components of the vaccine, or having shown signs of hypersensitivity after previous administration the vaccine

Contraindications registered in other jurisdictions

80 & 160 units/0.5ml

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to neomycin which may be present in the vaccine in trace amounts
• Hypersensitivity following a previous injection of this vaccine
• Vaccination should be delayed in subjects with an acute severe febrile illness

1440 units/ml & 720 units/0.5ml

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to neomycin which may be present in the vaccine in trace amounts

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Acute febrile illness
• Congenital or acquired immunodeficiency
• Haemodialysis

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

South African registered indications and dosages

160 units/0.5ml

Active immunisation against infection caused by hepatitis A virus

• IM: Primary: 0.5ml, as a single dose; Booster dose: 0.5ml, to be given between 6 to 36 months apart in order to confer long-term protection

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Current recommendations do not support the need for further booster vaccinations for immunocompetent individuals after the initial two-dose vaccination course

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The vaccine must not be mixed with other vaccines or medicinal products. As hepatitis A vaccine (inactivated) is adsorbed, the vaccine must be injected by intramuscular route in order to minimize local reactions. The recommended site of injection is the deltoid region. Shake syringe before injection to get a homogeneous suspension

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1440 units/ml

Active immunisation against infection caused by hepatitis A virus (HAV) in subjects at risk of exposure to HAV
- Travellers
- Armed forces
- Persons for whom hepatitis A is an occupational hazard or for whom there is an increased risk of transmission
- Increased risks due to sexual behaviour
- Haemophiliacs
- Abusers of injectable drugs
- Contacts of infected persons
- Persons who require protection as part of hepatitis A outbreak control or because of regionally elevated morbidity
- Specific population groups known to have a higher incidence of hepatitis A
- Subjects with chronic liver disease or risk factors thereof (e.g. hepatitis B and hepatitis C carriers and alcohol abusers)
- Areas of intermediate to high prevalence

• IM: 1ml, as a single dose; Booster to be given between 6 and 12 months in order to ensure long term antibody titres

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For intramuscular use. The recommended site of injection is the deltoid region. DO NOT administer intravenously

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

South African registered indications and dosages

80 units/0.5ml

Active immunisation against infection caused by hepatitis A virus

Younger than 12 months

• No information available

Between 12 months - 15 years

• IM: Primary: 0.5ml, as a single dose; Booster dose: 0.5ml, to be given between 6 to 36 months apart in order to confer long-term protection

16 years and older

• See adult dosage

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Data available on vaccination with the 80 units/0.5ml hepatitis A vaccine (inactivated, adsorbed) shows there is no need for further booster vaccinations for immunocompetent individuals after the initial two-dose vaccination course. In a setting transitioning from high to intermediate endemicity, it was observed that after the administration of a single dose, subjects still show satisfactory anti-HAV response up to 7 years after initial vaccination, which is consistent with WHO recommendations

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The vaccine must not be mixed with other vaccines or medicinal products. As hepatitis A vaccine (inactivated) is adsorbed, the vaccine must be injected by intramuscular route in order to minimize local reactions. The recommended sites of injection are: the quadriceps in young children and the deltoid in older children and adolescents. Shake syringe before injection to get a homogeneous suspension

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720 units/0.5ml

Active immunisation against infection caused by hepatitis A virus (HAV) in subjects at risk of exposure to HAV
- Travellers
- Armed forces
- Persons for whom hepatitis A is an occupational hazard or for whom there is an increased risk of transmission
- Increased risks due to sexual behaviour
- Haemophiliacs
- Abusers of injectable drugs
- Contacts of infected persons
- Persons who require protection as part of hepatitis A outbreak control or because of regionally elevated morbidity
- Specific population groups known to have a higher incidence of hepatitis A
- Subjects with chronic liver disease or risk factors thereof (e.g. hepatitis B and hepatitis C carriers and alcohol abusers)
- Areas of intermediate to high prevalence

Younger than 1 year

• Not established for use

Between 1- 15 years

• IM: 0.5ml, as a single dose; Booster to be given between 6 and 12 months in order to ensure long term antibody titres

Older than 16 years

• See adult dosage

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For intramuscular use. The recommended site of injection is the deltoid region for children and in the antero-lateral part of the thigh in young children. DO NOT administer intravenously

Pregnancy

South African recommendations

• Caution; not recommended
• Animal reproduction studies have not been conducted with hepatitis A vaccine (inactivated, adsorbed). Data on the use of this vaccine in pregnant women are limited. Therefore, the administration of the vaccine during pregnancy is not recommended
• Hepatitis A vaccine (inactivated, adsorbed) should be given to pregnant women only if clearly needed, and following an assessment of the risks and benefit

Recommendations in other jurisdictions

• Caution; not recommended
• There are no adequate data from the use of hepatitis A vaccine (inactivated, adsorbed) in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development. The potential risk for humans is unknown
• Hepatitis A vaccine (inactivated, adsorbed) should not be used during pregnancy unless clearly necessary and following an assessment of the risks and benefits

Breastfeeding

South African recommendations

• Caution
• It is not known whether hepatitis A vaccine (inactivated, adsorbed) is excreted in human milk. Caution must be exercised when it is administered to a nursing mother

Recommendations in other jurisdictions

• 160 units/0.5ml: Compatible
  • The use of this vaccine is possible during breastfeeding
• 1440 units/ml: Caution
  • It is unknown whether this vaccine is excreted in human milk
  • A decision must be made whether to discontinue breastfeeding or to abstain from vaccination taking into account the benefit of breastfeeding for the child and the benefit of vaccination for the woman

Fertility

Recommendations below are applicable to South Africa and other jurisdictions

• No information available

South African recommendations

• Caution; no information available

Recommendations in other jurisdictions

• No dose adjustment recommended

South African recommendations

• Caution; no information available

Recommendations in other jurisdictions

• Caution; no dose adjustment recommended

South African recommendations

• Caution; no information available

Recommendations in other jurisdictions

• No dose adjustment recommended

Central Nervous System Disorders

• Irritability
• Headache
• Drowsiness
• Dizziness
• Hypoaesthesia
• Paraesthesia
• Convulsions
• Guillain Barre syndrome
• Transverse myelitis
• Neuralgic amyotrophy

Cardiovascular Disorders

• Vasculitis

Respiratory Disorders

• Upper respiratory tract infection
• Rhinitis

Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhoea

Hepatobiliary Disorders

• Transient increase in hepatic function tests

Endocrine and Metabolic Disorders

• Loss of appetite

Musculoskeletal Disorders

• Myalgia
• Musculoskeletal stiffness
• Arthralgia

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritus
• Angioneurotic oedema
• Erythema multiforme
• Urticaria

Immune, Blood and Lymphatic System Disorders

• Anaphylaxis

• Immunoglobulin

Hepatic function

Hepatitis A vaccine (inactivated) confers immunity against hepatitis A virus by inducing antibody titres greater than those obtained after passive immunisation with immunoglobulin. Antibody appears shortly after the first injection and 14 days after vaccination more than 90% of immunocompetent subjects are seroprotected (titre above 20 mIU/millilitre).

GBM hepatitis A virus strain produced on MRC-5 human diploid cells (80 & 160 units/0.5ml)
HM175 hepatitis A virus strain produced on MRC-5 human diploid cells (720 units/0.5ml & 1440 units/ml)

Injection (per 0.5ml) 720u

• Havrix junior (GSK) originator

Injection (per ml) 1440u

• Havrix 1440 (GSK) originator