Hepatitis a single dose vaccine
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Hepatitis A vaccine containing inactivated hepatitis A virus.
In the absence of an international standardised reference, the antigen content for each brand of vaccine is expressed using the manufacturer's in-house reference standard.
Drugs List
Therapeutic Indications
Uses
Hepatitis - infective A - prophylaxis
Active immunisation against infections caused by hepatitis A virus.
The vaccine is especially indicated for individuals with an increased risk of acquiring or transmitting the infection. These include:
People travelling to, or living in, areas where hepatitis A is endemic (medium or high endemicity).
Individuals in areas where an outbreak of hepatitis A occurs.
Recent close contact of infected individuals.
Potential contact of infected individuals (e.g. childcare or healthcare workers).
Staff and residents of homes for those with severe learning difficulties.
Laboratory workers who may be exposed to the virus.
Individuals who work with primates.
Food handlers.
Military and diplomatic personnel.
Haemophiliacs treated with plasma derived clotting factors
Parenteral drug abusers.
Individuals who are at risk due to their sexual behaviour (e.g. men who have sex with men).
Sanitisation workers exposed to untreated sewage.
Patients with chronic or severe hepatic disease (including alcoholic cirrhosis, chronic hepatitis B, chronic hepatitis C, autoimmune hepatitis, primary biliary cirrhosis)
Previously unvaccinated contacts of cases of hepatitis A with onset of jaundice within the last week).
Dosage
For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed:
www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book
Adults
Primary immunisation
Single dose of a vaccine for adults given intramuscularly.
Booster dose
A booster dose is recommended 6 to 12 months after the initial dose in order to ensure long term protection (for at least 10 years). Some products may state 6 to 18 months after initial dose.
It is not necessary to use the same brand of vaccine for the primary dose and the booster dose.
There is evidence for some brands that administration of a booster dose which has been delayed for up to 3 years after the primary dose induces similar antibody levels as a booster dose administered within the recommended time interval. A booster dose given up to 5 years after initial vaccination can also show a satisfactory antibody response but approximately 30% of individuals receiving a delayed booster have no detectable anti-HAV antibodies prior to booster dosing.
It is unnecessary to restart the primary vaccination schedule if the booster is administered within 5 years of the primary vaccination.
Current recommendations do not support the need for further booster vaccination among immunocompetent patients after a 2 dose vaccination course.
The results described above should be considered to apply only to immunocompetent adults.
Children
The lower and upper age for which the vaccine is licensed may vary for different brands of vaccine. Check the manufacturer's recommendation before administration.
Primary immunisation
Single dose of paediatric vaccine given intramuscularly.
Booster dose
A booster dose is recommended 6 to 12 months after the initial dose in order to ensure long term protection (for at least 10 years). Some brands state that the booster dose is recommended 6 to 18 months following primary vaccination.
It is not necessary to use the same brand of vaccine for the primary dose and the booster dose.
There is evidence for some brands that administration of a booster dose which has been delayed for up to 3 years after the primary dose induces similar antibody levels as a booster dose administered within the recommended time interval. However, to ensure continuous protection, the booster dose should be given 6 to 12 months after primary administration.
Current recommendations do not support the need for further booster vaccination among immunocompetent patients after a 2 dose vaccination course.
Adolescents
The lower and upper age for which the vaccine is licensed may vary for different brands of vaccine. Check the manufacturer's recommendation before administration.
Primary immunisation
Single dose of vaccine appropriate for the age of the patient given intramuscularly.
Booster dose
A booster dose is recommended 6 to 12 months after the initial dose in order to ensure long term protection (for at least 10 years). Some brands state that the booster dose is recommended 6 to 18 months following primary vaccination.
It is not necessary to use the same brand of vaccine for the primary dose and the booster dose.
There is evidence for some brands that administration of a booster dose which has been delayed for up to 3 years after the primary dose induces similar antibody levels as a booster dose administered within the recommended time interval. A booster dose given up to 5 years after initial vaccination can also show a satisfactory antibody response but approximately 30% of individuals receiving a delayed booster have no detectable anti-HAV antibodies prior to booster dosing.
It is unnecessary to restart the primary vaccination schedule if the booster is administered within 5 years of the primary vaccination.
Current recommendations do not support the need for further booster vaccination among immunocompetent patients after a 2 dose vaccination course.
The results described above should be considered to apply only to immunocompetent patients.
Additional Dosage Information
If immediate protection against hepatitis A is necessary, the vaccine can be administered at the same time as immunoglobulin provided that separate injection sites are used.
As the vaccine is inactivated, association with other inactivated vaccines given at another injection site is unlikely to interfere with the immune response.
Administration
For intramuscular injection in the deltoid region.
Other routes are not suitable, but subcutaneous injection may be considered for some brands in patients with severe bleeding disorders such as thrombocytopenia, haemophilia or other patients at risk of haemorrhage following intramuscular injection. See specific product literature for details.
Contraindications
Children under 1 year
Severe febrile conditions
Precautions and Warnings
Immunosuppression
Haemodialysis
Hepatic disorder
History of jaundice
Immunodeficiency syndromes
Phenylketonuria
Pregnancy
Severe coagulopathy
Dialysed or immunocompromised patients may require further vaccinations
Postpone immunisation if there is active or suspected infection
Advise ability to drive/operate machinery may be affected by side effects
Impaired response possible in immunocompromised patients
Not all available brands are licensed for all age groups
Not all available brands are licensed for all routes of administration
Vaccine may not be effective in 100% of patients
May contain polysorbate
May contain trace amounts of neomycin
May contain trace amounts of polymyxin
Presentation (e.g. syringe, needle cap) may contain a derivative of latex
Some brands may contain formaldehyde
Some formulations contain egg phospholipids
Some products may contain phenylalanine
Do not mix with other vaccines in the same syringe
Do not use if any signs of precipitate or particulate matter apparent
Inject other vaccines at different sites
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Consider SC rather than IM inj in patients with severe bleeding disorders
May not be effective in patients incubating hepatitis
Does not cause immediate protection, antibody induction may take 2-4 weeks
Because of the long incubation period (approximately 20 to 50 days) for hepatitis A, it is possible for unrecognised hepatitis A to be present at the time the vaccines is given. The vaccine may not prevent hepatitis A in such individuals.
In the event that the booster vaccination has been delayed, there may be a decreased anti-hepatitis response.
Syncope can occur before or following vaccination, especially in adolescents as a psychogenic response to the needle injection. Ensure procedures are in place to avoid injury from faints.
Trace amounts of formaldehyde, neomycin and polymyxin are found in some brands; see specific product literature for details.
A reduced immune response is possible when administered subcutaneously.
The vaccine should not be administered into the buttocks as effectiveness of the vaccine may be reduced due to varying amounts of fatty tissue in this area.
Pregnancy and Lactation
Pregnancy
Use hepatitis A vaccine with caution in pregnancy.
There is limited published information regarding the use of hepatitis A vaccine in pregnancy, but based on similar vaccines risk is considered to be minimal.
The Green Book recommends that hepatitis A vaccine may be given in pregnancy where there is a definite risk of infection.
Schaefer (2015) state that pregnant women at risk of acquiring hepatitis are recommended to undergo a vaccination.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Hepatitis A vaccine may be used in breastfeeding.
There is limited published information regarding the use of hepatitis A vaccine in breastfeeding.
The Green Book states that there is no evidence of risk from vaccinating breastfeeding mothers when there is a definite risk of infection. Lactmed (2016) state that hepatitis A vaccine does not affect the safety of breastfeeding and should not be contraindicated during breastfeeding.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Abdominal discomfort
Abdominal distension
Abdominal pain
Abnormal faeces
Allergic reaction
Anaphylactic shock
Anaphylactoid reaction
Anaphylaxis
Angioedema
Anorexia
Arm pain
Arthralgia
Asthenia
Asthma
Ataxia
Back pain
Chest pain
Chills
Clamminess
Cold sweat
Constipation
Convulsions
Cough
Crying
Decreased appetite
Dehydration
Dermatitis
Diarrhoea
Dizziness
Drowsiness
Ear pain
Ecchymosis (injection site)
Eczema
Eructation
Erythema at injection site
Erythema multiforme
Fatigue
Fever
Flatulence
Flushing
Gait abnormality
Guillain-Barre syndrome
Haematoma
Headache
Heat and redness (injection site)
Hypersomnia
Hypoaesthesia
Increased bowel action
Increases in hepatic enzymes
Induration (injection site)
Influenza-like symptoms
Injection site reactions
Insomnia
Irritability
Lethargy
Lid margin crusting
Malaise
Myalgia
Nasal congestion
Nausea
Nervousness
Neuralgic amyotrophy
Nodules (injection site)
Oropharyngeal pain
Pain / soreness (injection site)
Paraesthesia
Pruritus
Rash
Restlessness
Rhinitis
Rhinorrhoea
Serum sickness-like reactions
Sleep disturbances
Sneezing
Somnolence
Stiffness
Sweating
Swelling (injection site)
Syncope
Synovitis
Tenderness (injection site)
Thrombocytopenia
Transverse myelitis
Upper respiratory tract infection
Urticaria
Vasculitis
Visual disturbances
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111.
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: May 2013
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Immunisation against infectious disease - The Green Book.
Available at: www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 05 July 2018.
Summary of Product Characteristics: Avaxim. Sanofi Pasteur MSD Ltd. Revised May 2018.
Summary of Product Characteristics: Havrix Junior Monodose. GlaxoSmithKline UK. Revised December 2016.
Summary of Product Characteristics: Havrix Monodose. GlaxoSmithKline UK. Revised December 2016.
Summary of Product Characteristics: Vaqta Adult. Sanofi Pasteur MSD Ltd. Revised January 2017.
Summary of Product Characteristics: Vaqta Paediatric. Sanofi Pasteur MSD Ltd. Revised January 2017.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Hepatitis A vaccine. Last revised: 2 June 2016.
Last accessed: 5 July 2018.
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