Engerix-B: Recombinant HBsAg Hepatitis B Vaccine

Engerix-B vaccine is used to prevent the Hepatitis B disease. It is vaccine by GSK vaccines Pvt Ltd. It is inactivated Hepatitis B vaccine.

This vaccine is available in adult and pediatric dosages. Pediatric dosage 0.5 ml contains Hepatitis B virus surface antigen HBsAg. Adult dose is 1 ml contains Hepatitis B virus surface antigen. 

How is Engerix-B vaccine available?

Engerix-B vaccine is available as injection liquid form.

It is available as 0.5 ml dose or 1 ml dose. It is available as pre filled syringe without needle.

It is available in single dose form.

This vaccine is packed in opaque box to protect from sunlight.

How is Engerix-B vaccine stored?

Engerix-B vaccine is stored at 2-8 degree Celsius. The temperature range should be maintained with the help of cold chain.

The temperature range should be maintained at all levels of transport and storage. The vaccine should not be frozen.

If the vaccine is frozen accidentally it should be discarded and not used for the injection.

How is Engerix-B vaccine given?

Engerix-B vaccine is given as injection on the antero lateral aspect of thigh in children with needle as intramuscular route. All the safe injection precautions should be followed while giving injection. The disposables should be discarded as per biomedical waste management protocols. The vaccine that has passed expiry should be discarded as per biomedical waste management protocol rules. For those above 19 years 1 ml dose is given. For those below 18 years 0.5 ml dose is needed.

For those who have bleeding disorder this vaccine can be administered subcutaneously and firm pressure is given after the vaccination. The vaccination should be preferably planned after getting the dose of clotting factor in haemophilliacs.

At what age Engerix-B vaccine is given?

Engerix-Bvaccine is given in routine immunization at Birth and then at 6 weeks 10 and 14 weeks of age. 

If not given in routine immunization it is given at schedule 0, then second dose at 1 month and then third dose at 6 months of first dose.

The dosing schedule is same for both infants of HBsAg positive and negative mothers.

Till age 19 dose is 0.5 ml and above that age dose for adult is 1 ml each dose.

Primary immunization for patients on hemodialysis consists of a series of 4 doses (2 mL each) given as a single 2-mL dose two 1-mL doses on a 0-, 1-, 2-, and 6-month schedule. 

In hemodialysis patients, antibody 44 response is lower than in healthy persons and protection may persist only as long as antibody levels remain above 10 mIU/mL. Therefore, the need for booster doses should be assessed by annual antibody testing. A 2-mL booster dose (as a single 2-mL dose or two 1-mL doses) should be given when antibody levels decline below 10 mIU/mL.

Whenever administration of a booster dose is appropriate, the dose of ENGERIX-B is 0.5 mL for children 10 years of age and younger and 1 mL for persons 11 years of age and older.

Persons with known or presumed exposure to the hepatitis B virus (e.g., neonates born of infected mothers HBsAg positive, persons who experienced percutaneous or permucosal exposure to the virus) should be given hepatitis B immune globulin (HBIG) in addition to Engerix-B vaccine.

Group DoseSchedule
Infants born of:
HBsAg negative mothers
HBsAg positive mothers
0.5 ml
0.5 ml
0,1,6 months
0,1,6 months
Children:
Birth through 10 years of age

0.5 ml

0,1,6 months
Adolescents:
11 through 19 years of age

0.5 ml

0,1,6 months
Adults:
20 years of age and older

1 ml

0,1,6 months
Adults on haemodialysis2 ml0,1,2,6 months
Schedule for Engerix-B vaccine

How does Engerix-B vaccine works?

Engerix-B vaccine is active form of immunization but it is inactivated vaccine. Engerix-Bvaccine contains HBs-antigen of Hepatitis B virus in inactivated form. This antigen is obtained by the recombinant technology. When this vaccine is injected to a host the immunity of the host recognizes the antigen on Hepatitis B virus. The immunity is form against this virus and in the process the memory is also formed. When the real infection occurs the immune response is boosted against the infection and protects the person against the disease itself.

Safety with other vaccine:

Engerix-B vaccine is safe with most other medicine and no drug interactions were noted. The other vaccine or other drug should not be mixed in same syringe as this vaccine.

Like other inactivated vaccines Engerix-B vaccine is considered as safe in pregnant and lactating woman, but the risk benefit ratio should be evaluated by the caregiver.

Concomitant administration of typhoid, tetanus and yellow fever vaccine is safe with Engerix-B vaccine.

Concomitant administration of Engerix-B and anti hepatitis B immunoglobulin does not alter the protective effect of Engerix-B vaccine.

What are side effects of Engerix-B vaccine?

Engerix-B vaccine causes side effect that are generally milder and can be managed at home and does not need hospital admission:

  • Fever is common side effect after the vaccination. It usually subsides in 1-3 days and can be managed very easily at home with medicine like paracetamol and sponging.
  • Swelling and pain occurs at injection site may last for 1-3 days can be managed with paracetamol and local cold compression.
  • Diarhea and loss of appetite can occur after vaccination and can be managed by oral rehydrating solution.
  • Nausea and vomiting may occur after the vaccination and it can be managed by oral syp ondansetron and oral rehydrating solution.
  • Abdominal pain is usually mild and subsides by its own.
  • Muscular pain and joint pain may be mild to moderate grade in some patients. It usually subsides in 2-3 days.
  • Headache and fatigue.
  • Anaphylaxis and allergy is extremely rare side effect of the vaccine. Like other vaccines the vaccine should be administered at center where necessary personnel and drugs and equipments are available to manage if any reaction occurs.

To whom this vaccine should not be given?

This vaccine is not given in following conditions:

  • Do not give this vaccine to a patient who is allergic to any of its components.
  • Do not give this vaccine to patient who had got allergic or anaphylactic reaction at the time of the previous dose of the vaccine.

What are warning and precautions while giving this vaccine?

Following are the precautions that are needed while giving this vaccine:

  • This vaccine is only for prevention and it will not treat the patient if already suffering from Hepatitis B disease.
  • Like all other vaccine there is rare risk of getting anaphylactic reaction and center at which vaccine is given should be equipped with facility to manage the anaphylactic shock.
  • All the safety injections precautions should be used while administering the vaccination like any other injection.
  • The vaccine which is to be disposed and also the disposable items are disposed following the local biomedical waste management protocols.
  • This vaccine may fail to induce immunity in some patients and they may need additional doses as indicated.
  • This vaccine ill not prevent Hepatitis caused by viruses other than Hepatitis B disease.


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