Shanvac-B vaccine: A DNA derived subunit vaccine for Hepatitis B

Shanvac-B vaccine is used to prevent Hepatitis B disease. It is a vaccine by Shantha lab. It is an 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 and contains Hepatitis B virus surface antigen. It is derived by DNA recombinant technology using culture of genetically engineered cells of Pichia pastoris yeast. 

It also contains aluminium salts and thimerosal in very small amounts.

How is the Shanvac-B vaccine available?

Shanvac-B vaccine is available as an injection liquid form.

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

It is available in single dose form.

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

How is the Shanvac-B vaccine stored?

Shanvac-B vaccine is stored at 2-8 degree Celsius. The temperature range should be maintained with the help of a 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 the Shanvac-B vaccine given?

Shanvac-B vaccine is given as an injection on the antero lateral aspect of the thigh in children with needle as an 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 haemophiliacs.

At what age the Shanvac-B vaccine is given?

Shanvac-B Vaccine 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 the 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 and 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 Shanvac-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 Shanvac-B vaccine.

GroupDoseSchedule
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 Shanvac-B vaccine

How does the Shanvac-B vaccine work?

Shanvac-B vaccine is an active form of immunization but it is an inactivated vaccine. Shanvac-B Vaccine 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 formed 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:

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

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

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

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

What are the side effects of the Shanvac-B vaccine?

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

  • Fever is a 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 at the injection site may last for 1-3 days and can be managed with paracetamol and local cold compression.
  • Diarhea and loss of appetite can occur after vaccination and can be managed by oral rehydration solution.
  • Nausea and vomiting may occur after the vaccination and it can be managed by oral syp ondansetron and oral rehydration solution.
  • Abdominal pain is usually mild and subsides on 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 an extremely rare side effect of the vaccine. Like other vaccines the vaccine should be administered at a center where necessary personnel and drugs and equipment 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 patients who had an allergic or anaphylactic reaction at the time of the previous dose of the vaccine.

What are the warnings 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 vaccines there is a rare risk of getting anaphylactic reaction and the center at which the vaccine is given should be equipped with a 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 of 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 will not prevent Hepatitis caused by viruses other than Hepatitis B disease.

What is vaccine vial monitor?

Vaccine vial monitor

Vaccine vial monitor is a temperature sensitive strip attached on vaccine. It indicates vaccine is usable or not. If inner square is darker than outer circle it indicates vaccine is not usable and is to be discarded.




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