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Recombinant
Hepatitis-B
Vaccine I.P.
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DESCRIPTION
Gene Vac-B™ (Recombinant Hepatitis - B Vaccine,
I.P.) is a non infectious recombinant DNA Hepatitis B Vaccine.
It contains purified surface antigen of the virus obtained by
culturing genetically-engineered Hansenula polymorpha yeast cells
having the surface antigen gene of the Hepatitis B virus. The
Hepatitis-B surface antigen (HBsAg) expressed in the cells of
Hansenula polymorpha is purified through several chemical steps
and formulated as a suspension of the antigen adsorbed on aluminium
hydroxide and thiomersal is added as preservative. The vaccine
does not contain any material of human or animal origin.
COMPOSITION
Each ml contains :
| 20 mcg of purified Hepatitis B
surface antigen |
| Adsorbed on Aluminium hydroxide
(Al+++) |
 1.25
mg |
| Preservative: Thiomersal |
0.01% |
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Produced in Hansenula Polymorpha
(yeast)
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| Dose : |
1 Paediatric dose - 0.5 ml |
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1 Adult dose - 1 ml |
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| By intramuscular injection |
INDICATIONS
Gene Vac-B™ is indicated for active immunisation against
Hepatitis-B infection in subjects considered at risk of exposure
to HBV-positive material.
Immunisation against hepatitis B is expected in the long term
to reduce not only the incidence of this disease, but also its
chronic complications such as chronic active hepatitis B and hepatitis
B associated cirrhosis and primary hepatocellular carcinoma.
In areas of low prevalence of hepatitis B, immunisation with Gene
Vac-B™ is recommended for neonates/infants and adolescents
as well as for subjects who are, or will be, at increased risk
of infection such as.
- Health Care Personnel.
- Patients receiving frequent
blood products.
- Personnel and residents
of institution.
- Persons at increased risk
due to their sexual behavior.
- Illicit users of addictive
injectable drugs.
- Travellers to areas with
a high endemicity of HBV.
- Infants born of mothers
who are HBV carries.
- Persons originating from
areas with a high endemicity of HBV.
- Others: Police personnel,
fire brigade personnel, armed forces personnel and anybody who through
their work or personal lifestyle may be exposed to HBV.
- Household contacts of any
of the above groups and of patients with acute or chronic HBV infection.
In areas of intermediate or high prevalence of
hepatitis B, with most of the population at risk of acquiring
the disease, immunisation should be offered to all neonates and
young children. Immunisation should also be considered for adolescents
and young adults.
The vaccine can be safely and effectively given simultaneously
but at different injection site with DTP, DT, TT, BCG, Polio vaccine
(OPV and IPV) and yellow fever vaccine.
CONTRAINDICATIONS
Gene Vac-B™
should not be administered to subjects with known hypersensitivity
to any component of the vaccine, or to subjects having shown signs
of hypersensitivity after previous Hepatitis B Vaccine administration.
PRECAUTIONS AND WARNINGS
Because of the period of latency of hepatitis-B infection
it is possible for unrecognised infection to be present at the
time of immunisation. The vaccine may not prevent hepatitis
B infection in such cases.
The vaccine will not prevent infection caused by other agents
such as hepatitis A, hepatitis C and hepatitis E and other pathogens
known to infect the liver.
The immune response to Hepatitis B vaccines is related to age.
In general, people over 40 years of age respond less well.
In haemodiaysis patients and persons with an impaired immune
system, adequate anti-HBs antibody titres may not be obtained
after the primary immunisation course and such patients may
therefore require administration of additional doses of vaccine
(see Dosage recommendation for Immunocompromised persons)
As with all injectable vaccines, appropriate medication (eg
adrenaline) should always be readily available for treatment
in case of rare anaphylactic reactions following the administration
of the vaccine.
Gene Vac-B™ should not be administered in the gluteal muscle
or intradermally since this may result in a lower immune response.
Gene Vac-B™ may be used to complete a primary immunisation
course started either with plasma-derived or with other genetically-engineered
hepatitis B vaccines, or as a booster dose in subjects who have
previously received a primary immunisation course with plasma-derived
or with other genetically-engineered hepatitis B vaccines.
ADVERSE REACTIONS
The undersirable events are temporally related to the administration
of Hepatitis B Vaccine. They are usually mild and confined to
the first few days of the vaccination. The most common reactions
are mild soreness, erythema, induration, fatigue, fever, malaise,
influenza-like symptoms
Less common systemic reactions include nausea, vomiting, diarrhoea,
abdominal pain, abnormal liverfunction tests, arthralgia, mystalgia,
rash, pruritus, urticaria, liver function.
DOSAGE AND ADMINISTRATION
Paediatric dose vaccines 10 mcg dose (in 0.5 ml suspension) is recommended for neonates, infants and children upto 10 years of age.
Adult dose vaccine 20 mcg dose (1.0 ml suspension) is recommended
for adults and children above 10 years of age.
IMMUNISATION SCHEDULE
Primary Immunisation A series of three intramuscular injections
is required to achieve optimal protection.
Two primary immunisation schedules can be recommended:
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A rapid schedule, with immunisation
at 0,1 and 2 months, will confer protection more quickly and
is expected to provide better patient compliance.
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Schedules which have more time
between the second and third doses. such as immunisation
at 0,1 and 6 months, may take longer to confer protection,
but will produce higher anti-HBs antibody
titres.
The immunisation schedule may be
adapted to meet local immunisation recommendations.
The following timing of injections gives general guidance :
| 1st dose |
at elected date |
| 2nd dose |
4 to 10 weeks after the 1st dose |
| 3rd dose |
1 to 5 months after the 2nd dose |
BOOSTER DOSE.
It would seem advisable to recommend a booster dose when the anti-HBs
antibody titre falls below 10 IU/L, particularly for all people
at risk.
- After the 0, 1, 2 month primary immunisation
schedule a booster dose is recommended 12 months after the first
dose. The next booster may be required after 8 years.
- After the 0, 1, 6 month primary immunisation
schedule a booster dose may be required after 5 years
after the primary course.
SPECIAL DOSAGE RECOMMENDATIONS DOSAGE RECOMMENDATION
FOR NEONATES BORN OF MOTHERS WHO ARE HBV CARRIERS.
The 0, 1, 2 month immunisation schedule is recommended, and
should start at birth. Concommitant administration of Hepatitis
B immunoglobulin not necessary, but when Hepatitis B immunoglobulin
is given simultaneously with Gene Vac-B™ a separate injection
site must be chosen.
DOSAGE RECOMMENDATION FOR KNOWN OR PRESUMED EXPOSURE OF HBV
In circumstances where exposure to HBV has recently occurred (eg
needlesstick with contaminated needle) the first dose of Gene
Vac-B™ can be administered simultaneously with Hepatitis
B immunoglobulin which however must be given at a separate injection
site. The rapid immunisation schedule should be advised.
DOSAGE RECOMMENDATION FOR IMMUNOCOMPROMISED PERSONS.
The primary immunisation schedule for chronic haemodialysis patients
or persons who have an impaired immune system is four doses of
40 mcg at 0, 1, 2 and 6 months from the date of first dose. The
immunisation schedule should be adapted in order to ensure that
the anti-HBs antibody titre remains above the accepted protective
level of 10 IU/L
METHOD OF ADMINISTRATION
Gene Vac-B™ should be injected intramusculary in the
deltoid region in adults and children or in the anterolateral
thigh in neonates, infants and young children. The vaccine may
be administered subcutaneously in patients with thrombocytopenia
or bleeding disorders. The vaccine should be well shaken before
use. Only sterile needle and syringes should be used for each
injection.
STORAGE
Gene Vac-B™ should be stored between 2° and 8°C.
Not to be frozen. Discard if vaccine has been frozen.
PRESENTATIONS
| 0.5 ml |
Single dose (Pediatric) vial |
| 5 ml |
10 doses (Pediatric) vial |
| 1 ml |
Single dose (Adult) vial |
| 10 ml |
10 doses (Adult) vial |
