Vaccines, Sera and Other Immunological Agents

Varicella vaccine is a lyophilized
preparation of the Oka strain of live
attenuated varicella virus obtained by
propagation of the virus in MRC5 human
diploid cell culture.
Varicella vaccine produces an attenuated clinically inapparent varicella infection in susceptible subjects.
Adverse effects include mild and
transient reaction at the site of injection,
headache, fever, paraesthesia and fatigue.
It is indicated for active immunisation
against varicella in healthy subjects from
the age of 12 months onwards. Susceptible
healthy close contacts (parents and siblings
of high-risk patients, medical, paramedical
personnel and other people who are in close
contact with varicella patients) should be
immunised in order to reduce the risk of
transmission of virus to high-risk patients.
FLU VACCINE (HIBERIX)
Influenza vaccine contains antigens
from two or three of the currently
circulating types of flu virus.
Vaccination is recommended for elderly
people particularly those with heart, lung
or kidney disease. Flu vaccination has to
be repeated before each winter because of
the possible changes in virus types.
MENINGOCOCCAL VACCINE
(MENCEVAX A & C)

This vaccine is recommended for both
adults and children to protect them from
Meningococcal meningitis.
A single dose of vaccine provides good
protection against infection caused by
meningococci. Regular revaccinations are
required for long-term protection.

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Adverse effects include low grade
fever and pain at injection site.
It is indicated for prophylaxis against
cerebrospinal meningitis due to meningococci A & C groups by SC or IM route in
single 0.5 ml dose.
PNEUMOCOCCAL VACCINE
(PNEUMO 23)
This vaccine is recommended for those
who are at risk of pneumococcal
pneumonia. A single dose of vaccine gives
protection against infection. Revaccination
is required at a later date.
It is prepared from purified pneumococcal capsular antigens and includes 23
serotypes which are responsible for at least
85% of pneumococcal infections and has
greater than 90% coverage against serotypes that are penicillin resistant.
Adverse effects include hypersensitivity, redness, slight pain and induration at
the site of injection. Rarely fever may occur.
It is indicated in prevention of
pneumococcal infections, particularly

those of respiratory origin in all subjects
over the age of two years who are at risk of
serious pneumococcal infection.
RABIES VACCINE (RABIPUR)
Commonly known as treatment for dog
bite. Rabies is usually caused by the bite of
infected dog, monkey, cat, etc. and can lead
to hydrophobia (feeling of fear of water)
and death. A series of five injections need
to be given. Usually rabies vaccine is given
once the dog bite has already taken place.
Rabies vaccines which are used for active immunisation against rabies may be


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used as part of postexposure treatment. It
may also be used as preexposure prophylaxis against rabies in high risk persons like
dog handlers etc.
Rabies vaccines may be
i. Purified chick embryo cell rabies
vaccine.
ii. Inactivated rabies vaccine prepared on
vero cells. This vaccine for the pre or
postexposure immunization against
rabies is obtained by culture on vero
continuous cell lines.
iii. Human diploid cell rabies vaccine.
iv. Highly purified duck embryo rabies
vaccine.

Adverse effects include pain,
reddening and swelling at injection site,
swollen lymph nodes, joint pains and GI
complaints.
It is indicated for immunization
against rabies after exposure and for
prophylactic vaccination against rabies
before exposure.
Dosage: Vaccine should be given
intramuscular in the deltoid region only.
a. Preexposure: 3 dose IM injections on
day 0, 7 and 28. A booster dose after
one year and one dose after every five
years. In case of subsequent exposure,
only two doses at day 0 and day 3
provide protection, if proper previous
vaccination status is available.
b. Postexposure: After exposure start
immediately a full course of treatment
for both adults and children consists
of 5 injections on days 0 (day of
exposure), 3, 7, 14 and 30. A booster
dose on day 90 is optional.

Section 13/ Miscellaneous

MEASLES VACCINE
It contains live attenuated EdmonstonZagreb strain of measles virus propagated
on human diploid cells.
Adverse effects include fever which

may be accompanied by skin rash, malaise,
cough, headache and rarely febrile
convulsions.
It is indicated for active immunization
of children and susceptible adults by SC
route in a dose of 0.5 ml.
TETANUS TOXOID
It is a sterile uniform suspension of
tetanus toxoid adsorbed on aluminium
phosphate and suspended in isotonic saline
used for active immunization against
tetanus.
Adverse effects include mild local
reactions, tenderness and induration at the
site of injection.
Dosage:
For active primary immunization: Two
doses of 0.5 ml each by IM route at an
interval of four to six weeks. Reinforcing
dose should be given, six to eight months
later, to increase the level of immunity.
Booster dose: In previously immunized
persons, a booster dose of 0.5 ml IM should
be given every five years to maintain
adequate level of immunity. The need for
tetanus vaccine in wound management
depends both on the condition of the
wound and immunisation history of the
patient. For tetanus prone wound, tetanus
immunoglobulin may also be required.



Vaccines, Sera and Other Immunological Agents

RUBELLA VACCINE (R-VAC)
It is used for active immunisation
against rubella. It is administered to girls
aged 10 to 14 years. It is also recommended
for women of child bearing age if they are
seronegative, women who are found to
seronegative during pregnancy should be
vaccinated in the early postpartum period.
Pregnancy should be avoided for at least
one month after vaccination.
ANTISNAKE VENOM
The venom of snake is a complex mixture
of protein which has enzymatic activity and
may also provoke local inflammatory
reaction. The venom may have effect on
tissue, blood vessels, blood cell coagulation
or neurotoxic effect with sensory, motor and
respiratory involvement. Management of
snake bite involves general supportive care
and monitoring of vital functions but in a
systemic snake bite poisoning, specific
antivenom is the most effective therapy. It
is highly recommended to wait for clear
clinical evidence of systemic poisoning
before giving antivenom. Monospecific
antivenoms are more effective and are less

likely to cause side effects than polyvalent
antivenoms.
IMMUNOGLOBULINS
These are preparations containing
antibodies
against
infectious
microorganisms and are usually prepared
from human plasma or serum.
Normal immunoglobulins are prepared
from material from blood donors and
contain several antibodies against
infectious diseases prevalent in the general

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population. Specific immunoglobulins
contain minimum specified levels of one
antibody.
Anti-D immunoglobulins are given to
prevent the formation of rhesus antibodies
in rhesus-negative (Rh –ve) persons on
exposure to rhesus positive red blood cells.
TETANUS IMMUNOGLOBULIN (TIG;
TETGLOB)
It is a sterile solution of hyperimmunoglobulin prepared from the placenta of
healthy volunteers specifically immunised
against tetanus.
Adverse effects include local pain,
fever, flushing, headache and chills.

It is indicated in subjects already
sensitised with serums of animal origin,
existence of prior or present allergic
manifestations (asthma, eczema, etc.),
burns, injuries, open and compound
fractures; unimmunized or inadequately
immunised mothers.
Dosage:
Prophylaxis: 250-500 IU intramuscular.
Therapeutic: Tetanus neonatorum 500
to 10,000 IU intramuscular or 250 IU
intrathecal. In adults and children 500 to
10,000 IU intramuscular and/or 250 to 500
IU intrathecally.
RABIES IMMUNOGLOBULIN
(BERIRAB-P)
It provides passive protection when
given immediately to individuals exposed
to rabies virus. This provides maximum
circulating antibody with minimum


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interference of active immunisation with
human diploid cell vaccine.
Adverse effects include local
tenderness, muscle soreness or stiffness at
the injection site, low grade fever,
sensitisation to repeated injections of

human globulin in immunoglobulin
deficient patients.
It is indicated in all injuries, even licks,
on mucous membranes by wild animals (or
even pet animals) suspected to be suffering
from rabies.
HEPATITIS B IMMUNOGLOBULIN
(HEPABIG)
HBIG provides immediate passive
immunity for those individuals with acute
exposure to HBsAg positive blood/blood
derivatives. Clinical trials have
demonstrated reduction in attack rate of
clinical hepatitis B following its use. After
administration of the usual recommended
dose of the HBIG there is a detectable level
of circulating anti-HBsAg antibody which
persist for three months. No case of
transmission of hepatitis B has been
associated with the use of this product.
HBIG does not interfere with generation
of antibody response to hepatitis B vaccine.
Ideally, persons exposed to blood which
contains hepatitis B virus should be given
combined passive active immunization.
Adverse effects include transient, mild
pain at the site of injection and itching.
It is indicated for prophylaxis of
hepatitis B after exposure to HBsAg e.g. by
accidental ‘needle-stick’, contact by

accidental splash or oral ingestion

Section 13/ Miscellaneous

(pipetting accident) involving HBsAg
positive material such as blood, plasma or
serum.
For prophylaxis of hepatitis B in
neonates born to HBsAg positive mothers.
Dosage: Following exposure to HBsAg.
Adults: 1,000 to 2,000 IU IM.
Children: 32 to 48 IU/kg body weight
This should be administered within seven
days (preferably within 48 hrs) after
exposure to HBsAg.
Neonates: Initial dose is 100 to 200 IU. The
first dose should be administered within five
days after birth. The booster dose should
be 32 to 48 IU/kg of body wt. between two
to three months after initial dose.
HUMAN NORMAL
IMMUNOGLOBULIN (BHARGLOB)
It is indicated for prophylaxis of
infectious diseases and immunotherapy.
Adverse effects include flushing with
chills, nausea and headache.
GAMMAGLOBULIN (HISTOGLOB)
Intravenous
gamma
globulin

preparations are available for replacement
therapy for patients with congenital
agammaglobulinaemia and hypogammaglobulinaemia, idiopathic thrombocytopenic
purpura and Kawasaki syndrome. It is also
used for prophylaxis of infection following
bone marrow transplantation.
HUMAN ANTI-D
IMMUNOGLOBULIN (RHOCLONE)
It is indicated for prevention of
development of anti-D antibodies in Rh


Vaccines, Sera and Other Immunological Agents

negative mothers after child birth, abortion
beyond 13 weeks gestation, antepartum
prophylaxis at 26 to 28 weeks gestation.
Dosage:
Adults: Prophylaxis after delivery, abortion, amniocentesis: 300 mcg IM within 72
hours. Massive transplacental haemorrhage: 25 mcg/ml of foetal erythrocytes.
HISTAGLOBULIN
Histaglobulin is a lyophilised preparation of histamine (as histamine dihydrochloride) coupled with human normal
immunoglobulin.
Histaglobulin is thoroughly screened for
hepatitis B surface antigen and anti HIV
using third generation technique RIA and
ELISA and is found to be non-reactive.
As histamine by itself is not an
antigenic molecule, it is conjugated with
globular protein to form a complete antigen

wherein histamine acts as hapten when
injected into a living body, forming
antibodies to the hapten histamine
complex. Antibodies thus formed increase
the histamine binding capacity of serum.
It has been demonstrated that the histamine
binding capacity of normal plasma is 20
percent to 30 percent, whereas it is only
zero to five percent in allergic patients.
Adverse effects include nausea,
vomiting and vasodilatation in the facial
area.
It is indicated in bronchial asthma,
migraine, urticaria, eczema, allergic
rhinitis, pruritus, neurodermatitis, atopic
dermatitis and other allergic disorders.

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IMMUNOSUPPRESSANTS
These are the agents used to suppress the
immunity. The drugs like azathioprine and
cyclosporin A are used chiefly to prevent
rejection in organ transplantation. They are
also used for treatment of autoimmune
disease.
AZATHIOPRINE (IMURAN)
It is a purine antagonist, immunosuppressant drug which suppresses cell mediated immunity. It acts by inhibiting DNA
synthesis and hence prevents proliferation
of T-lymphocytes.

After administration in body it is
converted to mercaptopurine.
Adverse effects include skin rash, bone
marrow depression, GI disturbances and
hepatotoxicity.
It is indicated in renal transplantation,
severe active rheumatoid arthritis
unresponsive to other therapy, certain
autoimmune diseases, chronic active
hepatitis, idiopathic thrombocytopenic
purpura and acquired haemolytic
anaemia.
Dosage:
Renal transplantation: Initially 3 to 5 mg/
kg/day followed by 1 to 3 mg/kg/day as
maintenance dose.
Rheumatoid arthritis: Initially 1 mg/kg as
a single dose; if required increase after six to
eight weeks by 0.5 mg/kg/day at four weeks
intervals up to a maximum of 2.5 mg/kg/day.
CYCLOSPORINE A (SANDIMMUN)
It inhibits early cellular response to
antigenic and regulatory stimuli, mainly in