Monograph: |
Diphtheria protein
It is the same as diphtheria toxoid, so see below at diphtheria toxoid for the
details.
Diphtheria Vaccines
Diphtheria Vaccine (Adsorbed) is
a preparation of diphtheria formol toxoid adsorbed on a min-
eral carrier. The formol toxoid is prepared from the toxin pro-
duced by the growth of Corynebacterium diphtheriae. The
mineral carrier may be hydrated aluminium hydroxide, alu-
minium phosphate, or calcium phosphate and the resulting
mixture is approximately isotonic with blood. The antigenic
properties are adversely affected by certain antimicrobial pre-
servatives, particularly those of the phenolic type. It contains
not less than 30 international units per dose. It should be
stored at 2Β° to 8Β°, not be allowed to freeze, and be protected
from light.
Diphtheria Toxoid (USP 23) is a sterile solution of the for-
maldehyde-treated products of growth of Corynebacterium
diphtheriae. It contains a non-phenolic preservative. It should
be stored at 2Β° to 8Β° and not be allowed to freeze.
Diphtheria Toxoid Adsorbed (LISP 23) is a sterile prepara-
tion of plain diphtheria toxoid that has been precipitated or
adsorbed by alum, aluminium hydroxide, or aluminium phos-
phate adjuvants. It should be stored at 2Β° to 8Β° and not be
allowed to freeze.
Units
0.5 mL of the injection of absorbed diphtheria vac-
cine available in the UK for use in children is equiv-
alent lo 30 international units; 0.5 mL of the diluted
vaccine for use in adults and older children is equiv-
alent to 2 international units. The toxoid content is
represented by flocculation equivalents or Limes
flocculationis (Lf). There is no simple correlation
between international units and Lf equivalents.
Adverse Effects and Precautions
As for vaccines in general.
Local reactions may occur but are generally not se-
vere in young children; the frequency and severity of
reactions is reported to be less in children under 2
years of age than in older children and adults.
If diphtheria vaccines or vaccines containing a diph-
theria component need to be given to children over
the age of 10 years or to adults, vaccines with a re-
duced content of diphtheria toxoid and intended for
adults and adolescents should be used. For farther
details see under Uses and Administration, below.
Uses and Administration
Diphtheria vaccines are used for active immunisa-
tion against diphtheria. The non-adsorbed vaccine
has poor immunogenic properties and its effects are
enhanced by administration as an adsorbed prepara-
tion. For primary immunisation combined diphthe-
ria, tetanus, and pertussis vaccines or
combined diphtheria and tetanus vaccines
are usually used.
A single-component diphtheria vaccine may some-
times be used for example in the event of contact
with an infected patient or a carrier. In the UK a
single-component adsorbed vaccine suitable for
infants and children and one containing a low dose
of toxoid suitable for children over 10 years of age
and adults are available and are given by deep sub-
cutaneous or by intramuscular injection in usual
doses of 0.5 mL, For primary immunisation three
doses are given at intervals of one month. For chil-
dren who receive primary immunisation during in-
fancy reinforcing doses should be given at school
entry (preferably at least 3 years after primary im-
munisation) and again on leaving school, using the
low-dose preparation.
Individuals coming into contact with a case of diph-
theria or carriers of a toxigenic strain, or those trav-
elling to an endemic or enidemic area should receive
a complete primary course or a reinforcing dose ac-
cording to their immunisation history: those not
previously immunised should receive a 3-dose pri-
mary course using the appropriate vaccine as out-
lined above, those previously immunised should
receive a single 0.5 mL dose. Unimmunised con-
tacts of a case of diphtheria should in addition
receive; a prophylactic course of a suitable antibacte-
rial. Individuals at repeated risk of expo-
sure to infection may be offered booster doses every
10 years.
If the low-dose vaccine for adults is not available, it
has been suggested that 0.1 mL of the standard
paediatric vaccine may be given as an alternative for
both primary and reinforcing doses.
Schick testing to ascertain immune status
is no longer considered necessary before adminis-
tering diphtheria vaccine to adults provided that a
low dose is given: antibody testing is used to check
immunity in those regularly exposed to diphtheria.
In some countries, booster doses of diphtheria in
combination with tetanus vaccine are recommended
every 10 years .
Conjugation to diphtheria toxoid has been used to
increase the immunogenicity of other vaccines.
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