LOW-DOSE INTRADERMAL VERSUS INTRAMUSCULAR ADMINISTRATION OF RECOMBINANT HEPATITIS-B VACCINE - A COMPARISON OF IMMUNOGENICITY IN INFANTS ANDPRESCHOOL-CHILDREN
A. Egemen et al., LOW-DOSE INTRADERMAL VERSUS INTRAMUSCULAR ADMINISTRATION OF RECOMBINANT HEPATITIS-B VACCINE - A COMPARISON OF IMMUNOGENICITY IN INFANTS ANDPRESCHOOL-CHILDREN, Vaccine, 16(16), 1998, pp. 1511-1515
Citations number
19
Categorie Soggetti
Veterinary Sciences",Immunology,"Medicine, Research & Experimental
Two hundred infants and two hundred preschool children were randomly a
ssigned to receive either 10 mu g of recombinant hepatitis B vaccine (
GenHevac B) intramuscular ly (IM) or 2 mu g intradermally (ID) in the
deltoid region at 0, 1 and 6 months. Antibody to hepatitis B surface a
ntigen (anti-HBs) was tested eight weeks after the third vaccine dose.
Standard dose IM and low-dose ID administration of recombinant hepati
tis B vaccine produced comparable rates df anti-HBs equal to or higher
than 20 mIU ml(-1) infants (98% and 94%, respectively) and preschool
children (98% and 100%, respectively). Although IM vaccination produce
d higher anti-HBs concentrations than ID vaccination both in infants (
geometric mean titre-GMT, 935 versus 621 mIU ml(-1)) and preschool chi
ldren (GMT 1393 versus 804 mIU ml(-1)), the differences were not stati
stically significant (p > 0.05). The preschool children tended to have
higher anti-HBs concentrations than the infants. No clinically seriou
s adverse effects were observed in both vaccine groups; however indura
tion and hyperpigmentation at the injection site were more often seen
in the study population that was vaccinated intradermally. We conclude
that intradermal administration of 2 mu g recombinant hepatitis B vac
cine is safe and effective in infants and preschool children, and may
be an acceptable, less expensive alternative to full-dose IM vaccinati
on for mass immunization, especially in developing countries. (C) 1998
Elsevier Science Ltd. All rights reserved.