Low-dose intradermal versus intramuscular administration of recombinant hepatitis B vaccine: a comparison of immunogenicity in infants and preschool children.
Two hundred infants and two hundred preschool children were randomly assigned to receive either 10 micrograms of recombinant hepatitis B vaccine (GenHevac B) intramuscularly (i.m.) or 2 micrograms intradermally (ID) in the deltoid region at 0, 1 and 6 months. Antibody to hepatitis B surface antigen (anti-HBs) was tested eight weeks after the third vaccine dose. Standard dose i.m. and low-dose ID administration of recombinant hepatitis B vaccine produced comparable rates of anti-HBs equal to or higher than 10 mIU ml-1 in infants (98% and 94%, respectively) and preschool children (98% and 100%, respectively). Although i.m. vaccination produced higher anti-HBs concentrations than ID vaccination both in infants (geometric mean titre-GMT, 935 versus 621 mIU ml-1) and preschool children (GMT, 1393 versus 804 mIU ml-1), the differences were not statistically significant (p > 0.05). The preschool children tended to have higher anti-HBs concentrations than the infants. No clinically serious adverse effects were observed in both vaccine groups; however, induration 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 micrograms recombinant hepatitis B vaccine is safe and effective in infants and preschool children, and may be an acceptable, less expensive alternative to full-dose i.m. vaccination for mass immunization, especially in developing countries.
Department of Pediatrics, Ege University Faculty of Medicine, Izmir, Turkey.
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Egemen
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Aksit
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Kurugöl
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Erensoy
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Bilgiç
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Akilli
D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005260:Female; D006514:Hepatitis B Surface Antigens / Q000097:blood; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000276:immunology; D006801:Humans; D007223:Infant; D007271:Injections, Intradermal; D007273:Injections, Intramuscular; D008297:Male; D014614:Vaccines, Synthetic / Q000008:administration & dosage* / Q000276:immunology
D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D014614:Vaccines, Synthetic