title: Immunogenicity and safety of two different Haemophilus influenzae type b conjugate vaccines in Korean infants.
abstract: The incidence of invasive diseases, including meningitis caused by Haemophilus influenzae type b (Hib) was markedly decreased after routine immunization of Hib vaccine through diverse schedules in many countries. The purpose of this study was to evaluate the immunogenicity and safety of Hib conjugate vaccines in Korean children before the implementation of a national immunization program against Hib in Korea. A multicenter controlled trial was performed on two different Hib vaccines in Korean children. A total of 319 infants were enrolled: 199 infants were immunized with the Hib polysaccharide conjugated to the tetanus toxoid (PRP-T) and 120 infants with the Hib polysaccharide conjugated to the outer-membrane protein of Neisseria meningitides (PRP-OMP). Immunogenicity was evaluated by enzyme-linked immunosorbent assay (ELISA) and serum bactericidal assay. Both vaccines showed good immunologic responses after primary immunization. After 2 doses of PRP-T or PRP-OMP, 78.9% and 91.7% of infants achieved an antibody level of >or=1.0 microg/mL, respectively. Both vaccines were safe and well-tolerated. No serious adverse events were observed. Thus, Hib conjugate vaccines appear to be safe and show good immunogenicity in Korean infants. These results will be important reference data for the implementation of Hib vaccine in the national immunization program of Korea.
authors.affiliation: Department of Pediatrics, Ewha Womans University School of Medicine, Seoul, Korea. kaykim@ewha.ac.kr
authors.forename: Kyung Hyo
authors.initials: KH
authors.lastname: Kim
authors.forename: Hyunju
authors.initials: H
authors.lastname: Lee
authors.forename: Eun Hee
authors.initials: EH
authors.lastname: Chung
authors.forename: Jin Han
authors.initials: JH
authors.lastname: Kang
authors.forename: Jong Hyun
authors.initials: JH
authors.lastname: Kim
authors.forename: Jung Soo
authors.initials: JS
authors.lastname: Kim
authors.forename: Hoan Jong
authors.initials: HJ
authors.lastname: Lee
authors.forename: Sung Hee
authors.initials: SH
authors.lastname: Oh
authors.forename: Eun Ae
authors.initials: EA
authors.lastname: Park
authors.forename: Su-Eun
authors.initials: SE
authors.lastname: Park
mesh_terms: D001425:Bacterial Outer Membrane Proteins / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D004797:Enzyme-Linked Immunosorbent Assay; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D019741:Haemophilus influenzae type b / Q000276:immunology*; D006801:Humans; D007223:Infant; D007723:Korea; D011135:Polysaccharides, Bacterial / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D013745:Tetanus Toxoid / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*
chemical_list: D001425:Bacterial Outer Membrane Proteins; D018073:Haemophilus Vaccines; C055753:Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate; C061964:Haemophilus influenzae-type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine; D011135:Polysaccharides, Bacterial; D013745:Tetanus Toxoid