Immunogenicity and safety of two different Haemophilus influenzae type b conjugate vaccines in Korean infants.
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.
Kim
Kyung Hyo
KH
Department of Pediatrics, Ewha Womans University School of Medicine, Seoul, Korea. kaykim@ewha.ac.kr
Lee
Hyunju
H
Chung
Eun Hee
EH
Kang
Jin Han
JH
Kim
Jong Hyun
JH
Kim
Jung Soo
JS
Lee
Hoan Jong
HJ
Oh
Sung Hee
SH
Park
Eun Ae
EA
Park
Su-Eun
SE
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*
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