J Korean Med Sci.  2008 Dec;23(6):929-936. 10.3346/jkms.2008.23.6.929.

Immunogenicity and Safety of Two Different Haemophilus influenzae Type b Conjugate Vaccines in Korean Infants

• Kim KH
• Lee H
• Chung EH
• Kang JH
• Kim JH
• Kim JS
• Lee HJ
• Oh SH
• Park EA
• Park SE

• KMID: 1107512
• DOI: http://doi.org/10.3346/jkms.2008.23.6.929

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 microgram/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.

Keyword

Haemophilus; Vaccines; Immunogenicity; Safety

MeSH Terms

Bacterial Outer Membrane Proteins/administration & dosage/*adverse
Enzyme-Linked Immunosorbent Assay
Haemophilus Vaccines/administration & dosage/*adverse effects/*immunology
Haemophilus influenzae type b/*immunology
Humans
Infant
Korea
Polysaccharides, Bacterial/administration & dosage/*adverse effects/*immunology
Tetanus Toxoid/administration & dosage/*adverse effects/*immunology

Figure

• 

  Fig. 1 Comparison of anti-PRP IgG titer with SBA titers in sera after 2 doses of PRP-T vaccine (n=20 serum samples) (A), sera after 3 doses of PRP-T vaccine (n=21 serum samples) (B) and sera after 2 doses of PRP-OMP vaccine (n=21 serum samples) (C). The vertical and horizontal dotted lines represent the detection limit of anti-PRP IgG antibody assay (0.15 µg/mL) and serum bactericidal assay (2), respectively.

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