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Immunogenicity and Safety of 13-Valent Pneumococcal Conjugate Vaccine Given to Korean Children Receiving Routine Pediatric Vaccines

 Dong Soo Kim ; Seon Hee Shin ; Daniel A. Scott ; Emilio A. Emini ; William C. Gruber ; Peter C. Giardina ; Scott Patterson ; Christine Juergens ; Ki Hwan Kim ; Chi Eun Oh ; Kyong Min Choi ; Soo Young Lee ; Young Jin Hong ; Hoan Jong Lee 
 Pediatric Infectious Disease Journal, Vol.32(3) : 266~273, 2013 
Journal Title
 Pediatric Infectious Disease Journal 
Issue Date
BACKGROUND: The immunogenicity and safety of 13-valent and 7-valent pneumococcal conjugate vaccines (PCV13 and PCV7) were compared when administered with routine vaccines in Korea. METHODS: Healthy infants (n = 180) were randomly assigned (1:1) to receive PCV13 or PCV7 at 2, 4, 6 (infant series) and 12 months (toddler dose). Immune responses 1 month after the infant series and toddler dose were measured by enzyme-linked immunosorbent assay and opsonophagocytic activity (OPA) assay. IgG antibody geometric mean concentrations and OPA functional antibody geometric mean titers were calculated. Safety was assessed. RESULTS: After the infant series, for the 7 common serotypes, proportions of responders with IgG concentrations ≥0.35 µg/mL were comparable (≥97.6%) between groups; IgG geometric mean concentrations and OPA geometric mean titers were generally similar, but tended to be lower in the PCV13 group for some serotypes. For the 6 serotypes unique to PCV13, IgG geometric mean concentrations and OPA geometric mean titers were notably higher in the PCV13 group. Importantly, although PCV7 elicited IgG antibodies to PCV13 serotypes 5 and 19A, OPA responses were minimal, whereas serotype 6A elicited both IgG and OPA responses. These observations are consistent with at least some protection by PCV7 against 6A-mediated invasive pneumococcal disease, but no cross-protection for serotypes 5 and 19A. The toddler dose elicited higher IgG and OPA responses than postinfant series responses for most serotypes; however, for serotypes 3 and 14 only OPA responses were increased posttoddler dose. Vaccine safety profiles were similar. CONCLUSIONS: PCV13 is safe and immunogenic in Korean children. PCV13 should provide broader protection than PCV7.
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1. 연구논문 > 1. College of Medicine > Dept. of Pediatrics
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