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

Authors
 Dong Soo Kim  ;  Seon Hee Shin  ;  Hoan Jong Lee  ;  Young Jin Hong  ;  Soo Young Lee  ;  Kyong Min Choi  ;  Chi Eun Oh  ;  Ki Hwan Kim  ;  Christine Juergens  ;  Scott Patterson  ;  Peter C. Giardina  ;  William C. Gruber  ;  Emilio A. Emini  ;  Daniel A. Scott 
Citation
 PEDIATRIC INFECTIOUS DISEASE JOURNAL, Vol.32(3) : 266-273, 2013 
Journal Title
 PEDIATRIC INFECTIOUS DISEASE JOURNAL 
ISSN
 0891-3668 
Issue Date
2013
MeSH
Antibodies, Bacterial/blood ; Asian Continental Ancestry Group ; Double-Blind Method ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Drug-Related Side Effects and Adverse Reactions/pathology ; Enzyme-Linked Immunosorbent Assay ; Female ; Heptavalent Pneumococcal Conjugate Vaccine ; Humans ; Immunoglobulin G/blood ; Infant ; Infant, Newborn ; Korea ; Male ; Opsonin Proteins/blood ; Phagocytosis ; Pneumococcal Infections/immunology ; Pneumococcal Infections/prevention & control* ; Pneumococcal Vaccines/administration & dosage ; Pneumococcal Vaccines/adverse effects* ; Pneumococcal Vaccines/immunology*
Keywords
13-valent pneumococcal conjugate vaccine ; Korea ; immunogenicity ; safety ; pediatric
Abstract
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.
Full Text
http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&AN=00006454-201303000-00017&LSLINK=80&D=ovft
DOI
10.1097/INF.0b013e3182748bb6
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아청소년과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Ki Hwan(김기환)
Kim, Dong Soo(김동수)
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/87233
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