Immunogenicity and Safety of 13-Valent Pneumococcal Conjugate Vaccine Given to Korean Children Receiving Routine Pediatric Vaccines.
Kim, Dong Soo MD *; Shin, Seon Hee MD +; Lee, Hoan Jong MD ++; Hong, Young Jin MD [S]; Lee, Soo Young MD [P]; Choi, Kyong Min MD ||; Oh, Chi Eun MD **; Kim, Ki Hwan MD *; Juergens, Christine MD ++; Patterson, Scott PhD ++++; Giardina, Peter C. PhD [S][S]; Gruber, William C. MD [S][S]; Emini, Emilio A. PhD ++++; Scott, Daniel A. MD [S][S]
Pediatric Infectious Disease Journal.
32(3):266-273, March 2013.
(Format: HTML, PDF)
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 [micro]g/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.
(C) 2013 Lippincott Williams & Wilkins, Inc.