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Response to primary and booster vaccination with 10-valent pneumococcal nontypeable haemophilus influenzae protein D conjugate vaccine in Korean infants

Title
Response to primary and booster vaccination with 10-valent pneumococcal nontypeable haemophilus influenzae protein D conjugate vaccine in Korean infants
Authors
Kim C.-H.Kim J.S.Cha S.-H.Kim K.-N.Kim J.-D.Lee K.Y.Kim H.M.Kim J.-H.Hyuk S.Hong J.-Y.Park S.E.Kim Y.-K.Kim N.H.Fanic A.Borys D.Ruiz-Guinazu J.Moreira M.Schuerman L.Kim K.-H.
Ewha Authors
김경효
SCOPUS Author ID
김경효scopus
Issue Date
2011
Journal Title
Pediatric Infectious Disease Journal
ISSN
0891-3668JCR Link
Citation
vol. 30, no. 12, pp. e235 - e243
Indexed
SCI; SCIE; SCOPUS WOS scopus
Abstract
Background: This randomized single-blind study in Korea evaluated noninferiority of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) versus the 7-valent pneumococcal conjugate vaccine (7vCRM) when both were coadministered with H. influenzae type b (Hib) conjugate vaccine, as opposed to coadministration with diphtheria-tetanus- acellular pertussis-based combination vaccines in previous studies. Methods: Infants received 3 primary doses at 2, 4, and 6 months and a booster dose at 12 to 18 months of PHiD-CV (N = 374) or 7vCRM (N = 129), both coadministered with Hib vaccine. Immune responses were measured 1 month postdose 3 and postbooster using 22F-inhibition enzyme-linked immunosorbent assay and functional opsonophagocytic activity assay. Results: PHiD-CV-induced antibody responses against each of the vaccine pneumococcal serotypes and protein D. Noninferiority to 7vCRM was demonstrated for all 10 PHiD-CV serotypes in terms of percentages of subjects reaching an antibody concentration 0.2 μg/mL after primary vaccination. Postprimary and postbooster, percentages of subjects with antibody concentration 0.2 μg/mL or opsonophagocytic activity titer 8 were generally consistent between groups for each pneumococcal serotype common to both vaccines. The safety and reactogenicity profiles of PHiD-CV and 7vCRM were generally comparable after both primary and booster vaccination. Conclusions: In this Korean study, 3-dose PHiD-CV priming followed by a booster dose was immunogenic for all 10 vaccine pneumococcal serotypes and protein D. Noninferiority to 7vCRM in terms of enzyme-linked immunosorbent assay threshold responses postpriming was demonstrated. The safety and reactogenicity profiles of both vaccines when coadministered with Hib vaccine were generally comparable. © 2011 by Lippincott Williams & Wilkins.
DOI
10.1097/INF.0b013e31822a8541
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의학전문대학원 > 의학과 > Journal papers
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