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

Chang Hwi Kim, Jung Soo Kim, Sung Ho Cha, Kwang Nam Kim, Jong Duck Kim, Kyung Yil Lee, Hwang Min Kim, Jong Hyun Kim, Sang Hyuk, Jung Yun Hong, Su Eun Park, Yun Kyung Kim, Nam Hee Kim, Aurélie Fanic, Dorota Borys, Javier Ruiz-Guiñazù, Marta Moreira, Lode Schuerman, Kyung Hyo Kim

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21 Citations (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.

Original languageEnglish
Pages (from-to)e235-e243
JournalPediatric Infectious Disease Journal
Volume30
Issue number12
DOIs
Publication statusPublished - 2011 Dec 1

Keywords

  • Haemophilus influenzae
  • Streptococcus pneumoniae
  • immunogenicity
  • pneumococcal conjugate vaccine

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Microbiology (medical)
  • Infectious Diseases

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    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-Guiñazù, J., Moreira, M., Schuerman, L., & Kim, K. H. (2011). Response to primary and booster vaccination with 10-valent pneumococcal nontypeable haemophilus influenzae protein D conjugate vaccine in Korean infants. Pediatric Infectious Disease Journal, 30(12), e235-e243. https://doi.org/10.1097/INF.0b013e31822a8541