Response to Primary and Booster Vaccination With 10-valent Pneumococcal Nontypeable Haemophilus influenzae Protein D Conjugate Vaccine in Korean Infants
- Authors
- Kim, Chang-Hwi; Kim, Jung Soo; Cha, Sung-Ho; Kim, Kwang-Nam; Kim, Jong-Duck; Lee, Kyung Yil; Kim, Hwang Min; Kim, Jong-Hyun; Ma, Sang Hyuk; Hong, Jung-Yun; Park, Su Eun; Kim, Yun-Kyung; Kim, Nam Hee; Fanic, Aurelie; Borys, Dorota; Ruiz-Guinazu, Javier; Moreira, Marta; Schuerman, Lode; Kim, Kyung-Hyo
- Issue Date
- 12월-2011
- Publisher
- LIPPINCOTT WILLIAMS & WILKINS
- Keywords
- pneumococcal conjugate vaccine; immunogenicity; Streptococcus pneumoniae; Haemophilus influenzae
- Citation
- PEDIATRIC INFECTIOUS DISEASE JOURNAL, v.30, no.12, pp.E235 - E243
- Indexed
- SCIE
SCOPUS
- Journal Title
- PEDIATRIC INFECTIOUS DISEASE JOURNAL
- Volume
- 30
- Number
- 12
- Start Page
- E235
- End Page
- E243
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/111072
- DOI
- 10.1097/INF.0b013e31822a8541
- ISSN
- 0891-3668
- 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 mu g/mL after primary vaccination. Postprimary and postbooster, percentages of subjects with antibody concentration >= 0.2 mu g/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.
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