Full metadata record
DC Field | Value | Language |
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dc.contributor.author | 박은애 | * |
dc.contributor.author | 김경효 | * |
dc.date.accessioned | 2016-08-28T12:08:05Z | - |
dc.date.available | 2016-08-28T12:08:05Z | - |
dc.date.issued | 2012 | * |
dc.identifier.issn | 0264-410X | * |
dc.identifier.other | OAK-8582 | * |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/222467 | - |
dc.description.abstract | Background: The World Health Organization (WHO) recommends that all countries adopt Haemophilus influenzae type b (Hib) vaccine into routine child immunization programs to protect children from the significant burden of life-threatening pneumonia and meningitis. Methods: In this blind, comparative, randomized, phase-III Korean multicenter study, we assessed immunogenicity and safety following primary vaccination of a new H. influenzae type b tetanus toxoid conjugate vaccine, LBVH0101 (LG Life Sciences, Ltd., Seoul, Korea) compared with Hiberix™ (GSK, Rixensart, Belgium) in Korean children at 2, 4 and 6 months of age followed by a booster vaccination at 12-15 months. Serum anti-PRP IgG concentration and bactericidal activity were determined. Local/systemic symptoms were assessed after vaccination. Serious adverse events were recorded throughout the study. Results: A total of 185 infants were included in immunogenicity evaluations. After the second and third doses of LBVH0101, 90.32% and 100% of infants achieved an antibody level ≥1 μg/mL, respectively, compared with 78.26% and 96.74% of those who received Hiberix™. After the second vaccination, the geometric mean concentration (GMC) of LBVH0101 recipients was 7.34 μg/mL and was higher than that of Hiberix™ recipients (3.55 μg/mL). After the third vaccination, the GMCs were 14.59 μg/mL and 12.15 μg/mL in the LBVH0101 and Hiberix™ recipients, respectively. The booster dose produced higher antibody concentrations: 30.25 μg/mL and 71.64 μg/mL for LBVH0101 and Hiberix™ recipients, respectively. Bactericidal capacity and antibody potency of anti-PRP IgG induced by LBVH0101 was 35.05 and 116.27 after the second and third vaccinations, respectively, compared with 53.76 and 79.64 for Hiberix™. Anti-PRP IgG seroprotection rate and GMC were similar post-primary immunization between the groups; both showed functional maturation and similar booster responses. LBVH0101 had comparable safety results as the control vaccine, Hiberix™, as most of the solicited adverse events and unsolicited adverse events upon LBVH0101 administration were mild in severity. No serious vaccination-related adverse reactions were observed. Conclusions: LBVH0101 showed a good immunogenicity and safety profile in infants and children. The two-dose infant-priming schedule with a booster dose may suffice for Hib immunization in Korean infants (Clinical trial registration numbers: NCT01019772 and NCT01251133). © 2012 Elsevier Ltd. | * |
dc.language | English | * |
dc.title | Immunogenicity and safety of LBVH0101, a new Haemophilus influenzae type b tetanus toxoid conjugate vaccine, compared with Hiberix™ in Korean infants and children: A randomized trial | * |
dc.type | Article | * |
dc.relation.issue | 10 | * |
dc.relation.volume | 30 | * |
dc.relation.index | SCI | * |
dc.relation.index | SCIE | * |
dc.relation.index | SCOPUS | * |
dc.relation.startpage | 1886 | * |
dc.relation.lastpage | 1894 | * |
dc.relation.journaltitle | Vaccine | * |
dc.identifier.doi | 10.1016/j.vaccine.2011.12.122 | * |
dc.identifier.wosid | WOS:000301693400017 | * |
dc.identifier.scopusid | 2-s2.0-84862826819 | * |
dc.author.google | Kim K.-H. | * |
dc.author.google | Kim Y.-K. | * |
dc.author.google | Kim N.H. | * |
dc.author.google | Chang S.H. | * |
dc.author.google | Lee J. | * |
dc.author.google | Park E.A. | * |
dc.author.google | Park S.E. | * |
dc.author.google | Eun B.W. | * |
dc.author.google | Lee H. | * |
dc.author.google | Lee H.J. | * |
dc.contributor.scopusid | 박은애(14424551500) | * |
dc.contributor.scopusid | 김경효(35448653000) | * |
dc.date.modifydate | 20240301081003 | * |