View : 17 Download: 0

An open-label, single-arm, phase i study to evaluate the safety and immunogenicity of LBVH0101, a new Haemophilus influenzae type b tetanus toxoid conjugate vaccine, in healthy adult volunteers

Title
An open-label, single-arm, phase i study to evaluate the safety and immunogenicity of LBVH0101, a new Haemophilus influenzae type b tetanus toxoid conjugate vaccine, in healthy adult volunteers
Authors
Kim N.Choi G.Lim C.-Y.Lee J.-W.Kim K.-H.Lee H.J.
Ewha Authors
김경효
SCOPUS Author ID
김경효scopus
Issue Date
2010
Journal Title
Archives of Pharmacal Research
ISSN
0253-6269JCR Link
Citation
vol. 33, no. 6, pp. 919 - 924
Indexed
SCIE; SCOPUS; KCI WOS scopus
Abstract
To evaluate the safety and immunogenicity of a new Haemophilus influenzae type b tetanus toxoid conjugate vaccine, LBVH0101 (LG Life Sciences, Ltd.), an open-label, single-arm, phase I study was conducted in twenty healthy adults aged 19 years or older. The subjects were followed for 1 month after administration of a single dose of the vaccine and serum anti-PRP antibody was measured before and 1 month after administration. Among 20 vaccinated subjects, each 10 subjects (50%) reported at least one local and systemic adverse event within 7 days after the vaccination, respectively. Most of the local and systemic adverse events were mild in intensity and resolved within 7 days. There was no death or treatment-related serious adverse event. Geometric mean titers (GMTs) of anti-PRP antibody before and 1 month after the vaccination were 0.71 μg/mL (95% Confidence Interval [CI]: 0.32-1.58,) and 70.26 μg/mL (95% CI: 46.65-105.82), respectively, demonstrating the GMT of anti-PRP antibody at post-vaccination was approximately 98 times higher than that of pre-vaccination. Taken together, LBVH0101 appeared to be safe and well-tolerated and showed good immunogenicity in Korean healthy adults. © 2010 The Pharmaceutical Society of Korea and Springer Netherlands.
DOI
10.1007/s12272-010-0615-5
Appears in Collections:
의학전문대학원 > 의학과 > Journal papers
Files in This Item:
There are no files associated with this item.
Export
RIS (EndNote)
XLS (Excel)
XML


qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

BROWSE