Browse

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

Cited 2 time in Web of Science Cited 2 time in Scopus
Authors
Kim, Namhee; Choi, Gyoungjin; Lim, Chi-Yeon; Lee, Jae-Won; Lee, Hoan Jong; Kim, Kyung-Hyo
Issue Date
2010-06
Publisher
PHARMACEUTICAL SOC KOREA
Citation
ARCHIVES OF PHARMACAL RESEARCH; Vol.33 6; 919-924
Keywords
Haemophilus influenzae type bClinical trialPhase IImmunogenicityConjugate vaccineSafety
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 mu g/mL (95% Confidence Interval [CI]: 0.32-1.58) and 70.26 mu g/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.
ISSN
0253-6269
Language
English
URI
http://hdl.handle.net/10371/76975
DOI
https://doi.org/10.1007/s12272-010-0615-5
Files in This Item:
There are no files associated with this item.
Appears in Collections:
College of Medicine/School of Medicine (의과대학/대학원)Pediatrics (소아과학전공)Journal Papers (저널논문_소아과학전공)
  • mendeley

Items in S-Space are protected by copyright, with all rights reserved, unless otherwise indicated.

Browse