S-Space College of Medicine/School of Medicine (의과대학/대학원) Pediatrics (소아과학전공) Journal Papers (저널논문_소아과학전공)
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
- Kim, Namhee; Choi, Gyoungjin; Lim, Chi-Yeon; Lee, Jae-Won; Lee, Hoan Jong; Kim, Kyung-Hyo
- Issue Date
- PHARMACEUTICAL SOC KOREA
- ARCHIVES OF PHARMACAL RESEARCH; Vol.33 6; 919-924
- Haemophilus influenzae type b; Clinical trial; Phase I; Immunogenicity; Conjugate vaccine; Safety
- 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.
- Files in This Item: There are no files associated with this item.