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

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.