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

作者：Kim Namhee; Choi Gyoungjin; Lim Chi Yeon; Lee Jae Won; Kim Kyung Hyo; Lee Hoan Jong^*

来源：Archives of Pharmacal Research, 2010, 33(6): 919-924.

DOI：10.1007/s12272-010-0615-5

• Haemophilus influenzae type b
• Conjugate vaccine
• Safety
• Immunogenicity
• Clinical trial
• Phase I

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.

• 出版日期2010-6