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KMID : 0043320100330060919
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Archives of Pharmacal Research
2010 Volume.33 No. 6 p.919 ~ p.924
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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
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Lee Hoan-Jong
Kim Nam-Hee
Choi Gyoung-Jin
Lim Chi-Yeon
Lee Jae-Won
Kim Kyung-Hyo
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Abstract
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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 postvaccination 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.
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KEYWORD
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Haemophilus influenzae type b, Conjugate vaccine, Safety, Immunogenicity, Clinical trial, Phase I
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