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서지반출
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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  • 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
  • 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
저자명
Kim. Nam-Hee,Choi. Gyoung-Jin,Lim. Chi-Yeon,Lee. Jae-Won,Kim. Kyung-Hyo,Lee. Hoan-Jong
간행물명
Archives of pharmacal research : a publication of the Pharmaceutical Society of Korea
권/호정보
2010년|33권 6호|pp.919-924 (6 pages)
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대한약학회
파일정보
정기간행물|ENG|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

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 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.