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Archives of pharmacal research : a publication of the Pharmaceutical Society of Korea v.33 no.6, 2010년, pp.919 - 924   SCIE
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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

Kim, Nam-Hee    (Department of Pediatrics, Seoul National University College of Medicine   ); Choi, Gyoung-Jin    (LG Life Sciences, Ltd., Division of Clinical Research/Regulatory Affairs   ); Lim, Chi-Yeon    (LG Life Sciences, Ltd., Division of Clinical Research/Regulatory Affairs   ); Lee, Jae-Won    (LG Life Sciences, Ltd., Division of Clinical Research/Regulatory Affairs   ); Kim, Kyung-Hyo    (Department of Pediatrics and Center for Vaccine Evaluation and Study, Ewha Womans University School of Medicine   ); Lee, Hoan-Jong    (Department of Pediatrics, Seoul National University College of Medicine  );
  • 초록

    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.


  • 주제어

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

  • 참고문헌 (15)

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