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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
DC Field | Value | Language |
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dc.contributor.author | Kim, Namhee | - |
dc.contributor.author | Choi, Gyoungjin | - |
dc.contributor.author | Lim, Chi-Yeon | - |
dc.contributor.author | Lee, Jae-Won | - |
dc.contributor.author | Lee, Hoan Jong | - |
dc.contributor.author | Kim, Kyung-Hyo | - |
dc.date.accessioned | 2012-06-12T02:15:43Z | - |
dc.date.available | 2012-06-12T02:15:43Z | - |
dc.date.issued | 2010-06 | - |
dc.identifier.citation | ARCHIVES OF PHARMACAL RESEARCH; Vol.33 6; 919-924 | ko_KR |
dc.identifier.issn | 0253-6269 | - |
dc.identifier.uri | https://hdl.handle.net/10371/76975 | - |
dc.description.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 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. | ko_KR |
dc.language.iso | en | ko_KR |
dc.publisher | PHARMACEUTICAL SOC KOREA | ko_KR |
dc.subject | Haemophilus influenzae type b | ko_KR |
dc.subject | Clinical trial | ko_KR |
dc.subject | Phase I | ko_KR |
dc.subject | Immunogenicity | ko_KR |
dc.subject | Conjugate vaccine | ko_KR |
dc.subject | Safety | ko_KR |
dc.title | 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 | ko_KR |
dc.type | Article | ko_KR |
dc.contributor.AlternativeAuthor | 김남희 | - |
dc.contributor.AlternativeAuthor | 최경진 | - |
dc.contributor.AlternativeAuthor | 임치연 | - |
dc.contributor.AlternativeAuthor | 이재원 | - |
dc.contributor.AlternativeAuthor | 김경호 | - |
dc.contributor.AlternativeAuthor | 이환종 | - |
dc.identifier.doi | 10.1007/s12272-010-0615-5 | - |
dc.citation.journaltitle | ARCHIVES OF PHARMACAL RESEARCH | - |
dc.description.citedreference | Kim KH, 2008, J KOREAN MED SCI, V23, P929, DOI 10.3346/jkms.2008.23.6.929 | - |
dc.description.citedreference | KIM KH, 2007, KOREAN J PEDIAT, V50, P143 | - |
dc.description.citedreference | Torano G, 2006, CLIN VACCINE IMMUNOL, V13, P1052, DOI 10.1128/CVI.00144-06 | - |
dc.description.citedreference | Lottenbach KR, 2004, J AM GERIATR SOC, V52, P1883 | - |
dc.description.citedreference | JUNG EH, 2003, KOREAN J PEDIAT INFE, V10, P71 | - |
dc.description.citedreference | YANG PS, 2002, J KOREAN PEDIAT SOC, V45, P987 | - |
dc.description.citedreference | Santosham M, 2001, PEDIATR INFECT DIS J, V20, P931 | - |
dc.description.citedreference | LEE HJ, 1999, KOREAN J PEDIAT INFE, V6, P53 | - |
dc.description.citedreference | KIM JS, 1996, KOREAN J INFECT DIS, V28, P225 | - |
dc.description.citedreference | ELLIS RW, 1994, DEV CLIN USES HAEMOP, P19 | - |
dc.description.citedreference | WENGER JD, 1992, J INFECT DIS, V165, pS34 | - |
dc.description.citedreference | COULEHAN JL, 1984, PUBLIC HEALTH REP, V99, P404 | - |
dc.description.citedreference | LOSONSKY GA, 1984, PEDIATR INFECT DIS J, V3, P539 | - |
dc.description.citedreference | KAYHTY H, 1983, J INFECT DIS, V147, P1100 | - |
dc.description.citedreference | WARD JI, 1981, LANCET, V1, P1281 | - |
dc.description.tc | 2 | - |
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