Browse

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
dc.contributor.authorKim, Namhee-
dc.contributor.authorChoi, Gyoungjin-
dc.contributor.authorLim, Chi-Yeon-
dc.contributor.authorLee, Jae-Won-
dc.contributor.authorLee, Hoan Jong-
dc.contributor.authorKim, Kyung-Hyo-
dc.date.accessioned2012-06-12T02:15:43Z-
dc.date.available2012-06-12T02:15:43Z-
dc.date.issued2010-06-
dc.identifier.citationARCHIVES OF PHARMACAL RESEARCH; Vol.33 6; 919-924ko_KR
dc.identifier.issn0253-6269-
dc.identifier.urihttps://hdl.handle.net/10371/76975-
dc.description.abstractTo 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.isoenko_KR
dc.publisherPHARMACEUTICAL SOC KOREAko_KR
dc.subjectHaemophilus influenzae type bko_KR
dc.subjectClinical trialko_KR
dc.subjectPhase Iko_KR
dc.subjectImmunogenicityko_KR
dc.subjectConjugate vaccineko_KR
dc.subjectSafetyko_KR
dc.titleAn 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 Volunteersko_KR
dc.typeArticleko_KR
dc.contributor.AlternativeAuthor김남희-
dc.contributor.AlternativeAuthor최경진-
dc.contributor.AlternativeAuthor임치연-
dc.contributor.AlternativeAuthor이재원-
dc.contributor.AlternativeAuthor김경호-
dc.contributor.AlternativeAuthor이환종-
dc.identifier.doi10.1007/s12272-010-0615-5-
dc.citation.journaltitleARCHIVES OF PHARMACAL RESEARCH-
dc.description.citedreferenceKim KH, 2008, J KOREAN MED SCI, V23, P929, DOI 10.3346/jkms.2008.23.6.929-
dc.description.citedreferenceKIM KH, 2007, KOREAN J PEDIAT, V50, P143-
dc.description.citedreferenceTorano G, 2006, CLIN VACCINE IMMUNOL, V13, P1052, DOI 10.1128/CVI.00144-06-
dc.description.citedreferenceLottenbach KR, 2004, J AM GERIATR SOC, V52, P1883-
dc.description.citedreferenceJUNG EH, 2003, KOREAN J PEDIAT INFE, V10, P71-
dc.description.citedreferenceYANG PS, 2002, J KOREAN PEDIAT SOC, V45, P987-
dc.description.citedreferenceSantosham M, 2001, PEDIATR INFECT DIS J, V20, P931-
dc.description.citedreferenceLEE HJ, 1999, KOREAN J PEDIAT INFE, V6, P53-
dc.description.citedreferenceKIM JS, 1996, KOREAN J INFECT DIS, V28, P225-
dc.description.citedreferenceELLIS RW, 1994, DEV CLIN USES HAEMOP, P19-
dc.description.citedreferenceWENGER JD, 1992, J INFECT DIS, V165, pS34-
dc.description.citedreferenceCOULEHAN JL, 1984, PUBLIC HEALTH REP, V99, P404-
dc.description.citedreferenceLOSONSKY GA, 1984, PEDIATR INFECT DIS J, V3, P539-
dc.description.citedreferenceKAYHTY H, 1983, J INFECT DIS, V147, P1100-
dc.description.citedreferenceWARD JI, 1981, LANCET, V1, P1281-
dc.description.tc2-
Appears in Collections:
College of Medicine/School of Medicine (의과대학/대학원)Pediatrics (소아과학전공)Journal Papers (저널논문_소아과학전공)
Files in This Item:
There are no files associated with this item.
  • mendeley

Items in S-Space are protected by copyright, with all rights reserved, unless otherwise indicated.

Browse