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.
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 microg/mL (95% Confidence Interval [CI]: 0.32-1.58,) and 70.26 microg/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.
authors.affiliation: Department of Pediatrics, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Namhee
authors.initials: N
authors.lastname: Kim
authors.forename: Gyoungjin
authors.initials: G
authors.lastname: Choi
authors.forename: Chi-Yeon
authors.initials: CY
authors.lastname: Lim
authors.forename: Jae-Won
authors.initials: JW
authors.lastname: Lee
authors.forename: Kyung-Hyo
authors.initials: KH
authors.lastname: Kim
authors.forename: Hoan Jong
authors.initials: HJ
authors.lastname: Lee
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D005260:Female; D018073:Haemophilus Vaccines / Q000009:adverse effects* / Q000276:immunology*; D019741:Haemophilus influenzae type b / Q000276:immunology*; D006801:Humans; D007723:Korea; D008297:Male; D011134:Polysaccharides / Q000276:immunology; D013745:Tetanus Toxoid / Q000009:adverse effects* / Q000276:immunology*; D018074:Vaccines, Conjugate / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial; D018073:Haemophilus Vaccines; C055753:Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate; D011134:Polysaccharides; D013745:Tetanus Toxoid; D018074:Vaccines, Conjugate; C008984:polyribitol phosphate