title: Immunogenicity and safety of LBVH0101, a new Haemophilus influenzae type b tetanus toxoid conjugate vaccine, compared with Hiberix™ in Korean infants and children: a randomized trial.
abstract: BACKGROUND
  The World Health Organization (WHO) recommends that all countries adopt Haemophilus influenzae type b (Hib) vaccine into routine child immunization programs to protect children from the significant burden of life-threatening pneumonia and meningitis.
  
  
  METHODS
  In this blind, comparative, randomized, phase-III Korean multicenter study, we assessed immunogenicity and safety following primary vaccination of a new H. influenzae type b tetanus toxoid conjugate vaccine, LBVH0101 (LG Life Sciences, Ltd., Seoul, Korea) compared with Hiberix™ (GSK, Rixensart, Belgium) in Korean children at 2, 4 and 6 months of age followed by a booster vaccination at 12-15 months. Serum anti-PRP IgG concentration and bactericidal activity were determined. Local/systemic symptoms were assessed after vaccination. Serious adverse events were recorded throughout the study.
  
  
  RESULTS
  A total of 185 infants were included in immunogenicity evaluations. After the second and third doses of LBVH0101, 90.32% and 100% of infants achieved an antibody level ≥1 μg/mL, respectively, compared with 78.26% and 96.74% of those who received Hiberix™. After the second vaccination, the geometric mean concentration (GMC) of LBVH0101 recipients was 7.34 μg/mL and was higher than that of Hiberix™ recipients (3.55 μg/mL). After the third vaccination, the GMCs were 14.59 μg/mL and 12.15 μg/mL in the LBVH0101 and Hiberix™ recipients, respectively. The booster dose produced higher antibody concentrations: 30.25 μg/mL and 71.64 μg/mL for LBVH0101 and Hiberix™ recipients, respectively. Bactericidal capacity and antibody potency of anti-PRP IgG induced by LBVH0101 was 35.05 and 116.27 after the second and third vaccinations, respectively, compared with 53.76 and 79.64 for Hiberix™. Anti-PRP IgG seroprotection rate and GMC were similar post-primary immunization between the groups; both showed functional maturation and similar booster responses. LBVH0101 had comparable safety results as the control vaccine, Hiberix™, as most of the solicited adverse events and unsolicited adverse events upon LBVH0101 administration were mild in severity. No serious vaccination-related adverse reactions were observed.
  
  
  CONCLUSIONS
  LBVH0101 showed a good immunogenicity and safety profile in infants and children. The two-dose infant-priming schedule with a booster dose may suffice for Hib immunization in Korean infants (Clinical trial registration numbers: NCT01019772 and NCT01251133).
authors.affiliation: Department of Pediatrics and Center for Vaccine Evaluation and Study, Medical Research Institute, Ewha Womans University School of Medicine, Seoul, Republic of Korea.
authors.forename: Kyung-Hyo
authors.initials: KH
authors.lastname: Kim
authors.forename: Yun-Kyung
authors.initials: YK
authors.lastname: Kim
authors.forename: Nam Hee
authors.initials: NH
authors.lastname: Kim
authors.forename: Sung Hee
authors.initials: SH
authors.lastname: Chang
authors.forename: Jina
authors.initials: J
authors.lastname: Lee
authors.forename: Eun Ae
authors.initials: EA
authors.lastname: Park
authors.forename: Su Eun
authors.initials: SE
authors.lastname: Park
authors.forename: Byung Wook
authors.initials: BW
authors.lastname: Eun
authors.forename: Hyunju
authors.initials: H
authors.lastname: Lee
authors.forename: Hoan Jong
authors.initials: HJ
authors.lastname: Lee
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D016667:Bacterial Capsules / Q000008:administration & dosage / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D006192:Haemophilus Infections / Q000517:prevention & control; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000276:immunology*; D006801:Humans; D007117:Immunization, Secondary; D007074:Immunoglobulin G / Q000097:blood; D007223:Infant; D008297:Male; D056910:Republic of Korea; D058248:Serum Bactericidal Antibody Assay; D016037:Single-Blind Method; D013745:Tetanus Toxoid / Q000008:administration & dosage* / Q000276:immunology; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D007074:Immunoglobulin G; D013745:Tetanus Toxoid; D018074:Vaccines, Conjugate; C514867:Hiberix