title: Comparison of immunogenicity between inactivated and live attenuated hepatitis A vaccines: a single-blind, randomized, parallel-group clinical trial among children in Xinjiang Uighur Autonomous Region, China.
abstract: OBJECTIVE
  To compare immunogenicity among an inactivated hepatitis A vaccine (Healive(®)) with one-dose and two-dose regimens, and three kinds of live attenuated vaccines in children.
  
  
  METHODS
  A single-blind, randomized, parallel-group clinical trial was conducted among healthy children aged 1.5-6 y in Xinjiang Uighur Autonomous Region, China. Subjects were randomly assigned to 5 groups. Two groups were administered one-dose or two-dose inactivated vaccine and the remaining groups were immunized with one of three kinds of attenuated vaccines, respectively. Serum samples were collected at 6- and 12-mo follow-ups. Anti-HAV IgG was measured with a microparticle enzyme immunoassay.
  
  
  RESULTS
  No significant differences were observed in seroconversion rates (seroprotection rates) among the five groups at 6 or 12 mo (p>0.05). The geometric mean concentration (GMC) of anti-HAV IgG was significantly higher in the two-dose Healive(®) group than in the one-dose Healive(®) group and the attenuated vaccine groups at 12 mo (932.4 vs. 112.7, 135.8, 203.3, 212.8 mIU/ml, respectively, p<0.05). In the one-dose Healive(®) group, the GMC was significantly lower than that in the attenuated vaccine B and C groups at 6 mo (152.6 vs. 212, 204 mIU/ml, p<0.05) and at 12 mo (112.7 vs. 203.3, 212.8, p<0.05), but was similar to the attenuated vaccine A group at 12 mo (112.7 vs. 135.8 mIU/ml, p>0.05). The GMCs were significantly higher in the 1-2 y of age group than in the 3-6 y of age group for all types of vaccines except the attenuated vaccine C (p<0.05) at 12 mo.
  
  
  CONCLUSIONS
  A higher GMC of anti-HAV IgG was induced in the two-dose Healive(®) than in the one-dose and the attenuated vaccines at 12 mo. The attenuated vaccine B or C produced higher GMCs than the one-dose Healive(®) at 6-12 mo after vaccination.
authors.affiliation: Department of Microbiology and Center of Infectious Disease; School of Basic Medicine; Peking University Health Science Center; Beijing, P.R. China.
authors.forename: Xue-En
authors.initials: XE
authors.lastname: Liu
authors.forename: Fuerhati
authors.initials: F
authors.lastname: Wushouer
authors.forename: Aili
authors.initials: A
authors.lastname: Gou
authors.forename: Mahemuti
authors.initials: M
authors.lastname: Kuerban
authors.forename: Xinlan
authors.initials: X
authors.lastname: Li
authors.forename: Yubo
authors.initials: Y
authors.lastname: Sun
authors.forename: Jiamin
authors.initials: J
authors.lastname: Zhang
authors.forename: Yan
authors.initials: Y
authors.lastname: Liu
authors.forename: Jie
authors.initials: J
authors.lastname: Li
authors.forename: Hui
authors.initials: H
authors.lastname: Zhuang
mesh_terms: D000917:Antibody Formation; D002648:Child; D002675:Child, Preschool; D002681:China; D005260:Female; D006506:Hepatitis A / Q000276:immunology / Q000517:prevention & control; D035922:Hepatitis A Antibodies / Q000097:blood*; D022362:Hepatitis A Vaccines / Q000009:adverse effects / Q000276:immunology* / Q000627:therapeutic use*; D006801:Humans; D007115:Immunization Schedule; D007074:Immunoglobulin G / Q000276:immunology; D007223:Infant; D008297:Male; D016037:Single-Blind Method; D014611:Vaccination; D014613:Vaccines, Attenuated / Q000276:immunology / Q000627:therapeutic use; D015164:Vaccines, Inactivated / Q000276:immunology / Q000627:therapeutic use
chemical_list: D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D007074:Immunoglobulin G; D014613:Vaccines, Attenuated; D015164:Vaccines, Inactivated
keywords: immunogenicity; inactivated hepatitis A vaccine; live attenuated hepatitis A vaccine