title: Comparing live attenuated and inactivated hepatitis A vaccines: an immunogenicity study after one single dose.
abstract: BACKGROUND
  While three types of hepatitis A vaccines are available in China, little data are available to compare them in terms of early antibody response. We conducted a trial to compare antibody response at 7, 14 and 28 days.
  
  
  METHODS
  We randomized primary school children in Gansu and Jilin provinces into four groups to receive either (1) Chinese live attenuated hepatitis A vaccine (H2 strain), (2) domestic inactivated hepatitis A vaccine (Healive(®)), (3) imported inactivated hepatitis A vaccine (Havrix(®)) or (4) hepatitis B vaccine (Control group). We compared groups at 7, 14 and 28 days in terms of proportion of sero-conversions (≥10 mUI/ml), and Geometric Mean Concentration (GMC) of antibodies measured with a Microparticle Enzyme Immunoassay (MEIA). We compared rates of self-reported adverse events following immunization (AEFI) in the first three days.
  
  
  RESULTS
  204 children received the H2 vaccine, 208 received Healive(®), 214 received Havrix(®), and 215 received hepatitis B vaccine (no differences across groups in terms of age, sex, weight and height). At seven days, sero-conversion proportions were 25%, 35%, 27% and 2% (p<0.0001) with GMC of 6 mIU/ml, 8 mIU/ml, 6 mIU/ml and 3 mIU/ml, respectively for the four groups. At 28 days, sero-conversion proportions were 98%, 100%, 93% and 3% (p<0.0001) with GMC of 47 mIU/ml, 71 mIU/ml, 67 mIU/ml and 3 mIU/ml, respectively. AEFI were benign and did not differ across groups (p=0.94).
  
  
  CONCLUSIONS
  While our study was not able to identify differences between Havrix(®), Healive(®) and H2 vaccine in terms of sero-conversion proportion and GMC between seven and 28 days, further studies should evaluate non-inferiority or equivalence of the Chinese vaccines, particularly with respect to the GMC concentration for the H2 vaccine since it could affect long-term protection.
authors.affiliation: Chinese Center for Disease Control and Prevention, Beiijng, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Zheng
authors.forename: Yuansheng
authors.initials: Y
authors.lastname: Chen
authors.forename: Fuzhen
authors.initials: F
authors.lastname: Wang
authors.forename: Xiaohong
authors.initials: X
authors.lastname: Gong
authors.forename: Zhenhua
authors.initials: Z
authors.lastname: Wu
authors.forename: Ning
authors.initials: N
authors.lastname: Miao
authors.forename: Xiaoshu
authors.initials: X
authors.lastname: Zhang
authors.forename: Hui
authors.initials: H
authors.lastname: Li
authors.forename: Chao
authors.initials: C
authors.lastname: Chen
authors.forename: Xiang
authors.initials: X
authors.lastname: Hou
authors.forename: Fuqiang
authors.initials: F
authors.lastname: Cui
authors.forename: Huaqing
authors.initials: H
authors.lastname: Wang
mesh_terms: D000293:Adolescent; 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 / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D006801:Humans; D008297:Male; D016037:Single-Blind Method; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D017325:Hepatitis B Vaccines; D014613:Vaccines, Attenuated; D015164:Vaccines, Inactivated