title: A Randomized Controlled Trial to Evaluate a Potential Hepatitis B Booster Vaccination Strategy Using Combined Hepatitis A and B Vaccine.
abstract: Booster doses could play a major role in no responders or low responders to primary hepatitis B (HB) vaccine. Planed time point for hepatitis A vaccination in China provides a good opportunity to carry out HB booster dose by using combined hepatitis A and B vaccine.
  
  
  
  A randomized, double-blinded clinical trial was conducted to compare the immunogenicity and safety of toddlers 18-24 months of age receiving 3 different vaccination regimens: 2 doses of inactivated hepatitis A vaccine (group 1), 1 dose of inactivated hepatitis A vaccine plus 1 dose of combined hepatitis A and B vaccine (group 2) or 2 doses of combined hepatitis A and B vaccine (group 3).
  
  
  
  All 3 groups showed 100% seroprotection for antihepatitis A virus antibody after vaccination. Seroprotection rate for anti-HB antibody before vaccination ranged from 79.5% to 92.9% in the 3 groups. After second inoculation, anti-HBs seroprotection increased from 92.9% to 100% in group 2 with postvaccination geometric mean concentration (GMC) of 2258.3 mIU/mL and from 79.5% to 98.9% in group 3 with postvaccination GMC of 2055.3 mIU/mL. The adverse events were not statistically different among groups (P = 0.345).
  
  
  
  Combined hepatitis A and B vaccine could stimulate high level of both antihepatitis A virus and anti-HBs antibodies and not increase adverse events, providing a new choice for HB booster.
authors.affiliation: From the *Hunan Center for Disease Control and Prevention, Changsha, Hunan province, China; †Sinovac Biotech Ltd., Beijing, China; and ‡Chaling Center for Disease Control and Prevention, Zhuzhou, Hunan province, China.
authors.forename: Fangjun
authors.initials: F
authors.lastname: Li
authors.forename: Yuansheng
authors.initials: Y
authors.lastname: Hu
authors.forename: Youming
authors.initials: Y
authors.lastname: Zhou
authors.forename: Lixin
authors.initials: L
authors.lastname: Chen
authors.forename: Wei
authors.initials: W
authors.lastname: Xia
authors.forename: Yufei
authors.initials: Y
authors.lastname: Song
authors.forename: Zhengliang
authors.initials: Z
authors.lastname: Tan
authors.forename: Lidong
authors.initials: L
authors.lastname: Gao
authors.forename: Zhong
authors.initials: Z
authors.lastname: Yang
authors.forename: Gang
authors.initials: G
authors.lastname: Zeng
authors.forename: Xing
authors.initials: X
authors.lastname: Han
authors.forename: Junhua
authors.initials: J
authors.lastname: Li
authors.forename: Jing
authors.initials: J
authors.lastname: Li
mesh_terms: D002675:Child, Preschool; D002681:China; D004311:Double-Blind Method; D005260:Female; D006506:Hepatitis A / Q000517:prevention & control*; D035922:Hepatitis A Antibodies / Q000097:blood; D022362:Hepatitis A Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007117:Immunization, Secondary / Q000009:adverse effects / Q000379:methods*; D007223:Infant; D008297:Male; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D017778:Vaccines, Combined