title: Comparative immunogenicity of hepatitis B vaccine with different dosages and schedules in healthy young adults in China.
abstract: OBJECTIVE
  To compare immunogenicity of hepatitis B vaccine between the standard 3-dose (20 μg) and 2-dose with higher-dosage (60 μg) regimens in healthy young adults and evaluate the safety profile.
  
  
  METHODS
  A randomized, parallel-group clinical trial was conducted among healthy young adults aged 18-25 years. Subjects were randomly assigned to three groups. One group was administered hepatitis B vaccine with the standard regimen of 0-1-6 month (20 μg) and other groups were immunized with regimens of 0-1 or 0-2 month (60 μg) respectively. Serum samples were collected at 1 month after a series vaccination and 12 months after the first-dose inoculation for anti-HBs antibody measurement with a Chemiluminescent Microparticle ImmunoAssay (CMIA).
  
  
  RESULTS
  The seroprotection rates in 20 μg (0-1-6 month), 60 μg (0-1 month) and 60 μg (0-2 month) groups were 100, 93.64 and 99.19% at month 7/2/3, and 100, 96.04 and 95.90% at month 12, respectively. There were no significant differences among three vaccine groups (p>0.05). The geometric mean concentration (GMC) of anti-HBs was significantly higher in 20 μg (0-1-6 month) group than that in 60 μg (0-1 month) group at month 7/2 (1847.99 vs. 839.27 mIU/ml, p=0.004), but was similar to that in 60μg (0-2 month) group at month 7/3 (1847.99 vs. 1244.80 mIU/ml, p=0.138). At month 12, the GMC in 20 μg (0-1-6 month) group was significantly higher than those of other groups (1456.63 vs. 256.30, 235.15 mIU/ml, respectively, p<0.001). The total incidence of injection-site or systemic adverse reactions was <3%.
  
  
  CONCLUSIONS
  A 2-dose with higher-dosage hepatitis B vaccine regimens are comparable to the standard 3-dose regimen in terms of immunogenicity except a relatively rapid decline in GMC levels which are associated with the longevity of protection. All formulations of hepatitis B vaccine were well tolerated. CLINICALTRIALS.GOV IDENTIﬁER: NCT02203357.
authors.affiliation: Department of Microbiology and Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing 100191, China.
authors.forename: Zhen-Zi
authors.initials: ZZ
authors.lastname: Wang
authors.affiliation: Liuzhou Municipal Center for Disease Control and Prevention, Liuzhou 545007, Guangxi, China.
authors.forename: Ming-Qiang
authors.initials: MQ
authors.lastname: Li
authors.affiliation: Liuzhou Municipal Center for Disease Control and Prevention, Liuzhou 545007, Guangxi, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Wang
authors.affiliation: Liuzhou Municipal Center for Disease Control and Prevention, Liuzhou 545007, Guangxi, China.
authors.forename: Zhen-Xing
authors.initials: ZX
authors.lastname: Yang
authors.affiliation: Liuzhou Municipal Center for Disease Control and Prevention, Liuzhou 545007, Guangxi, China.
authors.forename: Lin
authors.initials: L
authors.lastname: Wei
authors.affiliation: Shenzhen Kangtai Biological Products Co., LTD., Shenzhen 518057, Guangdong, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Zeng
authors.affiliation: Guangxi Provincial Centers for Disease Control and Prevention, Nanning 530028, Guangxi, China.
authors.forename: Yan-Ping
authors.initials: YP
authors.lastname: Li
authors.affiliation: Department of Microbiology and Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing 100191, China.
authors.forename: Ling
authors.initials: L
authors.lastname: Yan
authors.affiliation: Department of Microbiology and Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing 100191, China. Electronic address: xueenliu@bjmu.edu.cn.
authors.forename: Xue-En
authors.initials: XE
authors.lastname: Liu
authors.affiliation: Department of Microbiology and Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing 100191, China. Electronic address: zhuangbmu@126.com.
authors.forename: Hui
authors.initials: H
authors.lastname: Zhuang
mesh_terms: D000293:Adolescent; D000328:Adult; D002681:China; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage*; D006801:Humans; D007115:Immunization Schedule; D008297:Male; D055815:Young Adult
chemical_list: D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines
keywords: Hepatitis B Vaccine; Hepatitis B virus; High dosage; Immunogenicity; Young adults