title: [Comparison on the antibody response after primary immunization of 5 µg and 10 µg hepatitis B vaccine made by recombinant DNA techniques among newborns].
abstract: OBJECTIVE
  To compare the antibody response induced by primary immunization with 5 µg and 10 µg hepatitis B vaccine made by recombinant DNA techniques among the newborns.
  
  
  METHODS
  Healthy infants who had completed primary immunization with 5 µg hepatitis B vaccine made by recombinant dexyribonucleic acid techniques in Saccharomyces (Hep-SC) or 10 µg hepatitis B vaccine made by recombinant dexyribonucleic acid techniques in Hansenula polymorpha (HepB-HP) were included in the study. Kids under study were 7-12 months of age and had been on 0-1-6 schedule. Standardized questionnaire was used and blood samples were collected. The titer of antibody to hepatitis B surface antigen (anti-HBs) was detected by Chemiluminescence Microparticle Imunoassay (CMIA). If anti-HBs happened to be under 10 mIU/ml, HBV DNA was further detected by nested-PCR to distinguish occult hepatitis B virus infection. Sero-conversion rate and titer of anti-HBs were compared between the two kinds of hepatitis B vaccines. Multivariate analysis was used to find the relationship between the kind of hepatitis B vaccine as well as the antibody response after debugging the other influencing factors including month-age, gender, birth-weight, premature birth and mother's HBsAg status.
  
  
  RESULTS
  8947 infants vaccinated with 5 µg HepB-SC and 4576 infants vaccinated with 10 µg HepB-HP were investigated. In the 5 µg group, the rates of non-, low-, normal- and high-response were 1.88%, 15.18%, 61.42% and 21.52% respectively. In the 10 µg group, the corresponding rates were 0.15%, 2.16%, 29.42% and 68.26% respectively. The non-, low-, normal-response rates were all higher in 5 µg group than in 10 µg group (P<0.01), while the high-response rate was much higher in 10 µg group than in 5 µg group (P<0.01). The geometric mean concentration (GMC) of anti-HBs were 354.81 mIU/ml (95%CI: 338.84-363.08 mIU/ml) and 1778.28 mIU/ml (95%CI: 1698.24-1819.70 mIU/ml) in the 5 µg group and 10 µg group respectively. The GMC was statistically higher in the 10 µg group than in the 5 µg group (P<0.001). The sero-conversion rate and GMC were significantly different between the two groups even after debugging the other influencing factors.
  
  
  CONCLUSIONS
  Better anti-HBs response could be achieved by primary immunization with 10 µg HepB-HP than with 5 µg HepB-SC among newborns.
authors.affiliation: Shandong Provincial Center for Disease Control and Prevention, Ji'nan 250014, China.
authors.forename: Li
authors.initials: L
authors.lastname: Zhang
authors.forename: Wei
authors.initials: W
authors.lastname: Zhang
authors.forename: Xiang-jun
authors.initials: XJ
authors.lastname: Zhai
authors.forename: Yan-ping
authors.initials: YP
authors.lastname: Li
authors.forename: Jian
authors.initials: J
authors.lastname: Li
authors.forename: Bing-yu
authors.initials: BY
authors.lastname: Yan
authors.forename: Yan-ting
authors.initials: YT
authors.lastname: Li
authors.forename: Feng-cai
authors.initials: FC
authors.lastname: Zhu
authors.forename: Teng
authors.initials: T
authors.lastname: Huang
authors.forename: Li-qiu
authors.initials: LQ
authors.lastname: Li
authors.forename: Xiao-hong
authors.initials: XH
authors.lastname: Gong
authors.forename: Fu-qiang
authors.initials: FQ
authors.lastname: Cui
authors.forename: Xiao-feng
authors.initials: XF
authors.lastname: Liang
authors.forename: Ai-qiang
authors.initials: AQ
authors.lastname: Xu
mesh_terms: D000917:Antibody Formation; D005260:Female; D006510:Hepatitis B Antibodies / Q000097:blood*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000276:immunology; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D015999:Multivariate Analysis; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000276:immunology
chemical_list: D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D014614:Vaccines, Synthetic