title: [Study on the cellular and humoral immunity effect of recombinant Chinese hamster ovary cell hepatitis B vaccine in adults].
abstract: OBJECTIVE
  To evaluate the cellular and humoral immunity effect of 10 µg and 20 µg recombinant Chinese hamster ovary (CHO) cell hepatitis B vaccine in adults by randomized double-blind controlled trials.
  
  
  METHODS
  A total of 642 adults aged 18 - 45 years old, non-vaccinated against hepatitis B, and hepatitis B five blood indicators negative were selected as the study subjects. The study subjects were randomly divided into two groups and each group had 321 subjects. The subjects were given 10 µg and 20 µg recombinant CHO hepatitis B vaccination respectively by 0, 1st, 6th month schedule. Blood sample was collected from each study subject one month after the second dose vaccination. The anti-HBs level was detected by Abbott chemiluminescence detection method (I2000) to evaluate humoral immunity status. Of all the study objects, 153 cases were randomly selected by the Excel random function. Their blood samples were collected and Lymphocyte were separated to detect the IL-4 and IFN-γ levels in vitro by enzyme-linked immunospot (ELISPOT) method to evaluate the cellular immunity status.
  
  
  RESULTS
  The anti-HBs seroconversion rates in 10 µg and 20 µg dose group were 88.8% (285/321) and 95.3% (306/321) respectively, and 95%CI were 85.4% - 92.2% and 93.0% - 97.6% respectively. The spot forming cell (SFC) of IL-4 of the 20 µg-dose group (x(-) = 20.31) were significantly higher than the 10 µg-dose group (x(-) = 8.19, t = 3.27, P < 0.01). With the increasing of anti-HBs titer, the SFC of IL-4 also went up significantly. There was a positive correlation between SFC of IL-4 and anti-HBs (Spearman correlation coefficient = 0.538, P < 0.0001). No significant difference was found for IFN-γ SFC in two groups (10 µg group: x(-) = 1.49; 20 µg group: x(-) = 0.86; t = 1.83, P > 0.05).
  
  
  CONCLUSIONS
  The humoral and cellular immune effects of 20 µg recombinant CHO hepatitis B vaccine are better than that of the 10 µg recombinant CHO hepatitis B vaccine.20 µg recombinant CHO hepatitis B vaccine should be chosen as the adult's hepatitis B prevention vaccine.
authors.affiliation: Beijing Center for Disease Control and Prevention, Beijing, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Zhang
authors.forename: Li-li
authors.initials: LL
authors.lastname: Han
authors.forename: Chang-ying
authors.initials: CY
authors.lastname: Lin
authors.forename: Li-qiu
authors.initials: LQ
authors.lastname: Li
authors.forename: Pei
authors.initials: P
authors.lastname: Gao
authors.forename: Hui
authors.initials: H
authors.lastname: Lin
authors.forename: Xiao-hong
authors.initials: XH
authors.lastname: Gong
authors.forename: Fang
authors.initials: F
authors.lastname: Huang
authors.forename: Ya-qing
authors.initials: YQ
authors.lastname: Tang
authors.forename: Jian-xin
authors.initials: JX
authors.lastname: Ma
authors.forename: Hai-yan
authors.initials: HY
authors.lastname: Zhang
authors.forename: Chen
authors.initials: C
authors.lastname: Wang
authors.forename: Peng
authors.initials: P
authors.lastname: Yang
authors.forename: Hui
authors.initials: H
authors.lastname: Li
authors.forename: Jiang
authors.initials: J
authors.lastname: Wu
authors.forename: Mei-ping
authors.initials: MP
authors.lastname: Sun
authors.forename: Xiong
authors.initials: X
authors.lastname: He
authors.forename: Xing-huo
authors.initials: XH
authors.lastname: Pang
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D000917:Antibody Formation; D016466:CHO Cells; D006224:Cricetinae; D003412:Cricetulus; D004311:Double-Blind Method; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000276:immunology*; D006801:Humans; D007111:Immunity, Cellular / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines