title: [Study on the immuno-effects and influencing factors of Chinese hamster ovary (CHO) cell hepatitis B vaccine among adults, under different dosages].
abstract: OBJECTIVE
  To evaluate the immuno-effect and related influencing factors on 10 µg and 20 µg Chinese hamster ovary (CHO) cell hepatitis B vaccine, using the randomized double-blind controlled trials in adult population.
  
  
  METHODS
  A total of 642 adults aged 18 - 45 years old, non-vaccinated against hepatitis B, and negative on five blood indicators for hepatitis B, were selected as the study objects from four districts in Beijing. The study objects were randomly divided into two groups, and then accepted 10 µg and 20 µg recombinant CHO hepatitis B vaccination by 0 - 1 - 6 month schedule. Influencing factors were investigated by means of questionnaire. Blood samples were collected one month after the third dose of vaccination. Anti-HBs level was detected by Abott chemiluminescence detection method. For the anti-HBs negative person, fluorescent quantitative PCR method was used to find out if the person had been infected with HBV. Logistic regression analysis was used to find out the influencing factors of anti-HBs seroconversion on every studied subject.
  
  
  RESULTS
  The anti-HBs seroconversion rates on 10 µg and 20 µg dose groups were 88.8% (95%CI: 85.4% - 92.2%) and 95.3% (95%CI: 93.0% - 97.6%) respectively. Taking the anti-HBs level < 100 mIU/ml as the low/non-response standard, the low response and non-response rates were 34.3% and 17.4% respectively. The geometric mean titers (GMT) of anti-HBs were 173.42 mIU/ml for the 10 µg dose group and 588.51 mIU/ml for the 20 µg dose group. Data from the Multivariate analysis showed that:diabetes, spouses infected with hepatitis B virus and old age were unfavorable factors for anti-HBs Seroconversion. 20 µg dose of the vaccine was conducive to seroconversion.
  
  
  CONCLUSIONS
  20 µg CHO hepatitis B vaccine seemed better than 10 µg CHO hepatitis B vaccine while many factors need to be taken into account for evaluation on hepatitis B vaccines.
authors.affiliation: Beijing Center for Disease Control and Prevention, Beijing 100013 China.
authors.forename: Wei
authors.initials: W
authors.lastname: Zhang
authors.forename: Chang-ying
authors.initials: CY
authors.lastname: Lin
authors.forename: Li-li
authors.initials: LL
authors.lastname: Han
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: 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; D016466:CHO Cells; D006224:Cricetinae; D003412:Cricetulus; D004311:Double-Blind Method; D005260:Female; D006508:Hepatitis Antibodies / Q000097:blood; D006509:Hepatitis B / Q000276:immunology* / Q000517:prevention & control; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000276:immunology; D006801:Humans; D007117:Immunization, Secondary; D008297:Male; D008875:Middle Aged; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000276:immunology; D055815:Young Adult
chemical_list: D006508:Hepatitis Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D014614:Vaccines, Synthetic