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. METHOD: 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). CONCLUSION: 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.
Subject(s)
Antibody Formation , Hepatitis B Vaccines/immunology , Hepatitis B/prevention & control , Immunity, Cellular/immunology , Adolescent , Adult , Animals , CHO Cells , Cricetinae , Cricetulus , Double-Blind Method , Female , Hepatitis B Antibodies/blood , Hepatitis B Antibodies/immunology , Hepatitis B Vaccines/administration & dosage , Humans , Male , Middle Aged , Young AdultABSTRACT
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. CONCLUSION: 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.
Subject(s)
Hepatitis B Vaccines/administration & dosage , Hepatitis B/immunology , Adolescent , Adult , Animals , CHO Cells , Cricetinae , Cricetulus , Double-Blind Method , Female , Hepatitis Antibodies/blood , Hepatitis B/prevention & control , Hepatitis B Surface Antigens/immunology , Hepatitis B Vaccines/immunology , Humans , Immunization, Secondary , Male , Middle Aged , Vaccines, Synthetic/administration & dosage , Vaccines, Synthetic/immunology , Young AdultABSTRACT
OBJECTIVE: To explore the serological infection rate of hepatitis B virus (HBV) in general population aged over one year old in Beijing and to provide information for control and prevention of the disease. METHODS: A multistage randomized cluster sampling was carried out in general population of Beijing, aged over one year old. Every study subject's hepatitis B immunization history and main risk factors were investigated through questionnaire. Venous blood samples were collected and then tested for five hepatitis B serological antigens and antibodies by means of Abbott Microparticle Enzyme Immunoassy method. RESULTS: The prevalence rates of HBsAg, anti-HBs, anti-HBc and total HBV infection rate were 3.49% (95% CI:2.99-3.99), 37.79% (95% CI: 36.46-39.12), 35.04% (95% CI: 33.72-36.35) and 35.09% (33.78-36.40) respectively. The age standardized rates were 3.02% ,42.47% ,26.86% and 26.90% respectively. CONCLUSION: Achievement in hepatitis B control and prevention was made in Beijing since the prevalence rate of hepatitis B surface antigen had been below 1% for children aged less than 5 years old. As for the general population, the prevalence rate of hepatitis B surface antigen had reduced to
