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Objective To evaluate the safety of 60μg recombinant hepatitis B vaccine(Saccharomyces Cerecisiae)in healthy population over 16 years old and immunogenicity in non-responders.Methods A total of 4345 eligible subjects over 16 years old were selected and vaccinated with 60 μg recombinant hepatitis B vaccine, including 3415 participants who have never been vaccined before and 930 non-responders. All participants were monitored for any adverse events occurring within 30 min after each injection and instructed to record selected injection-site reactions and systemic reactions on the day of vaccination and the subsequent 28 days. Blood samples were collected from non-responders at pre-vaccination and one month after vaccination,in order to determine anti-HBs levels,positive rates of anti-HBs and the mean geometric titre(GMT)of anti-HBs.Results Among 4345 vaccinated participants,16.39 % of them reported at least one injection-site or systemic adverse reaction. The most common injection-site and systemic adverse reactions were Grade 1 adverse reactions with the incidence of 15.12 %(657/4345)and 4.05%(176/4345)respectively. No serious adverse events were observed. Among 930 non-responders,the positive rate of anti-HBs was 87.03 % with active responder of 76.74 %(551 / 718)and the GMT of anti-HBs was 479.28 mIU / ml. The positive rate of anti-HBs was not associated with gender or age (P>0.05). The GMT of anti-HBs demonstrated significant differences between female and male(560.66 mIU / mL VS. 404.91 mIU / mL,P<0.05),but there was no significant differences in different age groups (P>0.05).Conclusion 60μg recombinant hepatitis B vaccine was safe for healthy adults above 16 years and had good immunity efficacy among non-responders who had no or low response to standard immunization regimen of hepatitis B vaccine.
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Objective To evaluate the non-and-low response to primary immunization of recombinant yeast-derived hepatitis B vaccines (YDVs) among neonates and to probe its determinants, in Shanghai. Methods Two thousand and forty-seven infants, born during 2008-2009 in three districts of Shanghai and administered with 3 dosages of YDVs according to 0-1-6 month schedule, were selected as subjects. Anti-HBs titers were evaluated by Chemiluminescence Microparticle Immuno Assay and related information was collected from parents through questionnaires. Univariate analysis and logistic regression model were used to probe the determinants among those infants with non-and-low response. Results The max-titer of anti-HBs in 2047 subjects was 14 982.7 mIU/ml, whereas the min-titer was 0.52 mIU/ml. The GMC was 408.04 mIU/ml after primary immunization of YDVs. The proportion of infants with titers of ＜100 mIU/ml (non-and-low response) was 17％, in which the proportion with titers of ＜ 10 mIU/ml (non response)was 1.86％ and the proportion with titers of 10-99 mIU/ml (low response) was 15.14％. Data from both univariate analysis and Ordinal logistic regression suggested that gender, age, premature labor,type of vaccines, double positive for both HBsAg and HBeAg were determinants of non-and-low response for infants, with the OR value of 1.365 for male infants, 3.133 for infants with 13-18 months old, 2.824 fo r prematured infants, 4.540 for infants administered by 5 μg YDVs and 2.298 for infants whose mother was double positive for both HBsAg and HBeAg. Conclusion Male infants,infants with 13-18 months old, prematured infants, infants administered by 5 μg YDVs and infants whose mother were double positive for both HBsAg and HBeAg had comparatively worse response for YDVs, suggesting that the anti-HBs titer surveillance programs set for these infants should be strengthened.
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Objective To explore the failure factors of the immunization of hepatitis B vaccine,in order to provide evidence for adult hepatitis B vaccine immunization.Methods Random seleced the targets by examinations from susceptible population whose age were ≥18 years old,that immunized with 10?g Recombinant hepatitis B vaccine(YDV)three doses followng schedule of 0、1、6 months,then condcted a case-control study to the failure.Results Failure rate of adult administered with 10?g HepB immunity was 12.99%.Among the failures,smoking rate,obesity rate,family history hepatitis B virus infection rate and micro virus infection rate were higher than the control group.There was obvious statistic difference.Conclusion The adult failure factor of hepatitis B vaccine immunity was associated with smoking,obesity,hepatitis B viras infection,family history and micro virus infection.
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AIM:To investigate the efficacy of Bacillus Calmette-Guerin(BCG)on IL-12,IL-10 expressions of infants with none or low response to recombinant hepatitis B vaccine.METHODS:The geometric mean titer(GMT)of anti-HBs was tested by radio-immunity assay after hepatitis B vaccine stimulation,selected 60 cases with non-or low-response(GMT
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BACKGROUND: Green Cross HG-II vaccine is recombinant hepatitis B vaccine derived from yeast Hansenula polymorpha. Its immunogenicity and safety using 0-1-6 months vaccination schedule were proven. This prospective study is conducted to evaluate immunogenicity and safety of HG-II according to 0-1-2 months schedule. METHODS: 20 g of HG-II vaccine was given intramuscularly at 0, 1, and 2 months to 118 healthy adults seronegative for hepatitis B markers. Sera were assessed for anti-HBs by radioimmunoassay at 1 months and 7-10 months after completion of vaccination. RESULTS: 113 of 118 (95.8%) completed vaccination schedules. The seroconversion rate at 1 month after completion of vaccination was 93.8% (106/113) and protective titers of anti-HBs developed in 82.3% (93/113). The geometric mean titer (GMT) of anti-HBs was 64.91 mIU/ml in all seroconverted vaccinee. There was no incapacitating serious side effect associated with vaccinations. The seropositive rate at 7-10 months after vaccination was 95.3% (81/85) with protective rate of 84.7% (72/85). The anti-HBs titers were decreased in 51.8% (44/85) of vaccinee. The GMT was 80.04 mIU/ml. The protective rate and GMT were 98.0%, 129.43 mIU/ml in the group with anti-HBs titer > or = 50 mIU/ml at 1 month after vaccination, and 64.71%, 19.62 mIU/ml in the group with anti-HBs <50 mIU/ml. CONCLUSION: Green Cross HG-II vaccine is safe and effective in protecting hepatitis B at 0-1-2 months vaccination schedule. However, the booster injection should be recommended for maintenance of immunogenicity, especially in the vaccinee with anti-HBs titer less than 50 mIU/ml at 1 month after vaccination.
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Adult , Humans , Appointments and Schedules , Hepatitis B Vaccines , Hepatitis B , Hepatitis , Pichia , Prospective Studies , Radioimmunoassay , Vaccination , YeastsABSTRACT
BACKGROUND/AIMS: The introduction of Hansenula polymorpha for recombinant hepatitis B vaccine production allowed high product yield with plasmid stability and less glycosylation than conventional Saccharomyces cerevisiae system. A Green Cross HG-II vaccine formulated from HBsAg produced by a recombinant strain of the yeast H. polymorpha was evaluated for immunogenicity and safety in an open label triaL METHOFD: A 20 ug dose of Green Cross HG-II vaccine was administered intramuscularly at 0, 1 and 6 months at the deltoid region in 118 healthy adults seronegative for HBV markers. The anti-HBs titers were determined at one month after administration of the third dose of vaccine by radioimmunoassay. RESULTS: The seroconversion rate was 96.8% (90 out of 93), with seroprotective rate of 95.7% (89 out of 93). The geometric mean titers(GMT) of the anti-HBs response was 153.1mIU/ml in seroconverters. An age-dependent effect was observed in the anti-HBs response. But sex-dependent effect was not prominent. Reactogenecity was in incidence and general reactions were short-lasting and a mainly mild in severity. CONCLUSIONS: The results of this study have shown that the Green Cross HG-II vaccine is safe and clinically well tolerated, a nd that it may provide protection against HBV infection.