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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 study the efficiency of booster immunization with different recombinant hepatitis B vaccines.Methods 2789 children aged over 10 years who had completed the basic immunization of hepatitis B vaccine under 1 year old were selected.All the sampled children were classified into four groups (A,B,C and D) and immunized with different hepatitis B vaccines produced by different campanies respectively.Before booster immunization,their blood plasma specimens were detected for hepatitis B virus (HBV) surface antigen (HBsAg),antibodies to HBV surface antigen (anti-HBs) and antibodies to HBV core antigen (anti-HBc) by chemiluminescence.In each group,the anti-HBs positive children were immunized with one dosage and anti-HBs negative children were immunized three dosages of the same vaccine.Their blood specimens were collected again after 1 month,and detected for anti-HBs.Results The anti-HBs positive rates of A,B,C and D group were 36.43%,37.59%,42.91% and 46.46% respectively before immunization while 89.20%,91.52%,90.96% and 85.45% respectively after immunization with one dosage,99.12%,99.47%,98.87% and 98.85% respectively after immunization with three dosages.The differences of anti-HBs positive rates in the four respective groups showed statistical significances between any two rates of pre-immunization,post-immunization with one dosage and post- immunization with three dosages (all P＜0.05).The anti-HBs positive conversion rates of four groups were 83.01%,86.41%,84.16% and 72.82% respectively after immunization with one dosage.The anti-HBs positive conversion rate of four groups were 98.62%,99.16%,98.03% and 97.84% respectively after immunization with three dosages and the difference of positive conversion rates in each group showed statistical significances between booster immunization with one dosage and booster immunization with three dosages.The average GMTs in anti-HBs positive children in the four groups were 2853.21,6254.23,3581.40 and 3021.32 mIU/ml respectively after immunization with one dosage.The average GMTs of anti-HBs negative children in the four groups were 273.08,648.52,387.87 and 245.36 mIU/ml respectively after immunization with one dosage,and were 632.30,2341.14,563.97 and 394.08 mIU/ml respectively after immunization with three dosages.Conclusion Our data showed that it would be suitable to anyone to use the four vaccines for anti-HBs positive children aged over 10 years with one dosage and for anti-HBs negative children aged over 10 years with three dosage booster immunization.
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<p><b>OBJECTIVE</b>To investigate the pathophysiological role of CXCL16 in immunological liver injury induced by Bacille de Calmette et Guerin (BCG) and lipopolysaccharides (LPS).</p><p><b>METHODS</b>Immunological liver injury was induced by BCG and LPS in mice, and the expression of CXCL16 was detected in the liver tissues by real-time quantitative PCR and immunohistochemical examination. The relationship of the expression of CXCL16 and the extent of hepatic necrosis was investigated histopathologically and immunohistochemically. Mononuclear cells were isolated from the liver tissues and their numbers were counted; T lymphocytes populations in the liver tissue were also analyzed with FACS.</p><p><b>RESULTS</b>The immunological liver injury model was successfully created. Up-regulation of CXCL16 in injured livers correlated with the extent of liver injury and the amountmononuclear cell infiltrations.</p><p><b>CONCLUSION</b>These findings suggest that up-regulation of CXCL16 was closely correlated with liver injury extent during the immunological liver injury induced by BCG-LPS in mice, and intrahepatic recruitment of specific lymphocytes might be an important mechanism of liver injury.</p>