[Study on the immunogenicity and safety of recombinant B-subunit/whole cell cholera vaccine infused with antacids in healthy population at ages of 2-6 years].

Article

作者: Li, R C ; Liu, D P ; Huang, T

目的： 评价重组B亚单位/菌体霍乱疫苗在2~6岁健康人群中的免疫原性和安全性。 方法： 于2009年12月至2010年1月，采用发放招募通知的方法，在广西崇左辖区内的各疫苗接种点招募2~6岁儿童家长，共900名。采用随机、双盲、安慰剂对照的设计，将其按2∶1的比例随机接受以抗酸剂冲服霍乱疫苗（试验组）或安慰剂（安慰剂组）。采集入组的前300例（试验组200例，安慰剂组100例）对象首剂免疫前后第49天（±3 d）的血样，用ELISA检测血清中的抗霍乱毒素抗体（抗-CT）与杀弧菌抗体（抗-Vab）几何平均滴度（GMT），最终具有免疫前后配对血清者有266例（试验组177例，安慰剂组89例）。采用t比较两组对象入组时的年龄和免疫前后GMT水平差异；采用χ(2)检验比较两组性别构成、不良反应发生率以及抗体阳转率的率差差异。 结果： 900名调查对象中，男、女人数分别为503和397名（试验组为335和265名，对照组为168和132名），入组时试验组年龄为（4.8±1.2）岁，安慰剂组为（4.9±1.2）岁，两组间性别及年龄构成差异均无统计学意义（χ(2)=0.00，P=1.000；t=0.55，P=0.585）。免疫后试验组抗-CT与抗-Vab的2倍增长率分别为90.96%、57.63%，均高于安慰剂组的15.73%和29.21%（χ(2)值分别为15.89和3.85，P值均<0.001）。免疫后试验组抗-CT与抗-Vab的GMT水平分别为1∶647.56、1∶16.19，安慰剂组分别为1∶99.49和1∶11.27（t值分别为15.82和3.43，P值均<0.05），试验组较免疫前增长6.63和1.64倍，安慰剂组增长1.11和1.16倍（t'值分别为17.85和4.96，P值均<0.001）。试验组与安慰剂组不良反应发生率分别为37.67%（226/600）、36.67%（110/300），主要不良反应有发热、恶心、呕吐、腹痛、腹泻、头痛、乏力、过敏、皮疹等，程度主要为轻度（1级）。 结论： 重组B亚单位/菌体霍乱疫苗，用抗酸剂服法能够产生良好的免疫应答，且有较好的安全性。.

2012-12-01·Biotechnology Letters4区 · 工程技术

Effect of immunization with a recombinant cholera toxin B subunit/somatostatin fusion protein on immune response and growth hormone levels in mice

4区 · 工程技术

Article

作者: Ruili Qi ; Weifen Li ; Jun He ; Taoyan Yuan ; Dong Niu ; Bingbing Wu ; Yan Fu

Somatostatin (SS) is a hormone that inhibits growth hormone secretion. Cholera toxin B subunit (CTB) is a widely used adjuvant to improve the immunogenicity of co-administrated antigen. To block the growth hormone-inhibiting effect of SS, a fusion gene of CTB and SS was constructed and expressed in Escherichia coli. The purified CTB/SS fusion protein polymerized into a biologically active pentamer required for CTB binding to the GM1 ganglioside receptor. Immunization with the CTB/SS protein induced specific immunity against CTB and SS in mice. The serum growth hormone of the CTB/SS-treated mice increased by 29 % (P < 0.05) compared with the control. The results indicated that the CTB/SS fusion protein was effective in inducing immune response against SS as well as elevating the growth hormone level.

2009-12-01·BMC Infectious Diseases3区 · 医学

Effectiveness and economic analysis of the whole cell/recombinant B subunit (WC/rbs) inactivated oral cholera vaccine in the prevention of traveller's diarrhoea

3区 · 医学

ArticleOA

作者: Rosa Diez-Diaz ; Emilia Reina ; Rosa López-Gigosos ; Maria J Calvo ; Elena Plaza ; Pedro Garcia-Fortea

BACKGROUNDNowadays there is a debate about the indication of the oral whole-cell/recombinant B-subunit cholera vaccine (WC/rBS) in traveller's diarrhoea. However, a cost-benefit analysis based on real data has not been published.METHODSA cost-effectiveness and cost-benefit study of the oral cholera vaccine (WC/rBS), Dukoral for the prevention of traveller's diarrhoea (TD) was performed in subjects travelling to cholera risk areas. The effectiveness of WC/rBS vaccine in the prevention of TD was analyzed in 362 travellers attending two International Vaccination Centres in Spain between May and September 2005.RESULTSThe overall vaccine efficacy against TD was 42,6%. Direct healthcare-related costs as well as indirect costs (lost vacation days) subsequent to the disease were considered. Preventive vaccination against TD resulted in a mean saving of 79.26 euro per traveller.CONCLUSIONAccording to the cost-benefit analysis performed, the recommendation for WC/rBS vaccination in subjects travelling to zones at risk of TD is beneficial for the traveller, regardless of trip duration and visited continent.

100 项与重组B亚单位/菌体霍乱疫苗 (上海联合赛尔) 相关的药物交易

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