重组B亚单位/菌体霍乱疫苗以抗酸剂冲服对2～6岁健康人群的免疫原性和安全性研究  

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

作　　者：黄腾[1] 李荣成[1] 刘德平[2] 

机构地区：[1]广西壮族自治区疾病预防控制中心疫苗临床研究所,南宁530028 [2]崇左市疾病预防控制中心

出　　处：《中华预防医学杂志》2017年第9期827-831,共5页Chinese Journal of Preventive Medicine

摘　　要：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χ2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（χ2=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％（χ2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.Objective To assess the immunogenicity and safety of recombinant B-subunit/whole cell cholera vaccine （rBS/WC） oral cholera vaccine （Ora Vacs） infused with antacids in healthy population at ages of 2-6 years. Methods Between December 2009 and January 2010, we recruited 900 volunteers aged 2-6 years od through giving out recruitment notice for the eligible children＆#39;s parents from different vaccination clinics of Chongzuo city in Guangxi Zhuang Autonomous Region. This study was a randomized, double-blind, placebo-controlled trial, and subjects were randomly （2：1） assigned to receive Cholera vaccine infused with antacids or placebo, and observed for safety. Serum samples of 300 subjects in immunogenicity subgroups （200 for vaccine groups, 100 for control groups） before the 1st dose and 49 d （± 3 d） after immunization were collected, and determined for antibody levels against the cholera toxin （anti-CT） and cholera vibriocidal （anti-Vab） with Enzyme-linked immunosorbent assays （ELISA）, based on which the GMT was calculated. There were 266 cases paired with the serum samples before and after immunization （177 for vaccine groups, 89 for control groups）. The comparison of subjects＆#39; age at enrollment and the level of GMT before and after immunization between groups were analyzed by t test. The superiority test for the difference between seroconversion rates of vaccine groups and control groups were analyzed by χ2 test. Results Of 900 subjects enrolled, the number of males and females were 503 and 397 respectively （vaccine groups 335 vs. 265, control groups 168 vs. 132）, the average ages of vaccine groups and control groups at enrollment were （4.8 ± 1.2） years and （4.9 ± 1.2） years respectively. There were no significant differences between groups in terms of gender and age （χ2=0.00,P=1.000; t=0.55, P=0.585）. The 2 times increase rates of anti-CT and anti-Vab in vaccine groups after inoculation were 90.96%and 57.63%respectively, which were superiority

关 键 词：霍乱菌苗 免疫 药物评价 

分 类 号：R186[医药卫生—流行病学]