重组戊型肝炎疫苗应用于16~65岁人群的安全性及免疫原性研究

目的 评价长春生物制品研究所有限责任公司研制的重组戊型病毒性肝炎（戊肝）疫苗用于16~65周岁人群免疫的临床安全性与免疫原性。方法 先筛选出戊肝抗体阴性者作为试验目标人群，再采用单中心、随机、盲法、同类制品平行对照的试验设计，选择戊肝抗体阴性的16~65周岁健康受试者60人，按1：1的比例随机接种试验疫苗和阳性对照疫苗，免疫程序均为0，1，6月程序，记录每针次接种后28 d内的不良反应/事件发生情况。采集免疫接种前和全程免疫接种后1个月的血液标本，进行戊肝IgG浓度检测。结果 招募369名受试者，经筛查戊肝抗体阴性者有187人，最终入组60人。试验组和阳性对照组免疫接种后总体征集性不良反应发生率分别为43.33%和40.00%，严重程度以轻、中度为主，最常见接种部位和全身不良反应分别为疼痛和头痛，不良反应的发生在组间差异均无统计学意义（均有P>0.05）。免疫后试验组与阳性对照组戊肝抗体阳性率均达到100%，抗体几何平均浓度（geometric mean concentration，GMC）分别为72.53 U/ml和87.49 U/ml。结论 试验疫苗具有良好的安全性和免疫原性，可以开展Ⅱ期临床试验。

Safety and immunogenicity of a domestic recombinant hepatitis E vaccine in a 16-65 years old population

Objective To clinically evaluate the safety and immunogenicity of the recombinant hepatitis E vaccine developed by Changchun Biological Products Research Institute Company Limited in a population aged 16 to 65 years old. Methods We first selected subjects who were HEV antibody negative as a target population by screening. Then, a single center, randomized, blind trial with a similar product as a parallel control was conducted that sixty 16-65 years old healthy subjects who were HEV antibody negative were randomized to receive study vaccines or controlled vaccines by the ratio of 1:1. The immunization schedule consisted of 3 doses given on month 0, month 1 and month 6. Adverse reactions/events within 28 days after each dose were recorded. Hepatitis E IgG concentrations were detected with blood samples collected before immunization and 1 month after full schedule. Results We recruited 369 subjects. Among them, 187 were hepatitis E antibody negative after screening, and 60 subjects were enrolled in the trial eventually. Overall incidence of solicited adverse effects after 3 doses vaccination in the test group and the control group were 43.33% and 40.00% respectively. Majority of the adverse effects were mild and moderate. The most common injection-site and systemic reactions were pain and headache. The occurrence rates of adverse effects were not significantly different between groups (all P>0.05). Seropositive rates of HEV antibody after vaccination in the test group and the control group were both 100% and GMCs were 72.53 U/ml and 87.49 U/ml respectively. Conclusion The test vaccine has good safety and immunogenicity and a phase Ⅱ clinical trial can be carried out.