文章摘要
梁 祁,戴启刚,顾晟年,王诗远,李洪光,彭志行,胡月梅.国产吸附破伤风疫苗用于成人加强免疫的安全性及免疫原性观察[J].南京医科大学学报,2015,(1):51~57
国产吸附破伤风疫苗用于成人加强免疫的安全性及免疫原性观察
Safety and immunogenicity of booster dose of adsorbed tetanus vaccine in adults
投稿时间:2014-05-12  
DOI:10.7655/NYDXBNS20150111
中文关键词: 吸附破伤风疫苗  安全性  免疫原性  加强免疫
英文关键词: adsorbed tetanus vaccine  safety  immunogenicity  booster immunization
基金项目:
作者单位
梁 祁 江苏省疾病预防控制中心急性传染病防制所,江苏 南京 210009 
戴启刚 江苏省疾病预防控制中心急性传染病防制所,江苏 南京 210009 
顾晟年 盐城市盐都区疾病预防控制中心,江苏 盐城 224000 
王诗远 东南大学公共卫生学院,江苏 南京 210009 
李洪光 成都欧林生物科技股份有限公司,四川 成都 611731 
彭志行 南京医科大学公共卫生学院,江苏 南京 210029 
胡月梅 江苏省疾病预防控制中心急性传染病防制所,江苏 南京 210009 
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中文摘要:
      目的:评价成都欧林生物科技股份有限公司研制的吸附破伤风疫苗用于成人加强免疫的临床安全性与免疫原性。方法:分两阶段开展:第一阶段采用开放性设计,评价试验疫苗的安全性,在确认安全性的情况下开展第二阶段试验;第二阶段采用单中心?随机?盲法?同类制品平行对照的试验设计,选择18~30岁的常住健康人群,按1∶1的比例随机接种试验疫苗和阳性对照疫苗,使用日记卡记录接种后28 d内的不良反应/事件发生情况。采集免疫前和免疫后28 d的血液标本,使用标准酶联免疫吸附试验方法进行破伤风类毒素抗体浓度检测。结果:第一阶段招募30名受试者,试验疫苗接种后7 d内总体不良反应为33.3%;第二阶段试验组和阳性对照组各入组600人,总体不良反应发生率分别为30.7%和31.5%,以轻中度不良反应为主,最常见接种局部和全身不良反应分别为疼痛和发热,不良反应的发生在组间差异无统计学意义(P ≥ 0.05)。加强免疫后试验组与阳性对照组均诱导较强的免疫反应:破伤风抗体浓度达到保护性水平的受试者比例均达到100%,GMC分别为3.38?3.16 U/ml。结论:成都欧林生物科技股份有限公司研制的吸附破伤风疫苗具有良好的安全性和免疫原性,适用于成人进行加强免疫和进一步进行联合疫苗的研制。
英文摘要:
      Objective: To evaluate the safety and immunogenicity of booster immunization of adsorbed tetanus vaccine developed by Olymvax Biological Technology co., LTD in adults. Methods: This study was divided into two phases. For the first phase, openly design was adopted to evaluate the safety of experimental vaccine and the second phase would be performed if the vaccine was confirmed to be safety. The second phase of this study was designed to be a single center, randomized, double-blinded, paralleled controlled clinical trial. Health residents aged 18 to 30 years old were recruited to receive one dose of experimental adsorbed tetanus vaccine and control vaccine. Daily diary was used to collect safety data. Blood samples were collected right before and 28 days after vaccination for Tetanus toxoid antibody detection through standard enzyme linked immunosorbent assay. Results: Thirty participants were enrolled in the first phase of clinical trial. Frequency of total adverse reactions (AR) observed within 7 days after vaccination was 33.3%. In the second phase of clinical trial,1 200 participants were enrolled with 600 participants in experimental vaccine and control group, respectively. Incidences of total AR were 30.7% and 31.5% for vaccine and control group, respectively. Most common injection-site AR was pain, while most common systemic AR was fever. No statistically significant differences of frequencies of AR were found between treatment groups. For both group, good immunological response was induced, with proportion of participants with antibody concentration ≥0.1 U/ml for both groups up to 100% and GMCs were 3.38 U/ml and 3.16 U/ml, respectively. Conclusion: Adsorbed tetanus vaccine developed by Olymvax Biological Technology co., LTD showed good safety and immunogenicity, which is applicable for booster immunization for adults, and for further developing of combined vaccine.
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