文档介绍：中文摘要 I 摘要本研究通过大规模的临床试验,评估口蹄疫O型、亚洲Ⅰ型二价灭活疫苗的安全性、效力及群体免疫动物免疫持续期的免疫水平和免疫效果。采用了我们与新疆畜牧科学院兽医研究所和新疆天康畜牧生物技术股份有限公司合作研制生产的3批成品牛口蹄疫O型、Asia Ⅰ型二价灭活疫苗(新疆自治区高技术研究发展计划项目,编号 200511101) ,按超剂量和常规免疫剂量对靶动物牛和羊进行安全性试验。结果显示,3批疫苗对靶动物牛和羊安全,无论重复多次接种,还是怀孕牛、羊和幼龄牛、羊的一次性常规免疫剂量接种,均没有引起接种牛和羊的不良反应。通过对2批中试疫苗和3批成品疫苗的效力检验,5批疫苗效力每剂量均≥3PD 50,达到国际兽医局对口蹄疫产品的规定。 2批中试疫苗免疫两个地区的不同种牛后, 用液相阻断酶联免疫吸附试验(LBE) 检测,其产生的免疫抗体水平10~30天内口蹄疫O型和亚洲I型2种抗体滴度处于最高,~~92 ,抗体滴度超过1∶1024。接种靶动物30天以后抗体水平持续下降,约90~180天时呈现平缓的下降趋势,~ ~。免疫后5~6个月的抗体水平,高于免疫前的水平。免疫前基础抗体水平较高者,免疫后的抗体产生水平与维持水平也较高。两个地区免疫牛在接种后30天时口蹄疫O 型和亚洲I型抗体达到99%%-88. 24%和100%-%, 在免疫后的180 天内,%%,而亚洲I型口蹄疫抗体处于完全不保护的牛极少为0-%。关键词:口蹄疫O型、亚洲Ⅰ型二价灭活疫苗,安全性,免疫持续期英文摘要 II Abstract This paper is based on the results of large scale clinical experiment. For assessing the safety of three batch of inactivated ine, we use the three batch of divalent inactivated ine of O type and Asia I type of bovine Foot and mouth disease virus (FMDV) which produced by Xinjiang Tiankang Animal Science Bio. & Tec. Co., Ltd inoculate target animal includes cattle and sheep. The results shows that this three batch of ine are safe to target animals no matter what the ine are immuned repeatedly or immuned with pregnant animals or young animals. Testing the efficacy by using two batch of ine trial production and the three batch of ine mentioned above, the efficacy of these ine all ≥3PD 50 per dose over the requirements of OIE. By LBE tests, the quantity of antibody reach maximum after immuning 10-30 days in bilo cation bull with two batch of ine trial production. Geom etric average are between ~ and ~. Antibody titer is over 1 ∶1024. After immuning 30 days, the antibody titer has been a steady decrease, and 90 days it descended gradually with the geometric a