双佐剂口蹄疫A型、O型和亚洲Ⅰ型三价灭活疫苗的临床试验

Clinical Trials of Foot and Mouth Disease Trivalence Inactivated Vaccine(Type A,O and Asia Ⅰ)with Double Adjuvants

对中试生产的3批双佐剂口蹄疫A型、O型和亚洲Ⅰ型三价灭活疫苗在新疆的阿克苏、伊犁、昌吉等地区进行了临床试验,以进一步评估疫苗的安全性、效力和免疫持续期。结果显示,所有免疫的3 682头牛和33 240只羊（包含怀孕动物和幼畜）食欲、精神均正常,孕期动物无流产,对幼畜生长无影响,无其他不良反应,整个试验期内入试牛羊无口蹄疫发生。经200多头免疫牛6个月的定期采血,用液相阻断ELISA方法检测,显示免疫后第1~2个月内抗体滴度达到最高峰,几何均值最高A型可达1∶558、O型可达1∶332、亚洲Ⅰ型可达1∶381;随后抗体水平有所下降,在第3个月后维持在一定的滴度直至第6个月。结果表明,该疫苗安全、可靠。

To evaluate the safety,duration of the immunity and vaccine efficacy of the inactivated vaccine with trivalence for foot and mouth disease（Type A,O and Asia I）,three batches of the vaccine from the pilot plant were applied for the clinical studies in Akesu,Yili and Changji areas of Xinjiang Uygur autonomous region,respectively.The results showed that 3 682 cattle and 33 240 sheep including pregnancy animals and young animals did not manifest any side reaction with normal appetite and sanity during the trials.Foot-and-mouth disease and abortion didn＇t occur in the testing cattle and sheep.More than 200 cattle were immunized with the inactivated vaccine with trivalence for foot and mouth disease and the antibody was detected by LB-ELISA during 6 months.The antibody titer reached the peak value after 1 to 2 months of the inoculation and the highest value（geometry mean）of type A,O and Asia I was 1∶558,1∶332 and 1∶381,respectively.The antibody titer decreased with the prolonged time,but the differences of the antibody levels was not significant between 3 and 6 months.It was concluded that the vaccine was safe and reliable for the immunization of cattle and sheep.