鸡新城疫-传染性支气管炎-传染性法氏囊病三联灭活疫苗安全性及效力试验

Safety and Efficacy Test to the Newcastle Disease,Infectious Bronchitis and Infectious Bursal Disease Trivalent Inactivated Vaccine

为评价以悬浮培养制备的鸡传染性法氏囊病毒(IBDV)抗原液为组份之一的鸡新城疫(ND)-传染性支气管炎(IB)-传染性法氏囊病(IBD)三联灭活疫苗的安全性及效力,实验室制备3批疫苗,按照《中国兽药典》附录对疫苗进行物理性状、无菌检验、安全及效力试验。结果显示3批次疫苗物理性状、无菌检验均合格;2倍剂量注射21日龄的SPF鸡,14 d后剖检注射部位未见炎症反应,疫苗吸收良好,说明疫苗安全;疫苗免疫SPF鸡后21 d,ND和IB血凝抑制(HI)抗体,IBD中和抗体均合格,攻毒实验证明,免疫鸡10/10保护,对照鸡5/5发病或死亡。表明以悬浮培养制备的IBDV抗原液生产的三联灭活疫苗安全有效。

The purpose of this study is to evaluate the safety and efficacy of the newcastle disease, infectious bronchitis and infectious bursa disease （suspension cultured antigen） trivalent inactivated vaccine. 3 batches of vaccine were prepared in the laboratory. The physical properties, sterility test, safety and efficacy of the vaccine were tested according to the ＂ Chinese Veterinary Pharmacopoeia＂. The results showed that the physical properties, sterile test were all qualified to 3 batches of vaccine. Safety tests showed that no inflammatory response was found at the injection site and the vaccine was absorbed 14 days after double doses vaccine were injected to the 21 day old SPF chicken. Efficacy tests show that ND HI, IB HI titer and IBD neutralizing antibody titer were all qualified to the standard 21 days after vaccination. The challenge tests showed that 10/10 were protected to the immunized chickens and 5/5 were positive to the challenge chickens which had clinical symptoms or died with specific symptoms or lesions. The trivalent inactivated newcastle disease, infectious bronchitis and infectious bursadisease （suspension cultured antigen） vaccine is safe and effective.