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| 5种塞内卡病毒灭活疫苗佐剂的比较研究 |
| 李晓艳,齐志涛,王秉昆,赵丽霞,温学平,李超,方建国、高艳华、杨青春,贺瑶,宋庆庆,陈坚 |
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| (金宇保灵生物药品有限公司) |
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| 摘要: |
| 为研究对比自主研发佐剂与Seppic206佐剂配制的塞内卡病毒疫苗的品质,分别用4种自主研发佐剂及Seppic206佐剂配制塞内卡病毒灭活疫苗,检测疫苗的理化性质、安全性及免疫效力,并对检测结果进行对比分析。结果显示,Seppic206佐剂疫苗黏度为43.02,自主研发佐剂疫苗黏度均在27.88以下,其他理化性质无差异；5批疫苗安全性检验均未见明显异常；5批疫苗免疫动物后均可诱导机体产生中和抗体,于二免后14天,抗体滴度在211以上,4批自主研发佐剂疫苗免疫组抗体滴度水平高于Seppic206佐剂疫苗约1个滴度,攻毒保护结果均在4/5以上,2批自主研发佐剂疫苗免疫组保护率可达5/5。结果表明,用4种自主研发佐剂制备的塞内卡病毒灭活疫苗与Seppic206佐剂制备的塞内卡病毒灭活疫苗品质无差异,甚至高于后者。 |
| 关键词: 疫苗佐剂 塞内卡病毒 灭活疫苗 安全检验 效力检验 |
| DOI： |
| 投稿时间：2021-10-11修订日期：2022-01-06 |
| 基金项目: |
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| Comparison on the Quality of Seneca Virus Inactivated Vaccine Prepared by 5 Adjuvants |
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| (Jinyu Baoling Biopharmaceutical Co., Ltd.) |
| Abstract: |
| In order to compare the quality of Seneca virus vaccine prepared by independently developed adjuvant and seppic206 adjuvant, four kinds of independently developed adjuvant and Seppic206 adjuvant were used to prepare Seneca virus inactivated vaccine respectively. The results showed that the viscosity of independently developed adjuvant (27.88) is lower than viscosity of seppic206 adjuvant (43.02), and there was no difference in physical and chemical properties. No obvious abnormality was found in the safety test of 5 batches of vaccines. it can induce the body to produce neutralizing antibody that all 5 batch of vaccines immunized to animals. 14 days after second immunization, over 211, the antibody concentration in 4 batch of independent research and development of adjuvant vaccine group level higher than the antibody concentration Seppic206 adjuvant vaccine about 1 degree, tapping poison protection results in more than 4/5, 2 batch of independent research and development of adjuvant vaccine group which can reach 5/5. In conclusion, the quality of the inactivated Seneca virus vaccine prepared with 4 independently developed adjuvants had no difference with that of the inactivated Seneca virus vaccine prepared with Seppic206 adjuvant, or even higher than speeic206 adjuvant. |
| Key words: Adjuvant Seneca virus inactivated vaccine safety test efficacy test |
