STABILIZATION OF ORAL POLIOVIRUS VACCINE INFECTIVITY TO LYOPHILIZATION

口服脊髓灰质炎病毒疫苗冻干感染性的稳定

• 批准号: 3770310
• 负责人: R E LUNDQUIST
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3770310
• 关键词: attenuated microorganism; capsid; chemical stability; enzyme linked immunosorbent assay; lyophilization; method development; oral administration; plaque assay; poliomyelitis vaccine; poliovirus; reagent /indicator; thermostability; virion; virulence; virus antigen

Oral poliovirus vaccine (OPV) rapidly loses infectivity and potency unless stored in a frozen state. Delivery of this vaccine would be greatly enhance by the development of less stringent OPV storage conditions. Various laboratories throughout the world are attempting to stabilize the vaccine either by the addition of stabilizing compounds or the development of successful lyophilization procedures. We have sought to develop a lyophilization procedure for poliovirus. In contrast to some viral vaccines, poliovirus infectivity is severely diminished after lyophilization. We have evaluated different lyophilizatio conditions in conjunction with the addition of various substances prior to lyophilization in an attempt to devise a successful approach for poliovirus Viral stability is assessed by an ELISA test for D-antigen and a plaque assay for infectivity. Inclusion of a lipid based reagent dramatically increases virus survival, by a factor of 10/3, resulting in 20-40% survival of infectivity after lyophilization. Further studies have raised the recovery of infectious virus to greater tha 50% However, temperature stability studies have indicated that the lyophilized virus is not significantly different than virus in solution. Our current efforts are focused on improving the temperature stability of the lyophilized virus by using procedures that stabilize the capsid architecture of the virion without impairing the effectiveness of the vaccine. Successful stabilization of OPV to less stringent storage conditions would facilitate vaccine distribution, particularly in less developed areas, and promote the global eradication of poliomyelitis.

口服脊髓灰质炎病毒疫苗（OPV）迅速失去感染性和效力，除非 以冷冻状态保存。这种疫苗的运送将大大提高 通过开发不太严格的OPV储存条件。 各种 世界各地的实验室正在试图稳定疫苗 或者通过添加稳定化合物，或者通过开发 成功的冻干程序。 我们已经寻求开发脊髓灰质炎病毒的冻干程序。 在 与一些病毒疫苗相比，脊髓灰质炎病毒的传染性是严重的， 冻干后减少。 我们已经评估了不同的冻干方法， 条件结合添加各种物质之前， 冷冻干燥，试图设计一种成功的脊髓灰质炎病毒 通过ELISA检测D抗原和空斑来评估病毒稳定性 感染性测定。 包含基于脂质的试剂， 增加病毒存活率，增加10/3倍，导致20-40%的存活率 冷冻干燥后的感染性。 进一步的研究将传染性病毒的回收率提高到大于 然而，温度稳定性研究表明， 冻干的病毒与溶液中的病毒没有显著不同。 我们目前的努力集中在提高的温度稳定性， 通过使用稳定衣壳的程序， 病毒体的结构，而不损害 疫苗 成功地将口服脊髓灰质炎疫苗稳定在不太严格的储存条件下， 促进疫苗分发，特别是在欠发达地区， 促进在全球根除小儿麻痹症。