STABILIZATION OF ORAL POLIOVIRUS VACCINE INFECTIVITY TO LYOPHILIZATION

口服脊髓灰质炎病毒疫苗(OPV)迅速失去传染性和效力 除非以冷冻状态储存。这种疫苗的交付将是 通过开发不那么严格的OPV存储而大大增强 条件。世界各地的各种实验室都在试图 通过添加稳定化合物或添加稳定化合物来稳定疫苗 成功的冷冻干燥程序的开发。我们一直在寻找 开发脊髓灰质炎病毒的冷冻干燥程序。与之形成鲜明对比的是 一些病毒疫苗，脊髓灰质炎病毒的传染性在 冷冻干燥。我们评价了不同的冷冻干燥条件。 在添加各种物质的同时 冷冻干燥，试图设计出一种成功的方法 脊髓灰质炎病毒。通过D抗原的酶联免疫吸附试验来评估病毒的稳定性 并进行斑块测试以检测传染性。脂基试剂的包合物 极大地提高了病毒存活率，提高了1000倍，结果是 冷冻干燥后传染性存活率在20-40%。进一步研究 已将传染性病毒的回收率提高到50%以上 然而，温度稳定性研究表明， 冻干病毒与溶液中的病毒无显著差异。 目前的努力集中在使用程序来稳定 病毒粒子衣壳结构而不损害病毒的感染性 病毒。可切割的双功能蛋白交联剂的使用 展现出了希望。然而，氧化氢的使用似乎是一种 更简单、更容易接受的方法。因此，我们正在结束这件事 项目。

Oral poliovirus vaccine (OPV) rapidly loses infectivity and potency unless stored in a frozen state. Delivery of this vaccine would be greatly enhanced 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 lyophilization 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 1000x, resulting in 20-40% survival of infectivity after lyophilization. Further studies have raised the recovery of infectious virus to greater than 50% However, temperature stability studies have indicated that the lyophilized virus is not significantly different than virus in solution. Current efforts have focused on using procedures that stabilize the capsid architecture of the virion without impairing the infectivity of the virus. The use of cleavable bifunctional protein cross linkers has shown promise. However, the use of deuterium oxide appears to be a simpler and more acceptable approach. Therefore, we are winding up this project.