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冻干人用狂犬病疫苗具有良好的热稳定性和免疫原性。

Rabies vaccine preserved by vaporization is thermostable and immunogenic.

作者信息

Smith Todd G, Siirin Marina, Wu Xianfu, Hanlon Cathleen A, Bronshtein Victor

机构信息

Poxvirus and Rabies Branch, Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, USA.

Universal Stabilization Technologies Inc., 4050 L Sorrento Valley Boulevard, San Diego, CA 92121, USA.

出版信息

Vaccine. 2015 May 5;33(19):2203-2206. doi: 10.1016/j.vaccine.2015.03.025. Epub 2015 Mar 23.

Abstract

A rabies vaccine that is thermostable over a range of ambient environmental temperatures would be highly advantageous, especially for tropical regions with challenging cold-chain storage where canine rabies remains enzootic resulting in preventable human mortality. Live attenuated rabies virus (RABV) strain ERAG333 (R333E) was preserved by vaporization (PBV) in a dry, stable foam. RABV stabilized using this process remains viable for at least 23 months at 22°C, 15 months at 37°C, and 3h at 80°C. An antigen capture assay revealed RABV PBV inactivated by irradiation contained similar levels of antigen as a commercial vaccine. Viability and antigen capture testing confirmed that the PBV process stabilized RABV with no significant loss in titer or antigen content. Live attenuated and inactivated RABV PBV both effectively induced RABV neutralizing antibodies and protected mice from peripheral RABV challenge. These results demonstrate that PBV is an efficient method for RABV stabilization.

摘要

一种在一定环境温度范围内具有热稳定性的狂犬病疫苗将具有很大优势,特别是对于冷链储存具有挑战性的热带地区,在这些地区犬类狂犬病呈地方流行,导致可预防的人类死亡。减毒活狂犬病病毒(RABV)毒株ERAG333(R333E)通过蒸发冻干法(PBV)保存在干燥、稳定的泡沫中。用这种方法稳定化的RABV在22°C下至少可存活23个月,在37°C下可存活15个月,在80°C下可存活3小时。抗原捕获试验显示,经辐照灭活的RABV PBV所含抗原水平与商业疫苗相似。活力和抗原捕获测试证实,PBV工艺可稳定RABV,且效价或抗原含量无显著损失。减毒活RABV PBV和灭活RABV PBV均能有效诱导RABV中和抗体,并保护小鼠免受外周RABV攻击。这些结果表明,PBV是一种稳定RABV的有效方法。

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