冻干甲型肝炎减毒活疫苗的研制

［摘 要］目的 研制冻干甲肝减毒活疫苗，提高疫苗的稳定性，便于保存及运输，保证疫苗的接种效果。方法 采用CA－9冻干保护剂，制备冻干疫苗，疫苗液与保护剂之比为3．5∶1。结果 冻干甲肝减毒活疫苗具有与液体疫苗相同的安全性及免疫原性。在2～8℃保存的有效期较液体疫苗的3～5个月提高到18个月。在室温和37℃保存的稳定性也明显提高。结论 冻干甲肝疫苗的稳定性良好，无需低温保存、冷链运输，便于甲肝疫苗的大规模推广应用。

Preparation of Freeze-dried Live Attenuated Hepatitis A Vaccine

Abstract] Objective To prepare freeze- dried live attenuated hepatitis A vaccine and study on the stability of it. Methods Live attenuated hepatitis A vaccine was freeze - dried using CA - 9 as protective agent. The ratio of vaccine to protective agent was 3.5: 1. Results The safety and immunogenicity of the freeze - dried vaccine were identical to those of liquid vaccine. Compared with that of liquid vaccine, the validity period of freeze - dried vaccine at 2 - S癈 increased from 3-5 to 18 months. The stability of it at room temperature and 37 癈 were also improved significantly. Conclusion The freeze - dried HA vaccine is stable and needs no storage at low temperature or transport by cold chain. It is suitable for large - scale application.