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[用于预防阿根廷出血热的Candid#1疫苗的稳定性]

[Stability of Candid#1 vaccine to prevent Argentine Hemorrhagic Fever].

作者信息

Saavedra María Del Carmen, Riera Laura M, Bottale Alejandro J, Mariani Mauricio A, Maiza Andrea S, Ambrosio Ana María

机构信息

Instituto Nacional de Enfermedades Virales Humanas Dr. Julio I. Maiztegui (INEVH-ANLIS), Pergamino, Buenos Aires, Argentina. E-mail:

Instituto Nacional de Enfermedades Virales Humanas Dr. Julio I. Maiztegui (INEVH-ANLIS), Pergamino, Buenos Aires, Argentina.

出版信息

Medicina (B Aires). 2017;77(5):353-357.

Abstract

Candid#1 is the first live attenuated vaccine produced and registered in Argentina. Produced since 2003 at the INEVH to prevent Argentine hemorrhagic fever, it is obtained by harvesting supernatants of diploid cells infected with an attenuated strain of Junin virus and subsequent lyophilization. The stability of this vaccine is crucial to ensure its effectiveness. This study was aimed to evaluate the stability of Candid#1 by exposing it to different time and temperature conditions. Three vaccine batches produced in 2003 were analysed according to the following storage scheme: (a) reconstituted vaccine at 2 °C to 8 °C for 8 days; (b) lyophilized vaccine at 2 °C to 8 °C for 6 months; (c) lyophilized vaccine at -18 °C to -20 °C for 10 years. The potency was assessed in Vero cell monolayers under agar. The results were: (a) reconstituted vaccine was stable between 2 °C and 8 °C for 8 days, (b) lyophilized vaccine was stable between 2 °C and 8 °C for 2 months, and (c) lyophilized vaccine was stable 9 years between -18 °C and -20 °C, keeping all its properties. These results allowed us to establish the following storage conditions and expiration times for Candid#1: (a) reconstituted: 12 hours between 2 °C and 8 °C, (b) lyophilized: 30 days between 2 °C and 8 °C and (c) lyophilized: 9 years between -18 °C and -20 °C. Based on our results, favorable changes were made in the conditions of transport, storage and distribution of the vaccine. Domestic freezers in strategically located centers were installed, allowing the preservation of vaccine stocks for distribution to secondary vaccination centers.

摘要

坎迪德#1是阿根廷生产并注册的第一种减毒活疫苗。自2003年以来在国家病毒学和卫生研究所(INEVH)生产,用于预防阿根廷出血热,它是通过收集感染胡宁病毒减毒株的二倍体细胞的上清液并随后冻干获得的。这种疫苗的稳定性对于确保其有效性至关重要。本研究旨在通过将坎迪德#1暴露于不同的时间和温度条件来评估其稳定性。根据以下储存方案分析了2003年生产的三批疫苗:(a) 重组疫苗在2℃至8℃下保存8天;(b) 冻干疫苗在2℃至8℃下保存6个月;(c) 冻干疫苗在-18℃至-20℃下保存10年。在琼脂覆盖的Vero细胞单层中评估效力。结果为:(a) 重组疫苗在2℃至8℃下8天内稳定,(b) 冻干疫苗在2℃至8℃下2个月内稳定,(c) 冻干疫苗在-18℃至-20℃下9年内稳定,且所有特性保持不变。这些结果使我们能够确定坎迪德#1的以下储存条件和有效期:(a) 重组:在2℃至8℃下12小时,(b) 冻干:在2℃至8℃下30天,(c) 冻干:在-18℃至-20℃下9年。基于我们的结果,对疫苗的运输、储存和分发条件进行了有利的改变。在战略位置的中心安装了家用冰柜,以便保存疫苗库存,用于分发给二级疫苗接种中心。

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