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J Virol Methods ; 199: 35-8, 2014 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-24462846

RESUMEN

The stability of live-attenuated viral vaccines is important for immunization efficacy. Here, the thermostabilities of lyophilized live-attenuated mumps vaccine formulations in two different stabilizers, a trehalose dihydrate-based stabilizer and a stabilizer containing sucrose, human serum albumin and sorbitol were investigated using accelerated stability tests at 4°C, 25°C and 37°C at time points between 4h (every 4h for the first 24h) and 1 week. Even under the harshest storage conditions of 37°C for 1 week, the 50% cell culture infective dose (CCID50) determined from titrations in Vero cells dropped by less than 10-fold using each stabilizer formulation and thus complied with the World Health Organization's requirements for the potency of live-attenuated mumps vaccines. However, as the half-life of the RS-12 strain mumps virus infectivity was lengthened substantially at elevated temperatures using the trehalose dihydrate (TD)-based stabilizer, this stabilizer is recommended for vaccine use.


Asunto(s)
Crioprotectores/farmacología , Liofilización/métodos , Viabilidad Microbiana/efectos de la radiación , Vacuna contra la Parotiditis/efectos de la radiación , Virus de la Parotiditis/efectos de la radiación , Animales , Chlorocebus aethiops , Estabilidad de Medicamentos , Excipientes/farmacología , Temperatura , Células Vero , Carga Viral
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