Evaluation of the thermal stability of a novel strain of live-attenuated mumps vaccine (RS-12 strain) lyophilized in different stabilizers.
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.
Human Viral Vaccines Department, Razi Vaccine and Serum Research Institute, Karaj, Iran.
Razieh Kamali
RK
Jamil
Human Viral Vaccines Department, Razi Vaccine and Serum Research Institute, Karaj, Iran. Electronic address: taqavian@razi.tums.ac.ir.
Mohammad
M
Taqavian
Human Viral Vaccines Department, Razi Vaccine and Serum Research Institute, Karaj, Iran.
Zohreh-Azita
ZA
Sadigh
Human Viral Vaccines Department, Razi Vaccine and Serum Research Institute, Karaj, Iran.
Mohammad-Kazem
MK
Shahkarami
Human Viral Vaccines Department, Razi Vaccine and Serum Research Institute, Karaj, Iran.
Fatemeh
F
Esna-Ashari
Virology Department, Tehran University of Medical Sciences, Tehran, Iran.
Rasool
R
Hamkar
Quality Control Department, Pasteur Institute of Iran, Tehran, Iran.
Seyedeh-Marzieh
SM
Hosseini
Human Viral Vaccines Department, Razi Vaccine and Serum Research Institute, Karaj, Iran.
Alireza
A
Hatami
D000818:Animals; D002522:Chlorocebus aethiops; D003451:Cryoprotective Agents / Q000494:pharmacology*; D004355:Drug Stability; D005079:Excipients / Q000494:pharmacology; D005612:Freeze Drying / Q000379:methods*; D050296:Microbial Viability / Q000528:radiation effects*; D009108:Mumps Vaccine / Q000528:radiation effects*; D009109:Mumps virus / Q000528:radiation effects*; D013696:Temperature; D014709:Vero Cells; D019562:Viral Load
D003451:Cryoprotective Agents; D005079:Excipients; D009108:Mumps Vaccine
CCID(50); Live-attenuated; Mumps; Stabilizer; Thermostability; Vaccine