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Paper Information

Title: 

EVALUATION OF POTENCY OF MEASLES & RUBELLA VACCINE, USED IN IRAN, USING WHO METHOD IN CELL CULTURE

Type: SPEECH
Author(s): TAVAJOHI SH.*,RASTGAR H.,OSTAD S.N.,REZAYAT M.,ABDI KH.,GHAHRAMANI M.H.
 
 *FOOD & DRUG CONTROL LAB (F.D.C.L), MINISTRY OF HEALTH & MEDICAL EDUCATION
 
Name of Seminar: IRANIAN CONGRESS OF TOXICOLOGY
Type of Seminar:  CONGRESS
Sponsor:  SOCIETY OF TOXICOLOGY
Date:  2004Volume 8
 
 
Abstract: 

Measles and Rubella viruses have been a major cause of death and teratogenisity in many countries and immunization against them, by vaccination, is in WHO program of global immunization. A suitable vaccine should create maximum immune response agonist the pathogen and be safe. Thus after production, the vaccines must be analyzed and controlled by the producer and confirm by control units of governmental health organization. In Iran, the secondary control on potency of vaccine has not been set up yet. Therefore we decided to develop this method in F.D.C.L. to solve this problem.
The vaccines were obtained from Razi Institute. For each vaccine nine dilutions (from 10-1 to 10-5) in 0.5Log interval was prepared and each dilution and mixed with the Vero cell suspension for Measles vaccine and RK-13 cell suspension for Rubella vaccine and the cell suspension was seeded in octaplicate (8 wells of each dilution) in 24-well plate. For Measles, the Vero cells were incubated at 36ºC for 10 days and for Rubella, the plates were incubation at 32ºC for 12 days, during which the cells were checked for cytopatic changes everyday and positive wells recorded. To set up the assay, we tested four different cell seeding (2x105-5x104) and four different concentration of serum (2.5-10%), since they may affect the cytopatic effect of the vaccine. Based on our results, we used 5% serum and 1x105 cells for the assays. The test was repeated with six different vaccines produced in one batch. The mean potency for Measles was 104.32 ± 0.24 CCID50/vial for each ten-dose vial. The potency was measured as 104.49±0.15 CCID50/vial for Rubella vaccine in a ten-dose vaccine. In this study, we have set up the WHO method to evaluate Measles and Rubella vaccine in FDCL. Furthermore, our results indicate that the potency of vaccines used in this study is in the acceptable range of WHO and the mean potency we have obtained is equivalent to the titer reported by Razi Institute

 
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