پديد آورندگان :
Tavajohi S نويسنده , Rastegart H نويسنده , Ostad S.N نويسنده , Rezayat S.M نويسنده , Ghahramani M. نويسنده
چكيده لاتين :
Vaccination against mumps is included in world Health Organization (WHO) program of
global immunization. Safety and efficacy of vaccines must be confirmed by control units in charge of
public health. In Iran, the secondary control on potency of vaccine has not been set up yet. We decided
to overcome this problem by developing WHO and NIBSC methods in Food and Drug Control Lab.
Nine dilutions of vaccine from 10-1 to 10-5 in 0.51oglO steps were mixed with Vero cell suspension. In
WHO n1ethod, the cell suspension was seeded in octaplicate (8 wells of each dilution) in 24-well plate
and incubated at 36°C for 10 days, during which the cells were checked for cytopathic changes
everyday and positive wells were recorded. We used 5% serum and 1 x 105 cells for the assays. The test
was repeated with six different vaccines produced in one batch. The mean potency was 10 4.475±O.134
CCIDso/vial for each ten-dose vial. For NIBSC method the dilutions of vaccine were added to
hexaplicate (6 well per dilution) in 24-wells plate. After 3 hours, the medium was removed and overlay
was added. Then the plates were incubated at 35°C for 10 days. After incubation period, the plaques
were stained with methyl violet and counted. This assay was repeated three times and the mean of
results was 5.93 10g1o PFU/dose. Results indicate that the potency of the vaccine is in acceptable range
in either method. WHO method is simple and less time consuming compared to NIBSC method.
