Authors : Aqsa Afzal, Muhammad Danish Mehmood, Huma Anwar Ul-Haq, Muhammad Ismail
DOI : 10.18231/j.ijmr.2019.062
Volume : 6
Issue : 4
Year : 2019
Page No : 284-293
Real time and accelerated stability testing plays a vital role in determining the integrity of a vaccine during
shelf life under controlled environmental storage conditions. Currently, vaccines have been manufactured
utilizing both conventional and allied technology however, conservation of immunogen strength and
stability during transportation and storage under specified thermal conditions are the pre requisite for its in
vivo potency. Therefore, current study was undertaken to evaluate the potency of such vaccines following
manufacturer recommendation under the influence of artificially induced stress conditions. Total of 96,
company retained reference samples of Otto Flu Plus vaccine were analyzed under real time and accelerated
stability testing for its physiochemical properties and serological potency. In an attempt, vaccine samples
were kept at 2-8?C for 15 months. A second group of samples were analyzed when stored at 4 to 20?C
for 6 months. Total of 30 broilers were injected with vaccine at 25th day of age. Seroconversion was
evaluated by heamagglutination inhibition assay at 28-day post vaccination. It was revealed that Otto Flu
Plus vaccine stored for 15 months at 2-8?C showed optimum results (p>0.05) as compared to the vaccine
stored at 20?C for 6 months (p<0>
It is concluded that Otto Flu Plus vaccine stored at 2-8?C showed intact emulsion integrity and induced
protective antibody titer for 15 months as compare to the vaccine stored at 20?C for 6 months. The results
suggest that the respective vaccine is safe to use at 2-8?C for 15 months without any deleterious effect on
immunity.
Keywords: Real time stability, Accelerated stability, Heamagglutination Inhibition assay, Immunoprophylaxis.