Accelerated stability studies of Otto Flu Plus Vac under the influence of stress conditions

Abstract

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 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.