Development of a Foot-and-mouth Disease Vaccine Potency Test without Conducting Animal Challenge Experiment
نویسندگان
چکیده
Introduction Vaccine manufacturers evaluate the efficiency of their vaccine according to the method which is defined in the European Pharmacopoeia. Regarding foot-and-mouth disease (FMD) vaccine there are some difficulties to find animals for potency tests in the countries like Turkey where FMD is endemic and vaccine campaigns are carried out. In addition, potency tests must be carried out in containments having high biosecurity levels. There are many publications indicating a correlation between protection from virus challenge and neutralizing antibody response. However, up to now, none of the suggested method has been found valid. Materials and methods An analysis was made of data from potency tests on four batches O1 Manisa and two batches of Asia-1 Tur 73 monovalent oil adjuvanted foot-and-mouth disease vaccine. Regression were calculated for the relation of protection from virus challenge versus antigenic load (Log 146S) and neutralizing antibody response (Log SN50), versus only Log 146S, versus only Log SN50. Results For the relation of protection from virus challenge versus Log 146S and Log SN50, R square was determined as 0,809 for O1 Manisa vaccines, 0,866 for Asia-1 Tur 73 vaccines. In addition, the amount of required antigen for % 50 protection in O1 Manisa and Asia-1 Tur 73 vaccines was found 1,15 μg and 0,75 μg respectively. Conclusion We have shown that Log SN50 and Log 146S can give good correlation with protection from virus challenge and can be used as an indirect indicator of potency.
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