Set up the Potency test (challenge test) for pertussis suspension or DTP vaccine.
2009
Khafri, Abu Al-Fazl | Ja`fari, Mahdi | Tuhidi, Bizhan | Baghban Hamedi, Mohammad
Whouping couph is very contagious acute respiratory infections that produce by Bordettella Pertussis. This disease was limited by world wide vaccination (whole cell and a cellular vaccine) but this infection is remained. We must control all of our vaccine with Quality control test such as safety ¡ sterility ¡ physicochemical ¡ ... and Potency test (as an important control test). The first pertussis vaccine was produced in1930 but the first Potency test was set up by Kendrick (in this test immunized mouse challenge with pathogenic strain of Bordettella Pertussis 18323). Because of that in our country did not set up this potency test (as a necessary recommended quality control test by WHO for pertussis vaccine) for at least 30 years, we try to set up it in razi Institute. In this study we after of set up the IC injection (with automatic Hamilton device) , find a good and pathogenic strain for challenge, LD50 test , immunized the mice with standard and test vaccine and then evaluated the Potency of test vaccine with compare of the lived mice 14 days after challenge day. This test performed for 3 different batch of Razi DTP vaccine (two times) that all of result was above of standard potency limit (4 IU/dose). Therefore we can say that this test set up in Razi institute and we can do it routinely for Razi vaccine and import vaccine.
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