Determination of potency of vaccines containing tetanus toxoid / Radwa Abdellah Sayed Mohamed ; Supervised Mohamed Ali Eldesouky , Nahla Shehata Kotb

Thesis (M.Sc.) - Cairo University - Faculty of Science - Department of Biochemistry

Regulatory authorities seek that quality control tests are implemented on each vaccine lot to ensure safety and effectiveness of such complex products. There has been much activity in recent years aimed at simplifying the current tests of potency - by using serological, by reducing the quantity of animals used, refining the end-point used, and by considering the possibility of using the same animals to test the potency of several antigens in serological assays. Our study endeavored to introduce the serological method for the assessment of potency of tetanus toxoid vaccines as an alternative to the challenge method in order to be implemented in the Egyptian regulatory authority that assure the quality of vaccines in Egypt, to assess the efficacy of tetanus toxoid vaccines that are used in the Egyptian immunization program which are locally produced or imported, reduce number of animals used in the potency test and also to improve safety for the laboratory technicians. Samples from four different tetanus toxoid vaccines were used to carry out the potency test of the tetanus component by using the challenge assay in mice and the serological assay in guinea pigs

Issued also as CD