RESEARCH AND DEVELOPMENT OF A PROCEDURE TO TEST THE EFFICACY OF ACELLULAR PERTUSSIS BY CHALLENGE METHOD IN MICE AT NATIONAL INSTITUTE FOR CONTROL OF VACCINES AND BIOLOGICALS

Abstract

Background/Purpose: In quality control of pertussis vaccines, efficacy testing is an important test. Acellular pertussis vaccine is preferred because of its safety. However, in Vietnam, there is still no specific testing procedure for this test. So the research team proceeded to develop this test procedure using the challenge method on ICR mice.

Methods: The study applied the procedure to the potency test of pertussis acellular vaccine by the challenge method on ICR mice. The potency tests were repeated 5 independent times and were performed in parallel with the international reference standard vaccine (JNIH-3), known value potency units (34 IU/vial), and the samples pertussis acellular vaccine.

Results: Research results show that the average potency value of acellular pertussis vaccine through 05 trials is (76.72 IU/ml), and the results value of the trials is within ±2SD, which meets the requirements of WHO TRS No.979 and Vietnam Pharmacopoeia version V for pertussis acellular vaccine.

Conclusion: Developed a process to test the effectiveness of acellular pertussis vaccine by challenge method on mice ICR, acellular pertussis vaccine meeting WHO standards, and Vietnam Pharmacopoeia V.