VALIDATION OF POTENCY TEST OF MUMPS COMPONENT IN TRIVALENT VACCINE MEASLES - MUMPS - RUBELLA (MMRII) BY CCID50 METHOD
DOI:
https://doi.org/10.56086/jcvb.v4i1.141Keywords:
Công hiệu, vắc xin MMR, quai bị, phương pháp CCID50Abstract
Mumps is one of three common infectious diseases (measles, mumps, rubella) in both children and aldult that causes by virus. Mumps is spread widely in crowded community by close interaction with patient. Therefore, vaccination is proactive preventive measures to avoid having mumps or pandemic and the validation of efficiency of mumps component in trivalent measles- mumps- rubella vaccine is very important before market distribution. CCID50 method was applied in potency test for mumps component in MMRII vaccine (MSD, USA). It is a standard method that has used in many other live, attenuated vaccines, therefore, Department of Quality control of viral vaccines focus only on accurancy, precision, robustness and specificity indicators in validation of potency test. The result shows that potency value of mumps component was reached to the criteria for accurancy indicator (the average potency value of mumps reference standard was in the range of ± 0,5 log CCID50 on label), for intermediate precision indicator (the average potency value of mumps sample was 5,28 log CCID50 with CV ≤ 25%) and for robustness (no significant difference from 2 groups) and specificity indicator (the ability of virus infected cell decreasingly because it was neutralized with specific antiserum). Hence, procedure of potency test for mumps component in trivalent vaccine MMRII by CCID50 method is suitable with condition, chemicals and facility and can be applied for routine potency test in National Institute for Control of Vaccines and Biologicals
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