Abstract

Replacement of the efficiency checks for diphtheria vaccines is an excessive precedence for the worldwide initiative to reduce, refine, and change animal use in vaccine testing. Diphtheria toxoid containing vaccine merchandise marketed in the US presently require efficiency trying out with the aid of the United States Public Health Service (USPHS) test, which consists of an in vivo passive safety take a look at with a diphtheria toxin challenge. Here we describe an in vitro Diphtheria Vero Cell (DVC) assay which combines the immunization method from the USPHS check and the use of a telephone primarily based neutralization assay for serological checking out of vaccine potency. The DVC assay reduces the typical wide variety of animals used in contrast to other serological efficiency assessments and eliminates the in vivo toxin task used in the US test. The DVC assay can be used to take a look at vaccine merchandise with a low or excessive diphtheria toxoid dose.