Results of an inquiry on potency testing of rabies vaccine by the NIH test: suggestions for further improvement

Designing of Immuno-capture ELISA assay kit for rabies vaccine potency

Background: Potency evaluation of rabies vaccine is a cheap, fast, high precision and consistent with ethical values is critical, so researchers have modified a variety of methods such as: National Institute of Health (NIH) method, Single Radial Immunodiffusion (SRID) and so on. The purpose of the present study was to replace an in vitro method consistent with medical ethics criteria instead of...

Antigenic variation between rabies virus strains and its relevance in vaccine production and potency testing

An electrochemiluminescence assay for analysis of rabies virus glycoprotein content in rabies vaccines.

Vaccine potency testing is necessary to evaluate the immunogenicity of inactivated rabies virus (RABV) vaccine preparations before human or veterinary application. Currently, the NIH test is recommended by the WHO expert committee to evaluate RABV vaccine potency. However, numerous disadvantages are inherent concerning cost, number of animals and biosafety requirements. As such, several in vitr...

Rabies Vaccines for Human Use: Potency Testing Without Mouse Challenge?

215 Rabies vaccines for human use currently are tested for potency by a mouse challenge assay. this test was developed by the National Institutes of Health (NIH) and is therefore referred to as the NIH test. Its origins go back to the 1950’s, well before good manufacturing practice (GMP) was established. the NIH test soon was recognized to be highly variable, to consume a large number of animal...

Report on the international workshop on alternative methods for human and veterinary rabies vaccine testing: state of the science and planning the way forward.

Potency testing of most human and veterinary rabies vaccines requires vaccination of mice followed by a challenge test using an intracerebral injection of live rabies virus. NICEATM, ICCVAM, and their international partners organized a workshop to review the availability and validation status of alternative methods that might reduce, refine, or replace the use of animals for rabies vaccine pote...