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

A versatile in vitro ELISA test for quantification and quality testing of infectious, inactivated and formulated rabies virus used in veterinary monovalent or combination vaccine

“…In contrast, soluble monomeric glycoprotein G could not be quantified. As such, this ELISA complies with the requirements of the international workshop on alternative methods for human and veterinary rabies vaccine stating that the potency of rabies vaccines must be measured with a quantitative method specific for the virus-associated conformationally intact G protein [2].…”

“…All recommendations of the international workshop on alternative methods for human and veterinary rabies vaccine were fulfilled [2]. Because it targets well conformed non-linear epitopes of glycoprotein G involved in the induction of potent neutralizing antibodies, this ELISA could be used for in vitro quality control along process and as a potency test, avoiding the use of mice.…”

“…The ability to quantify an antigen in a formulated vaccine is often a limit to the implementation of in vitro testing. Another advantage is the precision of the ELISA test while the Ph.Eur challenge and NIH tests are known to be highly variable [2]. This ELISA would therefore be a valuable potency test.…”

“…An alternative in vitro test, faster, less variable, more consistent and allowing the reduction of lab animal use in compliance with the "3R's" (Reduce, Replace, Refine) should be implemented to replace the in vivo potency test [2,3].…”

Vaccine Analysis: Strategies, Principles, and Control

“…For example, the global efforts between manufacturers of rabies vaccines for human and veterinary use, regulatory agencies, National Institutes of Health (NIH), and several organizations to replace the in vivo potency test (called "NIH test") used to release these vaccines by in vitro alternative methods consistent with 3Rs principles of animal testing (Replacement, Reduction and Refinement) (Stokes et al 2012). Some ongoing or recent approaches are promising.…”