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. The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), and their international partners organized an international workshop to review the availability and validation status of alternative methods that might reduce, refine, or replace the use of animals for rabies vaccine potency testing, and to identify priority research and development efforts necessary to further advance alternative methods. Workshop participants agreed that rabies vaccine potency testing using the mouse challenge test should use general anesthesia for intracerebral virus injections, and that humane endpoints should be used routinely as the basis for euthanizing animals to minimize pain and distress. Workshop participants recommended that a near term priority should be to replace the mouse challenge with a test validated to ensure potency, such as the mouse antibody serum neutralization test (SNT) for adjuvanted veterinary rabies vaccines for which an international collaborative study was recently completed. The workshop recommended that an in vitro antigen quantification test should be a high priority for product-specific validation of non-adjuvanted human and veterinary rabies vaccines. Finally, workshop participants recommended greater international cooperation to expedite development, validation, regulatory acceptance, and implementation of alternative test methods for rabies vaccine potency testing.

STOKES William;  MCFARLAND Richard;  KULPA-EDDY Jodie;  GATEWOOD D.;  LEVIS Robin;  HALDER Maria;  PULLE Gayle;  KOJIMA H;  CASEY Warren;  GAYDAMAKA Alexander;  MILLER Timothy;  BROWN Karen;  LEWIS Charles;  CHAPSAL Jean-Michel;  BRUCKNER Lukas;  GAIROLA Sunil;  KAMPHUIS Elisabeth;  RUPPRECHT Charles E.;  WUNDERLI Peter;  MCELHINNEY Lorraine;  DE MATTIA Fabrizio;  GAMOH Kochiro;  HILL Richard;  REED David;  DOELLING Vivian;  JOHNSON Nelson;  ALLEN David;  RINCKEL Lori;  JONES Brett; 

2012-12-14

ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD

JRC72759

1045-1056,   

https://publications.jrc.ec.europa.eu/repository/handle/JRC72759,   

10.1016/j.biologicals.2012.07.005,