title: Report on the international workshop on alternative methods for human and veterinary rabies vaccine testing: state of the science and planning the way forward.
abstract: 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 potency testing, and to identify research and development efforts to further advance alternative methods. Workshop participants agreed that general anesthesia should be used for intracerebral virus injections and that humane endpoints should be used routinely as the basis for euthanizing animals when conducting the mouse rabies challenge test. Workshop participants recommended as a near-term priority replacement of the mouse challenge with a test validated to ensure potency, such as the mouse antibody serum neutralization test 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 human and non-adjuvanted 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.
authors.affiliation: National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, Division of the National Toxicology Program, National Institute of Environmental Health Sciences, National Institutes of Health, P.O. Box 12233, MD: K2-16, Research Triangle Park, NC 27709, USA. stokes@niehs.nih.gov
authors.forename: William
authors.initials: W
authors.lastname: Stokes
authors.forename: Richard
authors.initials: R
authors.lastname: McFarland
authors.forename: Jodie
authors.initials: J
authors.lastname: Kulpa-Eddy
authors.forename: Donna
authors.initials: D
authors.lastname: Gatewood
authors.forename: Robin
authors.initials: R
authors.lastname: Levis
authors.forename: Marlies
authors.initials: M
authors.lastname: Halder
authors.forename: Gayle
authors.initials: G
authors.lastname: Pulle
authors.forename: Hajime
authors.initials: H
authors.lastname: Kojima
authors.forename: Warren
authors.initials: W
authors.lastname: Casey
authors.forename: Alexander
authors.initials: A
authors.lastname: Gaydamaka
authors.forename: Timothy
authors.initials: T
authors.lastname: Miller
authors.forename: Karen
authors.initials: K
authors.lastname: Brown
authors.forename: Charles
authors.initials: C
authors.lastname: Lewis
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Chapsal
authors.forename: Lukas
authors.initials: L
authors.lastname: Bruckner
authors.forename: Sunil
authors.initials: S
authors.lastname: Gairola
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Kamphuis
authors.forename: Charles E
authors.initials: CE
authors.lastname: Rupprecht
authors.forename: Peter
authors.initials: P
authors.lastname: Wunderli
authors.forename: Lorraine
authors.initials: L
authors.lastname: McElhinney
authors.forename: Fabrizio
authors.initials: F
authors.lastname: De Mattia
authors.forename: Koichiro
authors.initials: K
authors.lastname: Gamoh
authors.forename: Richard
authors.initials: R
authors.lastname: Hill
authors.forename: David
authors.initials: D
authors.lastname: Reed
authors.forename: Vivian
authors.initials: V
authors.lastname: Doelling
authors.forename: Nelson
authors.initials: N
authors.lastname: Johnson
authors.forename: David
authors.initials: D
authors.lastname: Allen
authors.forename: Lori
authors.initials: L
authors.lastname: Rinckel
authors.forename: Brett
authors.initials: B
authors.lastname: Jones
mesh_terms: D000826:Animal Testing Alternatives / Q000379:methods / Q000458:organization & administration; D000818:Animals; D004353:Drug Evaluation, Preclinical / Q000379:methods* / Q000639:trends*; D004493:Education / Q000458:organization & administration; D004520:Education, Veterinary / Q000379:methods; D006285:Health Planning / Q000639:trends; D006801:Humans; D007391:International Cooperation; D051379:Mice; D011818:Rabies / Q000276:immunology / Q000662:veterinary; D011819:Rabies Vaccines / Q000494:pharmacology / Q000592:standards / Q000627:therapeutic use; D012106:Research / Q000639:trends; D058028:Research Report; D012586:Science / Q000639:trends; D014611:Vaccination / Q000379:methods / Q000662:veterinary
chemical_list: D011819:Rabies Vaccines