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Development and evaluation of alternative methods to replace animal experiments (NIH-Test) for the potency measure of vaccines against rabies
Project
Project code: BfR-ZEBET-08-1328-203
Contract period: 01.08.2007
- 31.07.2010
Purpose of research: Applied research
Rabies vaccines are usually based on cell culture derived purified and inactivated virus. In contrast to veterinary vaccine preparations, which contain aluminium hydroxide or aluminium phosphate as adjuvants, vaccines to be used in humans are usually free of adjuvants. Licensing of rabies vaccines includes the demonstration of vaccine efficacy in the target species. Moreover before release of vaccine batches, stringent quality control tests have to be performed including individual potency control to demonstrate consistency of the product. The prescribed procedure for potency testing of rabies vaccines is the National Institutes of Health (NIH) Test. This test is performed in mice and includes the clinical disease and death of non protected control animals. In addition, the test is expensive, takes a long time and has a high degree of variability.The objective of the current work is the development of in vitro testing methods to determine the potency of adjuvanted or non-adjuvanted vaccines against rabies.
Section overview
Subjects
- Animal health
Framework programme
Funding programme
Excutive institution
BfR - Centre for Documentation and Evaluation of Alternatives to Animal Experiments (BfR - ZEBET)