The evaluation of humane endpoints in pertussis vaccine potency testing
Evaluatie van de humane eindpunten bij kinkhoest controle testen
Steen BVL , Hendriksen CFM , Visser J , Cussler K , Morton D , Streijer F
RIVM Report 623860007
One particular approach to reduce pain and suffering in laboratory animals is the introduction of humane endpoints. Vaccine potency tests, as specified in the pharmacopoeias, are frequently based on an immunisation-challenge procedure in rodents or in the target species, using survival of the animals as a parameter for the estimation of the batch potency. An example of a such a lethal challenge procedure is the pertussis vaccine potency test. We have evaluated the use of clinical signs and such patho-physiological changes as decrease of body temperature and body weight as potential alternatives to death as the endpoint of this test. From the results of the study we conclude that loss of muscular co-ordination of the animal and a decrease in body temperature below 34.5 degrees Celsius could be used as an endpoint. A decrease in body weight, although the first sign of the disease, appeared to be a poor predictor for lethality.