Evaluation of injection site reactions after intramuscular or subcutaneous injection of swine with M~+Pac~(TM) adjuvanted with a dual-action, oil-in-water adjuvant, emunade~(TM)

摘要

Schering-Plough Animal Health Corp. (SPAH) currently markets a Mycoplasma Hyopneumoniae Bacterin under the trade name M~+Pac~(TM). The product is adjuvanted with a proprietary dual adjuvant system (Emunade~(TM)) containing an oil component. Both antibody titers and cell-mediated immunity may be indicators of a protective immune response following vaccination or exposure of swine with M. hyopneumopniae. Trials have demonstrated that vaccination of swine with M~+Pac~(TM) results in higher and more prolonged antibody titers, a higher CMI response, and lower lung lesions, when compared to competitive products) In addition to this demonstrated superior efficacy, M~+Pac~(TM) has a remarkable safety record in field usage. Since the introduction of this product in 1996, only one report from the field involving possible local reactions after vaccination with M~+Pac~(TM) has been registered with SPAH. However, in this report, a competitor's mixed bacterin had been injected concomitantly in the same site, so it was not possible to ascertain the cause of the local reactions. As is standard with the use of oil adjuvants in food-producing animals, because of the possibility of prolonged injection site reactions, the current label for M~+Pac~(TM) requires a 60-day withholding period prior to marketing the animal. The objective of this study was to evaluate injection sites at early timepoints after vaccination to determine the extent and character of gross and microscopic lesions after vaccination of swine with M~+Pac~(TM).