A Multicenter, Randomized Field Trial on the Efficacy and Safety of VEPURED？, A New Vaccine Against Edema Disease in Pigs

The aim of this study was to evaluate under field conditions the efficacy and safety of Vepured, a new recombinant vaccine against Edema Disease in pigs. The study was conducted on five commercial farrow-to-finish pig farms, which had historical records of clinical signs and presented F18-positive E.coli producing VT2e. The study was designed as a multicenter, randomized, placebo-controlled, blinded field trial comparing Vepured vaccine to a placebo (phosphate-buffered saline). Animals, at the age of 2-3 days, were administered intramuscularly with 1mL of Vepured (n=945) or with 1mL of phosphate-buffered saline (n=824). After product administration, animals were followed-up until slaughter. During this period, several efficacy and safety parameters were evaluated. On each farm, animals from both groups were held in the same unit and subjected to the same husbandry practices throughout the study. Clinical outbreaks of edema disease were only reported on four farms. On these farms, vaccination with Vepured resulted in a statistically significant reduction in both the mortality rate and the occurrence of clinical signs related to the disease. A statistically significantly higher mean growth performance was also reported in the vaccinated group compared to the placebo group. In the farm without clinical outbreak of edema disease differences were also observed in growth performance in favor of the vaccinated group. No systemic reactions were observed during or immediately after vaccination with Vepured. Only mild transient local reactions, and slight clinically non-relevant temperature increases were reported in some animals. The results obtained in this study demonstrate that vaccination with Vepured is safe and efficacious against naturally occurring edema disease infection