In a blinded, randomized, placebo-controlled, and commingled (placebo and vaccinates) laboratory study, the RECOMBITEK 4 Lepto vaccine provided significant protection against both leptospirosis* and urinary shedding of the bacterium (leptospiruria).
Despite most vaccinates being commingled with control dogs actively shedding spirochetes in their urine, 100% of vaccinates were protected from leptospirosis* for serovars Canicola, Icterohaemorrhagiae, and Grippotyphosa, and 95% of the vaccinates were protected from leptospirosis* for serovar Pomona.
Leptospiruria was prevented in 100% of the serovar Canicola and Grippotyphosa vaccinates. Leptospiruria was prevented in 89% and 95% of the vaccinates for serovars Icterohaemorrhagiae and Pomona respectively.
*Leptospirosis was defined as having at least 1 positive urine sample for leptospiruria and a positive renal histopathology score; or, in the absence of renal pathology, multiple positive urine samples for leptospiruria–these criteria for leptospirosis definition were evaluated and approved by the United States Department of Agriculture prior to study onset.