In contrast to the Control and Glucantime groups, none of the dogs in the two vaccine treatment groups died of CVL during the first 6 months (Fig. 1). All 15 dogs in the Vaccine group showed initial improvement at this same evaluation point (Table 2; three additional dogs that died of other causes – cardiac infarction, canine distemper, and intoxication – were censored). Selleckchem ABT-199 Similarly, 80% (12 out of 15) of Glucantime dogs and 92% (12 out of 13) of Vaccine + Glucantime dogs showed initial improvement (Table 2). During this initial 6-month period, the survival

curves of the immunotherapy and the immuno-chemotherapy groups (Fig. 1) were significantly different from the Control group (P = 0.003 and P = 0.010 for immunotherapy and immuno-chemotherapy, respectively, by the logrank test), while curves for the chemotherapy alone and Control groups were not significantly different Selleckchem Antidiabetic Compound Library (P = 0.081). At the 36-month follow-up examination, 75% (9/12, exact 95% CI 43–95%) of dogs in the Vaccine group were considered cured. Similar, but slightly lower cure rates of 64% and 50% were observed for dogs in the Glucantime

(7/11, exact 95% CI 31–89%) and Vaccine + Glucantime treatment groups (5/10, exact 95% CI 19–81%), respectively (Table 2). A response rate of the vaccine group was at least comparable, if not better than that observed in animals treated with Glucantime (64% cure) and contrasts with the poor outcome for dogs in the Control arm. The survival curves for the Vaccine alone and Vaccine + Glucantime groups are nearly identical for the first 24 months (Fig. 1), only diverging at the 36-month evaluation mark (not statistically significant, P = 0.487 by the logrank test). While chemotherapy alone showed a relatively rapid decline during the first 6 months after initiation of treatment, its course thereafter mimicked the declines observed for the other two treatment groups. Over the life of the study, aminophylline there were no significant differences in survival rates between the different treatment groups

(P > 0.30 for all pair-wise comparisons by the logrank test). Because of the apparent therapeutic efficacy of the Vaccine when administered alone and because no immunological analyses were performed as part of the Open Trial, a second trial was performed. Trial #2 was performed as a blinded study. Dog allocation into a study group was based on the enrollment order and followed a chart prepared before the start of the study. Mean values ± SD of each study group’s initial clinical scores were 6.4 ± 2.3 (range: 3–9, where a larger score means more severe clinical symptoms) for the Saline group, 6.4 ± 1.5 (range: 4–8) for the Adjuvant group, and 7.5 ± 2.1 (range: 5–12) for the Vaccine group. Thus, at study inclusion the Vaccine-group dogs had a higher mean CS (7.5 vs. 6.4) with a larger range (7 vs.