Logistic regression analysis of Day 49 antibody titers as determined by ELISA and PRNT failed to find a correlation between Modulators circulating antibody titers and survival for any of the fV3526 formulations indicating, in this study, that antibody titers were not predictive of survival. In this study, we evaluated the immunogenicity and efficacy of fV3526 formulations administered IM as an alternative to SC vaccination. Despite receiving less fV3526 per dose, all

IM vaccinated mice survived SC challenge with 1 × 104 pfu VEEV TrD regardless AC220 clinical trial of fV3526 formulation (Table 5). Similar to SC vaccination, mice in this arm of the study did not display signs of illness or loss of body weight following SC challenge. All sham-vaccinated mice succumbed to infection on Day 7 post-challenge. Similar to SC vaccination, induction of protective Lapatinib solubility dmso immunity to infectious aerosols following IM vaccination was more difficult to achieve compared to SC challenge. No statistically significant differences were observed in survival among the vaccinated groups, however, the mean time to death in mice vaccinated with fV3526 + Alhydrogel™

was longer compared to other formulations (p < 0.01). The onset of clinical signs of disease was closely associated with decreases in body weight and was similar for 3 of the 4 vaccine formulations with the onset of symptoms being Day 2 post-challenge and continuing through Day 13. In the group of mice vaccinated with fV3526 + CpG + Alhydrogel™, signs of disease were not observed until Day 3 and were resolved by Day 9. All sham vaccinated mice were clinically ill by Day 2 post-challenge and all succumbed to disease between Day 4 and TCL 7. In general, IM vaccinated mice

showed a trend toward higher survival rates following aerosol challenge compared to mice vaccinated SC with the same formulations (compare Table 4 and Table 5). In fact, survival was statistically higher in mice vaccinated IM with fV3526 + CpG (9 of 10 survived) compared to mice vaccinated with the same formulation SC (3 of 9 survived) (p < 0.05, Logistic regression analysis). The reproducibility of the efficacy data following aerosol challenge was evaluated for fV3526 formulated with adjuvants containing CpG. In an additional 1 or 2 independent iterations, mice were IM vaccinated with fV3526 + CpG + Alhydrogel™ or fV3526 + CpG and challenged by the aerosol route using the same dosages and schedules as in earlier studies. In each group, survival percentages ranged from 70 to 90% with an average 80% survival for fV3526 + CpG and 85% survival for fV3526 + CpG + Alhydrogel™ following aerosol challenge (Fig. 3).