The majority of AEs were due to administration site reactions. Most administration site reactions were mild or moderate in severity. Some more severe administration site reactions including swelling and redness were reported in the 3 - and 10- mg R -DOTAP cohorts. Most administration site reactions resolved the same day or within a few days. Per the subject symptom diary, administration site reactions were more severe and of longer duration in subjects in the 10- mg R -DOTAP cohort. No clinically significant differences in the types and pattern of TEAEs were observed between Vaccinations 1, 2, or 3. No DLTs were observed; thus, the MTD was the 10- mg R -DOTAP dose. No serious adverse events (SAEs), study discontinuations due to adverse events, or deaths occurred.