In addition, these patients may be at increased risk of complications and side effects due to immunologic changes resulting from this agent. The effects of yeast-brachyury vaccine on the developing human fetus are unknown. For this reason, women of child- bearing potential and men must agree to use adequate contraception (hormonal or barrier method; abstinence) prior to study entry and for the duration of study participation. 10.2 P ARTICIPATION OF CHILDREN Because no dosing or AE data are currently available on the use of MVA -brachyury -TRICOM vaccine in patients < 18 years of age, children are excluded from this study but may be eligible for future pediatric trials. 53 Abbreviated Title: Phase I MVA -Brachyury -TRICOM Version Date: September 14, 2016 Confidential 10.3 EVALUATION OF BENEFITS AND RISKS/DISCOMFORTS All care will be taken to minimize side effects, but they can be un predictable in nature and severity. This study may involve unforeseeable risks to patients.