If patients suffer any physical injury as a result of participation in this study, immediate medical treatment is available at the Warren Grant Magnuson Clinical Center, Bethesda, Maryland. Although no compensation is available, any injury will be evaluated and treated in keeping with the benefits or care to which patients are entitled under applicable regulations. 10.4 C ONSENT AND ASSENT PROCESS AND DOCUMENTATION The investigational nature and objectives of this trial, the procedures involved, and their attendant risks and discomforts, potential benefits, and potential alternative therapies wi ll be explained to the patient and a signed informed consent document obtained. Once the patient has reviewed the consent, an investigator on this study will discuss the specifics of the consent and request the patient sign once all questions are satisfactorily answered. Moreover, any experimental invasive procedure will require a separate consent form. All listed associate investigators (except those listed on the cover sheet as not being able to make clinical decisions) are permitted to obtain informed consent. 10.4.1 Telephone (Re- )Consent Procedure Reconsent on this study may be obtained via telephone according to the following procedure: the informed consent document will be sent to the subject. An explanation of the study will be provided over the telephone after the subject has had the opportunity to read the consent form. The subject will sign and date the informed consent. A witness to the subject’s signature will sign and date the consent. The original informed consent document will be sent back to the consenting investigator who will sign and date the consent form with the date the consent was obtained via telephone. A fully executed copy will be returned via mail for the subject’s records. The informed consent process will be documented on a progress note by the consenting investigator and a copy of the informed consent document will be kept in the subject’s research record. 54 Abbreviated Title: Phase I MVA -Brachyury -TRICOM Version Date: September 14, 2016 Confidential 10.4.2 Informed Consent of Non-English Speaking Subjects If there is an unexpected enrollment of a research participant for whom there is no translated extant IRB approved consent document, the principal investigator and/or those authorized to obtain informed consent will use the Short Form Oral Consent Process as described in MAS Policy M77-2, OSHRP SOP 12, 45 CFR 46.117 (b) (2), 21 CFR 50.27 (b) (2). The summary that will be used is the English version of the extant IRB approved consent document. Signed copies of both the English version of the consent and the translated short form will be given to the subject or their legally authorized representative and the signed original will be filed in the medical record. Unless the PI is fluent in the prospective subject’s language, an interpreter will be present to facilitate the conversation (using either the long translated form or the short for m). Preferably someone who is independent of the subject (i.e., not a family member) will assist in presenting information and obtaining consent. Whenever possible, interpreters will be provided copies of the relevant consent documents well before the cons ent conversation with the subject (24 to 48 hours if possible). We request prospective IRB approval of the use of the short form process for non- English speaking subjects and will notify the IRB at the time of continuing review of the frequency of the use of the Short Form. 11 PHARMACEUTICAL INFOR MATION 11.1 MVA -B RACHYURY -TRICOM 11.1.1 Source MVA-brachyury-TRICOM is an active cancer immunotherapy. This phase I study is being conducted under an IND held by the Center for Cancer Research (CCR), National Cancer Institute (NCI). Bavarian Nordic, I nc. is the manufacturer of MVA -brachyury -TRICOM and has transferred sufficient product to the NCI to complete this phase I study. 11.1.2 Toxicity MVA- BN-derived vectors that encode heterologous (non-vaccinia virus) antigens are being developed for the treatment of cancer. In GLP studies, MVA-BN and MVA- BN-derived vectors have been administered to 5 different animal species, including primates. In addition, MVA- BN and MVA- BN-derived vectors have been administered in clinical trials to over 7800 human subjects, including immunodeficient individuals. No marked toxicity and no drug- related serious AEs have occurred in any of these studies. 11.1.3 Formulation and P reparation MVA- Brachyury -TRICOM is supplied as a frozen aqueous suspension in 2 mL cle ar borosilicate glass vials. The closure is a sterile bromobutyl rubber stopper, crimped with an aluminum cap and covered with a polypropylene closure. Each vial contains one 0.5 mL dose of MVA-Brachyury-TRICOM, which is 2.0 x 10 8 Infectious Units (Inf. U.). The thawed product will be a slightly turbid to milky suspension which may contain clumps or aggregates. 55 Abbreviated Title: Phase I MVA -Brachyury -TRICOM Version Date: September 14, 2016 Confidential MVA-brachyury-TRICOM is supplied frozen in single- use vials. Each vial must be thawed at room temperature for approximately 10–15 minutes prior to preparation, and should not be re- frozen after thawing.