It will be labeled with the patient’s study number, will not visually identify the patient, and will not include the face or distinguishing birthmarks or tattoos. Photographs will be electronically stored on a password protected computer in a locked office in the vaccine or clinical laboratory facility at each site. As per FDA regulations, each patient’s photograph will be kept for two years after submission of a NDA and then destroyed. These results will also be recorded in the immune response database. 4.5 Discontinuation of protocol-specific therapy Protocol-specific therapy may be discontinued for any of the following reasons: • Progressive disease • Unacceptable toxicity as described in the protocol o Please refer to sections 3.4 (Safety Considerations) for the management of cardiac issues (symptomatic and asymptomatic), hematologic toxicity and neutropenic infections, as well as robust local reactions and delayed urticarial reactions. Adverse events that do not respond to either dose modification (as described) or clinical management of the reaction will result in discontinuation from the study. o Please refer to section 4.6 (Patient Discontinuation) for a list of severe adverse reactions warranting discontinuation from the study. 31 Protocol: 2014-0443 Version 2.1 Version Date: 11 April 2016 • Patient election to discontinue therapy (for any reason) • Physician’s judgment 4.6 Patient discontinuation Those patients who display significant reactions (i.e. severe anaphylactic reaction immediately after vaccine administration) or toxicities will be discontinued from the study as determined by the PI. They will be followed by the study investigator until resolution of the adverse event. Inoculations will be immediately halted if any serious adverse reactions occur to include: death, life-threatening adverse drug experience (i.e., severe anaphylactic reaction immediately after vaccine administration), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other important medical events that may not result in death, be life-threatening, or require hospitalization but which, when based upon appropriate judgment of the PI, be determined to jeopardize the patient or require medical or surgical intervention to prevent an outcome listed above. Any death or grade 4 adverse drug experience found at least possibly related to the experimental vaccine will result in suspension of patient enrollment to the study. If the SAE is determined to be unrelated to the study drug, inoculations may be re-started if the patient desires to continue and it is safe for them to do so as determined by the PI and Sponsor. For robust local, systemic > Grade 3, and > Grade 2 hypersensitivity reactions, as evaluated under CTCAE v4.03, will result in dose reduction or discontinuation as discussed (section 3.4.2). Patients may withdraw from the study at any time and for any reason. A patient may be asked to withdraw from the study by the PI if they are not compliant with the timing of the inoculation series, observation period, or return visits to monitor for study-associated toxicities. Additionally, if the PI determines that it is no longer safe for a patient to continue in the trial for any reason, they may be withdrawn. Because it is not known whether these inoculations might harm an unborn child, patients who are pregnant, plan on becoming pregnant, or who are breast- feeding will not be enrolled into the study. Women of childbearing potential will take a urine pregnancy test before starting this study and prior to each inoculation; a positive test result will terminate the patient’s participation in the study. Patients will be counseled to avoid becoming pregnant while participating in this study, and that in order to prevent pregnancy they should either have no sexual relations or use a reliable type of birth control. They will be counseled 32 Protocol: 2014-0443 Version 2.1 Version Date: 11 April 2016 that with the exception of hysterectomy, bilateral oophorectomy, or tubal ligation, birth control methods are not totally effective in preventing pregnancy, and that the only ways to completely avoid the risk of the vaccine or immunoadjuvant alone to an unborn baby are (1) avoid becoming pregnant, or (2) do not receive these inoculations. Patients will be counseled to avoid becoming pregnant for at least 6 months after receiving the inoculations as pregnancy within this time after inoculation administration may be a risk to an unborn baby. If a patient is discontinued from the study for an adverse event or pregnancy, they will continue to be followed for resolution of adverse event and clinical recurrences unless the patient withdraws consent for further study evaluation.