Institutional review board In accordance with federal regulations, an Institutional review board that complies w ith the regulations in 21CFR 56 must review and approve this protocol and the informed consent form prior to initiation of the study. In addition the study cannot be instituted without FDA approval of the vaccine formulations. 6304p Protocol 118 04/06/2016 B. Consent The investigator s or their associates must explain verbally and in writing the nature, duration and purpose of the study and possible consequences of the treatment. Subjects must also be informed that they may withdraw from the study at any time and for any reason withou t jeopardizing their future treatment. In accordance with Federal regulations (21 CFR 312) all subjects must sign the IRB approved consent form in the presence of a witness. C. Reporting adverse events Adverse events will be reported using the terminol ogy and grading scale of the NCI’s Cancer Therapy Evaluatio n Program (CTEP) Common Terminology Criteria for Adverse Events (CTC AE), version 3 .0. A copy of the CTC AE version 3.0 can be downloaded from the CTEP home page (http://ctep.info.nih.gov). Guideli nes for adverse events reporting to the FDA and the NCI are described in the DSMP, Appendix C. The Monitoring Plan (as mandated by the NIH/NCI) Policy and Procedure for this phase I study is described in Appendix C. D. Specimen Handling Upon entry into the study each subject will be assigned a unique patient number (UPN). All materials collected on that subject will be labeled with their UPN. Lymphocytes, sera and tissue collected will be stored in a liquid nitrogen freezer in the laboratory of the Pr incipal Investigator. 6304p Protocol 118 04/06/2016 15.