Dr. Mitchell will be responsible for ensuring that all study data is accurately documented within patient CRFs by the research nurse and study coordinator. All AEs and serious adverse events (SAE) will be reviewed jointly by Drs. Mitchell, and Gururangan to assess whether deemed vaccine related and reporting to the DSMB when deemed necessary. Drs. Mitchell, Gururangan, and external si te key personnel will have a standing monthly conference call where this protocol and other collaborative projects are thoroughly reviewed. All relevant protocol issues including amendments, accrual, and any treatment related events are discussed during th is meeting. The detailed budget for this proposal has been allocated to cover the supply costs and personnel efforts required to meet the study objects. Dr. Mitchell , as the PI, will function as the coordinating investigator for supply expenditures related to this study and will be responsible for timely submission of required study progress reports. New intellectual property relative to this project is not foreseen, and therefore it is unlikely that additional disclosures will result from this project. Publication decisions and authorship issues will be decided according to the relative contributions of the PIs.