- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, endocrinologic or renal disease by history, physical examination, and/or laboratory studies including urine testing. Levels of alanine aminotransferase (ALT), aspartate transaminase (AST), bilirubin greater than 2 times the upper limit of normal (ULN) or otherwise clinically significant as determined by the Principal Investigator (PI), will be exclusionary at baseline, prior to vaccination. Complete blood count (CBC) with differential outside of the normal reference range and deemed clinically significant by the PI.