Volunteers are followed on the study for a minimum of 18 months after the first immunization. Safety is evaluated by closely monitoring for local and systemic adverse reactions during the course of the trial. Phase Phase II A phase two trial follows phase one. It consists of a larger, randomized sample of patients. The purpose of a phase two trial is to see if the drug is effective at doing what the manufacturer claims it should do.
Researchers also watch closely for unexpected adverse reactions.
Normal history and physical examination. Differential within institutional normal limits or approval of site physician. Negative hepatitis B surface antigen. Normal urine dipstick with esterase and nitrite. History of immunodeficiency, chronic illness, or autoimmune disease.