Phase 1 LEISH-F3 Vaccine Trial in Healthy Adult Volunteers

Exclusion Criteria

• •Subjects who meet ANY of the following criteria will be excluded from the study (ineligible):
• •History of possible infection with Leishmania or previous exposure to Leishmania vaccines or experimental products containing GLA-SE.
• •Veterans who served in the military in the Middle East (Iran, Iraq), Afghanistan, or any other areas endemic to Leishmania.
• •Travelers to, or immigrants from, areas endemic to Leishmania.
• •Participation in another experimental protocol or receipt of any investigational products within the past 3 months.
• •Treatment with immunosuppressive drugs (e.g., oral or injected steroids, such as prednisone; high dose inhaled steroids) or cytotoxic therapies (e.g., chemotherapy drugs or radiation) within the past 6 months.
• •Received a blood transfusion within the past 3 months.
• •Donated blood products (platelets, whole blood, plasma, etc.) within past 1 month.
• •Received any vaccine within past 1 month. Note: No immunizations while on study with the exception of seasonal influenza vaccine which should not be given until 1 month after the third study injection (Day 84).
• •History of autoimmune disease or other causes of immunosuppressive states.
• •History or evidence of any acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic, or renal disorders, controlled hypertension), or use of medication that, in the opinion of the Principal Investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
• •Rash, tattoos or any other dermatological condition that could adversely affect the vaccine injection site or interfere with its evaluation.
• •BMI greater than 30 kg/m2
• •Hypertension (systolic greater than 150 or diastolic greater than 95).
• •History of significant psychiatric illness with current use of medication.
• •Known or suspected alcohol or drug abuse within the past 6 months.
• •Chronic smoker (less than 20 pack years).
• •Subjects with a history of previous anaphylaxis or severe allergic reaction to vaccines, eggs, or unknown allergens.
• •Subjects who are unlikely to cooperate with the requirements of the study protocol.