LEISH-F3 + GLA-SE and the LEISH-F3 + MPL-SE Vaccine

Who cannot join

• 1. History of possible infection with Leishmania or previous exposure to Leishmania vaccines or experimental products containing GLA-SE. 2. Veterans who served in the military in the Middle East (Iran, Iraq), Afghanistan, or any other areas endemic to Leishmania. 3. Travelers to, or immigrants from, areas endemic to Leishmania (Appendix D). Certain countries have endemic leishmaniasis only in certain regions of the country.The study PI (Principle Investigator) or a designated clinician may review the travel history with a potential candidate to determine if travel included areas of the country with endemic leishmaniasis. 4. Body temperature >/= 100.4 degrees Farenheit (>/=38.0 degrees Celsius) or acute illness within 3 days before vaccination (subject may be rescheduled). 5. A positive serum or urine pregnancy test within 24 hours prior to vaccination (if female of childbearing potential as defined in Inclusion Criterion 2), women who are planning to become pregnant from 30 days prior to entering the study until 90 days after the final study vaccination, or women who are breastfeeding. 6. Immunosuppression as a result of an underlying illness or treatment or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months. 7. An active neoplastic disease (excluding nonmelanoma skin cancer) or a history of any hematologic malignancy. Active neoplastic disease is defined as neoplastic disease or treatment for neoplastic disease within the past 5 years 8. A history of autoimmune disease (systemic lupus, rheumatoid arthritis, scleroderma, polyarteritis, thyroiditis, etc). 9, Used an immunosuppressive or immunomodulatory drug such as >0.5 mg/kg/day or >/= 20 mg total dose/day of prednisone orally or >800 microgram of inhaled beclomethasone for 2 or more consecutive weeks within 6 months prior to the first vaccination (Nasal and topical steroids are allowed). 10. A diagnosis of schizophrenia, bipolar disease, or history of hospitalization for a psychiatric condition or previous suicide attempt. 11. A history of treatment for any other psychiatric disorder in the past 3 years that increases the risk to the subject in the opinion of the investigator. 12. A history of receiving immunoglobulin or other blood product within the previous 3 months before vaccination or a history of donating whole blood within the past two months or other blood derivatives within 2 weeks. 13. Received or plan to receive any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks of any study vaccination. 14. An acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses or is not generally seen in healthy, normal subjects. (This includes, but is not limited to, known cardiac disease, pulmonary disease, liver disease, renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients.) 15. Subjects with a history of previous anaphylaxis or severe allergic reaction to vaccines, eggs, or unknown allergens or known allergy to components of the vaccine. 16. Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month before vaccination in this study or expect to receive an experimental agent during the 18 month study period. 17. Any condition that would, in the opinion of the investigator, place them at an unacceptable risk of injury, render them unable to meet the requirements of the protocol, or that may interfere with successful completion of the study. 18. A history of alcohol or drug abuse du ring the previous 1 year, for example, daily excessive alcohol use or frequent binge drinking as determined by the investigator, or chronic marijuana abuse or any other illicit drug use. 19. Presence of tattoos that would preclude evaluation of the injection site. Subject Exclusion Criteria for Unvaccinated Substudy Control Population 1. History of possible infection with Leishmania or previous exposure to Leishmania vaccines. 2. Veterans who served in the military in the Middle East (Iran, Iraq), Afghanistan, or any other areas endemic to Leishmania. 3. Travelers to, or immigrants from, areas endemic to Leishmania (Appendix D). Certain countries have endemic leishmaniasis only in certain regions of the country. The study PI or a designated clinician may review the travel history with a potential candidate to determine if travel included areas of the country with endemic leishmaniasis. 4. Body temperature >/=100.4 degrees F (>/=38.0 degrees C) or acute illness within 3 days before vaccination (subject may be rescheduled). 5. Immunosuppression as a result of an underlying illness or treatment or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months. 6. An active neoplastic disease (excluding nonmelanoma skin cancer) or a history of any hematologic malignancy. Active neoplastic disease is defined as neoplastic disease or treatment for neoplastic disease within the past 5 years. 7. A history of autoimmune disease (systemic lupus, rheumatoid arthritis, scleroderma, polyarteritis, thyroiditis, etc). 8. Used an immunosuppressive or immunomodulatory drug such as >0.5 mg/kg/day or >/=20 mg total dose/day of prednisone orally or >800 mcg of inhaled beclomethasone for 2 or more consecutive weeks within 6 months prior to phlebotomy (Nasal and topical steroids are allowed). 9. A diagnosis of schizophrenia, bipolar disease, or history of hospitalization for a psychiatric condition or previous suicide attempt. 10. A history of treatment for any other psychiatric disorder in the past 3 years. 11. A history of receiving immunoglobulin or other blood product within the previous 3 months before vaccination or a history of donating whole blood within the past two months or other blood derivatives within 2 weeks. 12. Received or plan to receive any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks of any study vaccination. 13. An acute or chronic medical condition that, in the opinion of the investigator, would interfere with the evaluation of responses or is not generally seen in healthy, normal subjects. (This includes, but is not limited to, known cardiac disease, pulmonary disease, liver disease, renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients.)