Open-Label Safety Study of Three-Antigen Leishmania Polyprotein With Adjuvant MPL-SE in Healthy Adults in India

Inclusion Criteria: * Males and females ≥ 18 years and \< 55 years of age. * Must be in good general health as confirmed by a medical history and physical exam. * DAT titer must be \<1:400 and rK39 serology negative (for inclusion in the DAT-negative group) or DAT titer ≥1:1600 (for inclusion in the DAT-positive group). * The following laboratory blood tests must have values within the normal ranges at screening (Appendix 4): sodium, potassium, urea, ALT, AST, total bilirubin, creatinine, alkaline phosphatase, glucose, hemoglobin, total WBC count and platelet count. * The following serology tests must be negative at screening: HIV 1/2, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody. All subjects will receive HIV related counseling prior to testing. Subjects with positive HIV test results will receive counseling at the University and will be referred to the national AIDS control program for treatment if appropriate. * Subjects must give written informed consent, be willing and able to attend all required visits, have a permanent address, and be reachable by study site personnel. * Female subjects of childbearing potential must have a negative urine pregnancy test at screening, a negative urine pregnancy test within 24 hours before study injection, must not be breast-feeding, and are required to use adequate contraception through Day 84 of the study. These precautions are necessary due to unknown effects that Leish-111f + MPL-SE might have in a fetus…