Phase 1 LEP-F1 + GLA-SE Vaccine Trial in Healthy Adult Volunteers

Inclusion Criteria

• •1. Males and females 18 years to 55 years of age.
• •2. Must be in good general health as confirmed by a medical history and physical exam.
• •3. Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the day of each study vaccination, must not be breast-feeding, and are required to use one of the following methods of contraception from enrollment (Day 0) in study until 30 days after last injection (only if in sexual relationships with men): hormonal (e.g. oral, transdermal, intravaginal, implant, or injection); double barrier (i.e., condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD) or system (IUS); vasectomized partner (6 months minimum); or abstinence; bilateral tubal ligation (if no conception post-procedure); tubal occlusion; or bilateral salpingectomy. These precautions are necessary due to unknown effects that LEP-F1 + GLA-SE might cause in a fetus or newborn infant. Women are considered non-child-bearing potential if they are post-menopausal (defined as at least 12 months spontaneous amenorrhea and confirmed with FSH \> 40 mIU/ml) or have had documented hysterectomy and/or oophorectomy.
• •4. The following screening laboratory values must be within the normal ranges or not clinically significant as determined by the Investigator and approved by the Medical Monitor: sodium, potassium, BUN, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, fasting glucose, total WBC count, hemoglobin, and platelet count. Abnormal results may be repeated once for confirmation at Investigator discretion.
• •5. The following serology tests must be negative: HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), QuantiFERON®-TB Gold (QFT), and hepatitis C virus (HCV) antibody.
• •6. Negative test for recreational drugs and alcohol per Clinical Research Unit standards.
• •7. Normal or not clinically significant urinalysis as determined by the study clinician or designee. Abnormal results may be repeated at Investigator discretion.
• •8. Must be capable of completing a study memory aid in English.
• •9. Must give informed consent, be able and willing to make all evaluation visits, be reachable by telephone or personal contact by the study site personnel, and have a permanent address.