Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults

Inclusion Criteria

• Males and females 18 to 55 years of age.
• In good general health as confirmed by a medical history and physical exam, vital signs*, and screening laboratories conducted no more than 30 days prior to study injection administration.

*Temperature 54 bpm, systolic blood pressure ≤140 mmHg and >89 mmHg, diastolic blood pressure ≤90 mmHg and ≥60 mmHg.

NOTE: Athletically trained subjects with a pulse ≥40 may be enrolled at the discretion of the principal investigator or designated licensed clinical investigator.

• Screening laboratory values within normal limits: sodium, potassium, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, random glucose, total WBC count, hemoglobin, and platelet count.
• Negative HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
• Urine dipstick for protein and glucose (negative to trace protein are acceptable).
• Women of childbearing potential* in sexual relationships with men must agree to practice acceptable contraception** for the 30-day period before Day 0 through 90 days after the last study injection.

*Not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or 40 mIU/ml.

**Includes, but is not limited to, sexual abstinence, monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject receiving study product, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing ®, and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill").

• Able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study.
• Provide written informed consent before initiation of any study procedures.
• Willing to abstain from donating whole blood or blood derivatives until 90 days after the final study injection.

Exclusion Criteria

• Previous exposure to ID93 vaccines or experimental products containing GLA-SE.
• History of treatment for active or latent tuberculosis infection.
• History or evidence of active or documented latent tuberculosis, or positive QuantiFERON®-TB Gold test.
• Shared a residence within the last year prior to randomization with an individual on anti-tuberculosis treatment or with culture or smear positive tuberculosis.
• Received a tuberculin skin test within 3 months (90 days) prior to randomization.
• History of autoimmune disease or immunosuppression.
• Used immunosuppressive medication (e.g., oral or injected steroids) within 3 months prior to randomization (inhaled and topical corticosteroids are permitted).
• Received any investigational drug therapy or investigational vaccine within past 6 months prior to randomization, or planned participation in any other investigational study during the study period.
• Received investigational TB vaccine at any time prior to randomization.
• Received any vaccine within 30 days prior to the first study vaccination and no planned immunizations between Day 0-84 or Day 210-224 due to the washout period prior to immunology blood draws.
• History or laboratory evidence of immunodeficiency state including but not limited to laboratory indication of HIV-1 infection at screening.
• History of allergic disease or reactions, likely to be exacerbated by any component of the study vaccine.
• History of allergic reaction to kanamycin-related antibiotics.
• Subjects with a history of previous anaphylaxis or severe allergic reaction to vaccines or unknown allergens.
• Previous medical history that may compromise the safety of the subject in the study, including but not limited to: severe impairment of pulmonary fu