Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults
Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults
This is a phase 1, double-blind, randomized clinical trial to evaluate the safety,
 tolerability, and immunogenicity of single-vial lyophilized ID93 + GLA-SE compared to the
 two-vial presentation consisting of lyophilized ID93 and liquid GLA-SE administered as two IM
 injections in healthy adult subjects (aged 18 - 55).
Subjects will receive a total of two doses administered IM on Days 0 and 56. Subjects will be
 monitored for approximately 421 days (one year following the last study injection), including
 safety laboratory analyses done just prior to and 7 days following each study injection.
 Tears and nasal swabs will be obtained for exploratory antibody analysis at Days 0, 70, and
 224. Blood samples will be obtained for immunological assays (secondary and exploratory) at
 Days 0, 7, 14, 56, 63, 70, 84, and 224).
Inclusion Criteria:

 1. Males and females 18 to 55 years of age.

 2. 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 <38°C, respiratory rate < 17 breaths pm, heart rate ≤100 bpm and >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.

 3. Screening laboratory values within normal limits: sodium, potassium, ALT, AST, total
 bilirubin, alkaline phosphatase, creatinine, random glucose, total WBC count,
 hemoglobin, and platelet count.

 4. Negative HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus
 (HCV) antibody.

 5. Urine dipstick for protein and glucose (negative to trace protein are acceptable).

 6. 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 < 1 year of the last menses if menopausal). Post-menopausal
 defined as at least 12 months spontaneous amenorrhea and confirmed with FSH > 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").

 7. 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.

 8. Provide written informed consent before initiation of any study procedures.

 9. Willing to abstain from donating whole blood or blood derivatives until 90 days after
 the final study injection.

 Exclusion Criteria:

 1. Previous exposure to ID93 vaccines or experimental products containing GLA-SE.

 2. History of treatment for active or latent tuberculosis infection.

 3. History or evidence of active or documented latent tuberculosis, or positive
 QuantiFERON®-TB Gold test.

 4. Shared a residence within the last year prior to randomization with an individual on
 anti-tuberculosis treatment or with culture or smear positive tuberculosis.

 5. Received a tuberculin skin test within 3 months (90 days) prior to randomization.

 6. History of autoimmune disease or immunosuppression.

 7. Used immunosuppressive medication (e.g., oral or injected steroids) within 3 months
 prior to randomization (inhaled and topical corticosteroids are permitted).

 8. 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.

 9. Received investigational TB vaccine at any time prior to randomization.

 10. 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.

 11. History or laboratory evidence of immunodeficiency state including but not limited to
 laboratory indication of HIV-1 infection at screening.

 12. History of allergic disease or reactions, likely to be exacerbated by any component of
 the study vaccine.

 13. History of allergic reaction to kanamycin-related antibiotics.

 14. Subjects with a history of previous anaphylaxis or severe allergic reaction to
 vaccines or unknown allergens.

 15. Previous medical history that may compromise the safety of the subject in the study,
 including but not limited to: severe impairment of pulmonary function from
 tuberculosis infection or other pulmonary disease; chronic illness with signs of
 cardiac or renal failure; suspected progressive neurological disease; or uncontrolled
 epilepsy or infantile spasms.

 16. Known or suspected alcohol or drug abuse within the past 5 years.

 17. Smokes 1 pack or more of cigarettes per day.

 18. History of keloid formation or excessive scarring.

 19. History or evidence on physical examination of any systemic disease or any acute or
 chronic illness that, in the opinion of the investigator, may interfere with the
 evaluation of the safety or immunogenicity of the vaccine, including axillary
 lymphadenopathy.

 20. Received a blood transfusion or immunoglobulin within the past 3 months prior to
 randomization.

 21. Donated blood products (platelets, whole blood, plasma, etc.) within past 1 month
 prior to randomization.

 22. Presence of any febrile illness, oral temperature of >100.4 °F/38.0 °C within 24 hours
 of study injection administration. Such subjects may be re-evaluated for enrolment
 after resolution of illness.

 23. Positive serum (at screening visit only) or urine pregnancy test at screening or
 within 24 hours prior to study injection for women of childbearing potential.

 24. Breastfeeding at any time throughout the study.

 25. Rash, tattoos, or any other dermatological condition on the upper anterolateral arm
 that could adversely affect the vaccine injection site or interfere with its
 evaluation.

 26. BMI <18 or >35 kg/m2.

 27. Any medical or neuropsychiatric condition which, in the Investigator's opinion, would
 render the subject incompetent to provide informed consent or unable to provide valid
 safety observations and reporting.

 28. Cancer or treatment for cancer within 3 years of study injection administration.
 Persons with a history of cancer who are disease-free without treatment for 3 years or
 more are eligible. Persons with treated and uncomplicated basal cell carcinoma of the
 skin are eligible.

 29. Subjects unlikely to cooperate with the requirements of the study protocol.