Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults
Condition: Pulmonary TB
MeSH terms: Tuberculosis, Pulmonary
Intervention: ID93 + GLA-SE
Intervention description: The single-vial lyophilized vaccine will be reconstituted with WFI. For the two-vial presentation, the lyophilized ID93 will be reconstituted with WFI and mixed with liquid GLA-SE.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: All clinical staff and the participants are blinded to treatment, with the exception of the clinical pharmacist who prepares the vaccines and syringes.
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine, recombinant, adjuvant, GLA-SE, ID93

Summary:

      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).
    

Eligibility criteria:

        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.