Phase 2a ID93 + GLA-SE Vaccine Trial in TB Patients After Treatment Completion
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Intervention: Placebo; ID93 + GLA-SE
Intervention description: Placebo; ID93 + GLA-SE
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Tuberculosis; TB; Pulmonary; Vaccine; Adjuvant

Summary:

      The purpose of this study is to evaluate the safety and immunogenicity of ID93 + GLA-SE
      vaccine when administered to adult pulmonary Tuberculosis (TB) patients, following successful
      completion of TB treatment with confirmed bacteriologic cure, in preparation for a future
      Phase 2b prevention of TB recurrence trial in the same population.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females 18 to 60 years of age.

          2. Subjects must have been successfully treated, i.e., completed the scheduled course of
             TB treatment as per the prevailing South African national guidelines, for MTB
             culture-confirmed, drug sensitive pulmonary TB, as evidenced by a record of positive
             liquid MTB culture with formal drug sensitivity testing (DST) and/or by Xpert MTB/RIF
             test at baseline.

          3. Must have two separate samples showing bacteriologic confirmation of cure - defined in
             the first instance as Xpert MTB/RIF test negative, or, if Xpert MTB/RIF positive, as
             MTB liquid culture negative - on two successive occasions at least 30 days apart.
             Subjects who are sputum unproductive will be deemed Xpert MTB/RIF and MTB liquid
             culture negative.

          4. 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 injection, must
             not be breast-feeding, and be willing to avoid pregnancy for 3 months following first
             study injection. Women physically capable of pregnancy (not sterilized and still
             menstruating or within 1 year of the last menses if menopausal) in sexual
             relationships with men must use an acceptable method of avoiding pregnancy during this
             period. Acceptable methods of avoiding pregnancy include a sterile sexual partner,
             sexual abstinence (not engaging in sexual intercourse), hormonal contraceptives (oral,
             injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or
             the combination of a condom or diaphragm with spermicide gel.

          5. The following screening laboratory values must be within the laboratory reference
             range or, if abnormal, deemed not clinically significant and less than Grade 2
             severity on the FDA Toxicity Scale, as determined by the PI and LMM or Sponsor Medical
             Advisor: ALT, AST, total bilirubin, creatinine, total WBC count, hemoglobin, and
             platelet count.

          6. The HIV 1/2 antibody serology tests must be negative.

          7. 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 be willing
             to remain in the study area for the duration of the trial.

        Exclusion Criteria:

          1. TB treatment failure, as evidenced by clinical diagnosis or a positive MTB liquid
             culture at month 4 or 5 after starting treatment. A positive MTB liquid culture at, or
             after, end of treatment would exclude subjects from receiving further study
             injections.

          2. Previous course of TB treatment completed within 5 calendar years prior to obtaining
             baseline diagnostic sputum samples.

          3. Receipt of any investigational products or investigational drug in the past 6 months
             or investigational vaccine ever.

          4. Treatment with immunosuppressive drugs (e.g., oral or injected steroids, such as
             prednisone; high dose inhaled steroids) in the past 6 months. Topical steroids would
             be allowable.

          5. Received incomplete or investigational, or non-standard TB drug regimen, other than
             the prevailing current South African national guideline as reference standard, or poor
             adherence to TB treatment regimen.

          6. Diagnosed with rifampicin-resistant MTB strain (by Xpert MTB/RIF and/or culture and
             formal DST).

          7. History of autoimmune disease or other causes of immunosuppressive states.

          8. History or evidence of any acute or chronic illness (including diabetes mellitus,
             asthma), medical or surgical condition, or chronic heavy ethanol or drug use, or use
             of medication that, in the opinion of the Principal Investigator, may interfere with
             the evaluation of the safety or immunogenicity of the vaccine.

          9. Subjects with a history of previous anaphylaxis or severe allergic reaction to
             vaccines, eggs, or unknown allergens.

         10. Subjects who are unlikely to cooperate with the requirements of the study protocol.