A Phase 1, Double-Blind, Randomized Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Single-Vial Lyophilized ID93 + GLA-SE Vaccine Administered Intramuscularly in Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Pulmonary TB
- Sponsor
- Access to Advanced Health Institute (AAHI)
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Serious Adverse Events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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).
Detailed Description
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).
Investigators
Eligibility Criteria
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 \<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.
- •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 \< 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").
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.
Outcomes
Primary Outcomes
Serious Adverse Events
Time Frame: Day 0 - 421
The number of serious adverse events considered related to any of the study injections reported at any point during the study period.
All Adverse Events
Time Frame: Day 0 - 84
The number of subjects spontaneously reporting adverse events from Day 0 through Day 84.
Local Injection Site Reactogenicity
Time Frame: 7 days following each injection
The number of subjects experiencing solicited local injection site reactions within 7 days following each study injection.
Systemic Reactogenicity
Time Frame: 7 days following each injection
The number of subjects experiencing solicited systemic reactions within 7 days following each study injection.
Secondary Outcomes
- T Cell Response(Days 0, 7, 14, 56, 63, 70, 84 and 224.)
- Cytokine Response(Days 0, 14, 56, 70, 84 and 224)
- IgG Antibody Response Rate(Days 0, 14, 56, 70, 84, and 224)
- IgG Antibody Response Magnitude(Days 0, 14, 56, 70, 84, and 224)