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

NCT03722472 | Completed Phase 1 Results DMC FDA Drug

• 3 other identifiers: IDRI-TBVPX-120DMID 17-0104272201400041C-0-0-1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Pulmonary TB

Keywords

Vaccine, recombinant, adjuvant, GLA-SE, ID93

Outcome Measures

Primary Outcomes (4)

• Local Injection Site Reactogenicity

  The number of subjects experiencing solicited local injection site reactions within 7 days following each study injection.

  7 days following each injection

• Systemic Reactogenicity

  The number of subjects experiencing solicited systemic reactions within 7 days following each study injection.

  7 days following each injection

• All Adverse Events

  The number of subjects spontaneously reporting adverse events from Day 0 through Day 84.

  Day 0 - 84

• Serious Adverse Events

  The number of serious adverse events considered related to any of the study injections reported at any point during the study period.

  Day 0 - 421

Secondary Outcomes (6)

• IgG Antibody Response Rate

  Days 0, 14, 56, 70, 84, and 224

• IgG Antibody Response Magnitude

  Days 0, 14, 56, 70, 84, and 224

• Cytokine Response

  Days 0, 14, 56, 70, 84, and 224

• Cytokine Response

  Days 0, 14, 56, 70, 84 and 224

• T Cell Response

  Days 0, 7, 14, 56, 63, 70, 84 and 224

Study Arms (2)

Single-vial ID93 + GLA-SE

EXPERIMENTAL

Single-vial presentation of ID93 + GLA-SE. Participants will receive two intramuscular (IM) injections of the vaccine on Days 0 and 56. 2 mcg ID93 and 5 mcg GLA-SE in 0.5 mL volume will be given per injection.

Biological: ID93 + GLA-SE

Two-vial ID93 + GLA-SE

ACTIVE COMPARATOR

Two-vial presentation of ID93 + GLA-SE. Participants will receive two intramuscular (IM) injections of the vaccine on Days 0 and 56. 2 mcg ID93 and 5 mcg GLA-SE in 0.5 mL volume will be given per injection.

Biological: ID93 + GLA-SE

Interventions

ID93 + GLA-SE BIOLOGICAL

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.

Single-vial ID93 + GLA-SE; Two-vial ID93 + GLA-SE

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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").
• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Access to Advanced Health Institute (AAHI): lead
• National Institutes of Health (NIH): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Saint Louis University - Center for Vaccine Development

St Louis, Missouri, 63104, United States

Location

Related Publications (1)

• Sagawa ZK, Goman C, Frevol A, Blazevic A, Tennant J, Fisher B, Day T, Jackson S, Lemiale F, Toussaint L, Kalisz I, Jiang J, Ondrejcek L, Mohamath R, Vergara J, Lew A, Beckmann AM, Casper C, Hoft DF, Fox CB. Safety and immunogenicity of a thermostable ID93 + GLA-SE tuberculosis vaccine candidate in healthy adults. Nat Commun. 2023 Mar 6;14(1):1138. doi: 10.1038/s41467-023-36789-2.

  PMID: 36878897 RESULT

Related Links

• Safety and immunogenicity of a thermostable ID93 + GLA-SE tuberculosis vaccine candidate in healthy adults

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Christopher Fox PhD
• Organization: Access to Advanced Health Institute (AAHI)

Christopher.Fox@aahi.org

(206) 381-0883

Study Officials

• Christopher Fox, PhD

  Access to Advanced Health Institute (AAHI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All clinical staff and the participants are blinded to treatment, with the exception of the clinical pharmacist who prepares the vaccines and syringes.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 29, 2018
• Study Start: October 2, 2018
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: June 1, 2023
• Results First Posted: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)