Phase 1 Clinical Trial of ID93+GLA-SE Vaccine in BCG-vaccinated Healthy Adolescent

NCT03806699 | Unknown Phase 1 FDA Drug

• 1 other identifier: CT-QTP101-002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate safety, immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in BCG-vaccinated QFT-negative healthy adolescent. The healthy adolescent will all have had the childhood TB vaccine called BCG, and all of them must have a negative result for a blood test for exposure to the bacteria that cause TB (QuantiFERON-TB Gold Plus, or "QFT"). Study participants will be followed for 12 months after the last injection for safety reasons. Blood will be drawn for laboratory tests for safety and immunogenicity tests. The study hypothesis is that the vaccine is safe and immunogenic in this study population.

Conditions

Tuberculosis

Keywords

Tuberculosis, TB, vaccine, adjuvant

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Solicited (local and systemic reactogenicity), unsolicited (all other adverse events, including laboratory assessments and vital signs), serious AEs and AEs of special interest.

  Solicited AEs for 7 days following each injection, unsolicited AEs for 28 days after each injection, SAEs and AESIs for 12 months after the last injection.

Secondary Outcomes (1)

• Humoral and cellular immunogenicity assays

  Days 0, 28, 56, 84, and 12 months after last injection.

Study Arms (3)

Low dose ID93+GLA-SE

EXPERIMENTAL

Participants will receive 0.5 mL (2 μg ID93 + 5 μg GLA-SE) intramuscular injection (IM) into deltoid area, three times in 4-week intervals on Days 0, 28, and 56.

Biological: ID93+GLA-SE

High dose ID93+GLA-SE

EXPERIMENTAL

Participants will receive 0.5 mL (10 μg ID93 + 5 μg GLA-SE) IM injection into deltoid area, three times in 4-week intervals on Days 0, 28, and 56.

Biological: ID93+GLA-SE

Control group

PLACEBO COMPARATOR

Participants will receive 0.5 mL (physiological saline) IM injection into deltoid area, three times on 4-week intervals on Days 0, 28, and 56.

Biological: Placebo

Interventions

Placebo BIOLOGICAL

Sterile normal saline

Control group

ID93+GLA-SE BIOLOGICAL

ID93 is a recombinant protein antigen comprising 4 antigens from Mycobacterium tuberculosis (Mtb). The adjuvant GLA-SE is a TLR4 agonist in a stable oil-in-water emulsion.

High dose ID93+GLA-SE; Low dose ID93+GLA-SE

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female who is ≥14 and \<19 years of age.
• History of BCG vaccination that is confirmed through medical examination (i.e., asking a subject about his/her condition) or presence of a scar.
• Adolescent who are QuantiFERON®-TB Gold Plus negative at screening.
• Body mass index(BMI) ≥19 and ≤33 (kg/m2) who's Body weight≥40kg at screening.
• Able to comply with the scheduled visits and are expected to continue working in the current medical institution and be available for a continuous follow-up by the investigator via provided contact information
• Only for female subjects of childbearing potential:
• Must be HCG-negative from serum or urine pregnancy test, at screening;
• Agreed to use one of the following acceptable birth control methods to avoid pregnancy until the end of study (Visit 9): hormonal contraceptives, intrauterine device(IUD) or intrauterine system (IUS), tubal ligation or combination of barrier methods (combined use of barrier methods such as male condoms, female condoms, cervical cap, diaphragm, sponge or implant).
• Subjects who understand the study procedures and voluntarily decide to participate in the study and sign the informed consent form.

You may not qualify if:

• History of severe chronic disease that may compromise the safety of the subject during the study (e.g., 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).
• Body temperature ≥ 38℃ at the time of randomization or within 24 hours before randomization, from acute fever, acute respiratory diseases, or active infection.
• Malignant tumors or a history of malignant tumors.
• Plans to have surgery during the study period.
• Impaired immune functions including autoimmune disease or immunodeficiency disease.
• History of Guillain-Barre syndrome.
• Subjects with a history of anaphylaxis or severe allergic reaction to vaccines, eggs or other allergens.
• Clinically significant abnormal laboratory values for any of the following tests conducted in the study center, prior to randomization:
• Hemoglobin, hematocrit, absolute neutrophil count, absolute lymphocyte count or platelet count: \< LLN (lower limit of normal)
• White blood cell count: \>ULN (upper limit of normal) or \<LLN (lower limit of normal) (i.e., must be within normal limits)
• ALT, AST, total bilirubin, alkaline phosphatase, creatinine or blood urea nitrogen(BUN): \>ULN (upper limit of normal)
• Received an immunosuppressant, immunity-modifying drug or other treatment that may affect the immune system including cytotoxic anti-cancer agents or radiotherapy, within 3 months before the randomization.
• Use of systemic steroids (equivalent to daily prednisone ≥ 15mg/day for more than 14 days), inhaled or intranasal steroids, within 3 months before randomization; however, use of topical corticosteroids are acceptable, regardless of dose.
• Use of immunoglobulin or blood products within 3 months before randomization or plans to use them during the study period.
• Human Immunodeficiency Virus (HIV) positive at screening.

Sponsors & Collaborators

• Quratis Inc.: lead

Study Sites (1)

HALLYM UNIV. Chuncheon Sacred Heart Hospital

Chuncheon, 24253, South Korea

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Yu Hwa Choi

  Quratis Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Since the vials of ID93+GLA-SE and placebo control (normal saline) and their appearances after preparation are different, for double-blinding of the study, the study nurse who administers the study drug or the study pharmacist who stores and manages the study drug will be unblinded to maintain the quality of study blinding. Additionally, an unblinded study monitor will be responsible for confirming the quantity and release of the study drugs. Unblinded study personnels and unblinded study monitor should only be involved in the duties related to administration and/or recording of the study drug, and must not be involved in other duties that may break double-blinding of the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to one of three groups: low dose vaccine, high dose vaccine, or placebo

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 16, 2019
• Study Start: April 2, 2019
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)