ID93+GLA-SE Vaccine Against Tuberculosis in Older Adults Aged 55-74

NCT06714513 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: CT-QTP101-007RS-2024-0033748331538
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the safety and explore the immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in the Bacillus Calmette-Guérin (BCG)-vaccinated older adults aged 55 to 74 with negative or positive result on the QuantiFERON-TB (QFT) test. Eligible participants will be randomly assigned based on age group and the QFT test results to receive either QTP101 (Dose 1 and Dose 2) or placebo. Safety and immunogenicity will be monitored from the first dose until 12 months after the final dose of the investigational product. Blood samples for immunogenicity analysis will be collected at five-time points: before the first dose (Day 0), 4 weeks after the first dose (Day 28), 4 weeks after the second dose (Day 56), 4 weeks after the third dose (Day 84), and 48 weeks after the third dose (Day 392). Once the safety and immunogenicity follow-up is completed 48 weeks after the third dose (Day 392) for the last enrolled participant, a final report will be compiled based on the collected data.

Conditions

Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (27)

• Safety Endpoint - Immediate Adverse Events

  Immediate adverse events within 30 minutes after administration

  Within 30 minutes after each administration

• Safety Endpoint - Solicited local and systemic Adverse Events

  Solicited local/systemic AEs occurred up to 7 days after administration

  Occurred up to 7 days after each administration

• Safety Endpoint - Unsolicited local and systemic Adverse Events

  Unsolicited local/systemic AEs occurred up to 28 days after administration

  Occurred up to 28 days after each administration

• Safety Endpoint - Serious Adverse Events and Adverse Event of of Special Interest

  Serious AE (SAEs) and AE of special interest (AESI) occurred from the first administration up to 48 weeks after the last administration

  Occurred from the first administration up to 48 weeks after the last administration

• Safety Endpoint - Laboratory assessment (Hematological Test)

  Hematological test for each participant

  From screening to the end of visit at 48 weeks after the last administration

• Safety Endpoint - Laboratory assessment (Hematochemical test)

  Hematochemical test for each participant

  From screening to the end of visit at 48 weeks after the last administration

• Safety Endpoint - Laboratory assessment (Urine test)

  Urine test for each participant

  From screening to the end of visit at 48 weeks after the last administration

• Safety Endpoint - Vital Signs (Body temperature)

  Body weight will be measured at each scheduled visit after the administration of the investigational product for each participant.

  From screening to the end of visit at 48 weeks after the last administration

• Safety Endpoint - Vital Signs (Pulse)

  Pulse rate will be measured for each participant.

  From screening to the end of visit at 48 weeks after the last administration

• Safety Endpoint - Vital Signs (Respiratory rate)

  Respiratory rate will be measured for each participant.

  From screening to the end of visit at 48 weeks after the last administration

• Safety Endpoint - Vital Signs (Blood pressure)

  Systolic and diastolic blood pressure will be measured for each participant.

  From screening to the end of visit at 48 weeks after the last administration

• Immunogenicity Endpoint - Humoral immunity (GMT)

  Geometric mean titer (GMT) of antigen-specific IgG measured with ELISA

  Before 1st administration, 4 weeks after 1st administration, 4 weeks after 2nd administration, 4 and 48 weeks after 3rd administration

• Immunogenicity Endpoint - Humoral immunity (GMFR)

  Geometric mean fold rise (GMFR) of antigen-specific IgG measured with ELISA

  Before 1st administration, 4 weeks after 1st administration, 4 weeks after 2nd administration, 4 and 48 weeks after 3rd administration

• Immunogenicity Endpoint - Humoral immunity (SRR)

  Seroresponse rate (SRR), defined as a 4-fold rise in antibody titer of antigen-specific IgG measured with ELISA from Baseline

  Before 1st administration, 4 weeks after 1st administration, 4 weeks after 2nd administration, 4 and 48 weeks after 3rd administration

• Immunogenicity Endpoint - Cellular immunity (ICS)

  The ratio and amount of antigen-specific Th1 cytokine-secreting cells measured with intracellular cytokine staining (ICS)

  Before 1st administration, 4 weeks after 1st administration, 4 weeks after 2nd administration, 4 and 48 weeks after 3rd administration

• Immunogenicity Endpoint - Cellular immunity (RR)

  Cell response rate (RR), defined as a 4-fold rise in the amount of antigen-specific Th1 cytokine-secreting cells from the baseline.

  Before 1st administration, 4 weeks after 1st administration, 4 weeks after 2nd administration, 4 and 48 weeks after 3rd administration

• Safety Endpoint - Physical examinations (General Appearance)

  Overall health and appearance, including posture and obvious abnormalities.

  At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.

• Safety Endpoint - Physical examinations (Skin)

  Inspection for rashes, lesions, discoloration, or other visible skin issues

  At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.

• Safety Endpoint - Physical examinations (Head/Neck)

  Examination of the skull, scalp, lymph nodes, and thyroid gland

  At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.

• Safety Endpoint - Physical examinations (Chest/Lungs)

  Assessment of respiratory sounds, chest wall movement, and breathing patterns using inspection and auscultation

  At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.

• Safety Endpoint - Physical examinations (Heart)

  Evaluation of heart sounds, rhythm, and potential murmurs through auscultation and palpation

  At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.

• Safety Endpoint - Physical examinations (Abdomen)

  Palpation and auscultation for organ enlargement, tenderness, or abnormal bowel sounds

  At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.

• Safety Endpoint - Physical examinations (Genitourinary System)

  Examination of genital and urinary organs, focusing on abnormalities or patient-reported symptoms (if applicable)

  At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.

• Safety Endpoint - Physical examinations (Limbs)

  Inspection and assessment for swelling, deformities, or movement limitations

  At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.

• Safety Endpoint - Physical examinations (Musculoskeletal System)

  Examination of joints, muscles, and bones for pain, swelling, or restricted mobility

  At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.

• Safety Endpoint - Physical examinations (Nervous System)

  Assessment of reflexes, motor and sensory functions, and coordination

  At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.

• Safety Endpoint - Physical examinations (Other)

  Any additional assessments based on the participant's symptoms or clinical findings

  At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.

Study Arms (12)

BCG-vaccinated, HIV-negative, QFT-negative and middle-aged adults (55-64) with a low dose of QTP101

EXPERIMENTAL

This study arm evaluates the safety and immunogenicity of a low dose of QTP101 in BCG-vaccinated, HIV-negative, QFT-negative adults aged 55-64. Participants receive 2 μg of ID93 and 5 μg of GLA-SE via intramuscular injection on Day 0, Day 28, and Day 56. The target population includes individuals without prior TB infection as indicated by the QFT-negative status. The primary objective is to assess safety, focusing on adverse events (AEs), and to explore immunogenicity through antibody titers and cytokine responses. Findings will provide critical insights into the vaccine's effects in middle-aged, previously uninfected individuals.

Biological: QTP101

BCG-vaccinated, HIV-negative, QFT-negative and middle-aged adults (55-64) with a high dose of QTP101

EXPERIMENTAL

This study arm evaluates the safety and immunogenicity of a high dose of QTP101 in BCG-vaccinated, HIV-negative, QFT-negative adults aged 55-64. Participants receive 10 μg of ID93 and 5 μg of GLA-SE via intramuscular injection on Day 0, Day 28, and Day 56. This group focuses on individuals without prior TB infection, as indicated by their QFT-negative status. The primary objective is to assess the safety profile, including adverse events (AEs), and to evaluate the immune response, such as antibody titers and cytokine production. The findings will help determine the vaccine's suitability for middle-aged individuals and guide future dose optimization.

Biological: QTP101

BCG-vaccinated, HIV-negative, QFT-negative and middle-aged adults (55-64) with the placebo

PLACEBO COMPARATOR

This study arm serves as a placebo comparator for BCG-vaccinated, HIV-negative, QFT-negative adults aged 55-64. Participants receive intramuscular injections of sterile normal saline (placebo) on Day 0, Day 28, and Day 56. The purpose of this arm is to provide a baseline for evaluating the safety and immunogenicity outcomes of QTP101 by comparing the incidence of adverse events (AEs) and immune responses against those observed in the experimental groups. This group includes individuals without prior TB infection, as indicated by their QFT-negative status, and is essential for assessing the specific effects of the investigational vaccine.

Biological: Placebo

BCG-vaccinated, HIV-negative, QFT-negative and older adults (65-74) with a low dose of QTP101

EXPERIMENTAL

This study arm evaluates the safety and immunogenicity of a low dose of QTP101 in BCG-vaccinated, HIV-negative, QFT-negative older adults aged 65-74. Participants receive 2 μg of ID93 and 5 μg of GLA-SE via intramuscular injection on Day 0, Day 28, and Day 56. This arm focuses on individuals without prior TB infection, as indicated by their QFT-negative status. The primary objective is to assess the safety profile, including adverse events (AEs), and to explore the vaccine's immunogenicity through antibody titers and cytokine responses. The findings will provide key data on the vaccine's effects in older, previously uninfected populations.

Biological: QTP101

BCG-vaccinated, HIV-negative, QFT-negative and older adults (65-74) with a high dose of QTP101

EXPERIMENTAL

This study arm investigates the safety and immunogenicity of a high dose of QTP101 in BCG-vaccinated, HIV-negative, QFT-negative older adults aged 65-74. Participants receive 10 μg of ID93 and 5 μg of GLA-SE via intramuscular injection on Day 0, Day 28, and Day 56. The arm focuses on individuals without prior TB infection, as indicated by their QFT-negative status. The primary aim is to evaluate the safety profile, including adverse events (AEs), and to assess the immunogenicity of the high-dose vaccine through antibody titers and cytokine production. The findings will help determine the vaccine's suitability and dose optimization for older populations.

Biological: QTP101

BCG-vaccinated, HIV-negative, QFT-negative and older adults (65-74) with the placebo

PLACEBO COMPARATOR

This study arm serves as a placebo comparator for BCG-vaccinated, HIV-negative, QFT-negative older adults aged 65-74. Participants receive intramuscular injections of sterile normal saline (placebo) on Day 0, Day 28, and Day 56. The purpose of this arm is to establish a baseline for safety and immunogenicity assessments by comparing the incidence of adverse events (AEs) and immune responses against those observed in the experimental groups. This group includes individuals without prior TB infection, as indicated by their QFT-negative status, and plays a crucial role in evaluating the specific effects of the investigational vaccine.

Biological: Placebo

BCG-vaccinated, HIV-negative, QFT-positive and middle-aged adults (55-64) with a low dose of QTP101

EXPERIMENTAL

This study arm evaluates the safety and immunogenicity of a low dose of QTP101 in BCG-vaccinated, HIV-negative, QFT-positive middle-aged adults aged 55-64. Participants receive 2 μg of ID93 and 5 μg of GLA-SE via intramuscular injection on Day 0, Day 28, and Day 56. This arm targets individuals with prior latent or resolved TB infection, as indicated by their QFT-positive status. The primary objective is to assess the safety profile, focusing on adverse events (AEs), and to explore the vaccine's immunogenicity through antibody titers and cytokine responses. The results will provide valuable data on the vaccine's performance in previously exposed middle-aged adults.

Biological: QTP101

BCG-vaccinated, HIV-negative, QFT-positive and middle-aged adults (55-64) with a high dose of QTP101

EXPERIMENTAL

This study arm investigates the safety and immunogenicity of a high dose of QTP101 in BCG-vaccinated, HIV-negative, QFT-positive middle-aged adults aged 55-64. Participants receive 10 μg of ID93 and 5 μg of GLA-SE via intramuscular injection on Day 0, Day 28, and Day 56. This arm focuses on individuals with prior latent or resolved TB infection, as indicated by their QFT-positive status. The primary goal is to assess the safety profile, including adverse events (AEs), and to evaluate the immunogenicity of the high-dose vaccine by measuring antibody titers and cytokine responses. The findings will inform dose optimization and vaccine effectiveness in previously exposed middle-aged adults.

Biological: QTP101

BCG-vaccinated, HIV-negative, QFT-positive and middle-aged adults (55-64) with the placebo

PLACEBO COMPARATOR

This study arm serves as a placebo comparator for BCG-vaccinated, HIV-negative, QFT-positive middle-aged adults aged 55-64. Participants receive intramuscular injections of sterile normal saline (placebo) on Day 0, Day 28, and Day 56. The purpose of this arm is to establish a baseline for evaluating the safety and immunogenicity outcomes of QTP101 in individuals with prior latent or resolved TB infection, as indicated by their QFT-positive status. This comparison will help identify the specific effects of the investigational vaccine by contrasting it with the placebo group in terms of adverse events (AEs) and immune responses.

Biological: Placebo

BCG-vaccinated, HIV-negative, QFT-positive and older adults (65-74) with a low dose of QTP101

EXPERIMENTAL

This study arm evaluates the safety and immunogenicity of a low dose of QTP101 in BCG-vaccinated, HIV-negative, QFT-positive older adults aged 65-74. Participants receive 2 μg of ID93 and 5 μg of GLA-SE via intramuscular injection on Day 0, Day 28, and Day 56. This arm targets individuals with prior latent or resolved TB infection, as indicated by their QFT-positive status. The primary objective is to assess the safety profile, focusing on adverse events (AEs), and to explore the vaccine's immunogenicity through antibody titers and cytokine responses. The findings will provide critical insights into the vaccine's safety and effectiveness in previously exposed older populations.

Biological: QTP101

BCG-vaccinated, HIV-negative, QFT-positive and older adults (65-74) with a high dose of QTP101

EXPERIMENTAL

This study arm investigates the safety and immunogenicity of a high dose of QTP101 in BCG-vaccinated, HIV-negative, QFT-positive older adults aged 65-74. Participants receive 10 μg of ID93 and 5 μg of GLA-SE via intramuscular injection on Day 0, Day 28, and Day 56. This arm focuses on individuals with prior latent or resolved TB infection, as indicated by their QFT-positive status. The primary goal is to assess the safety profile, including adverse events (AEs), and to evaluate the vaccine's immunogenicity through antibody titers and cytokine responses. The results will inform dose optimization and effectiveness of the vaccine in older adults with prior TB exposure.

Biological: QTP101

BCG-vaccinated, HIV-negative, QFT-positive and older adults (65-74) with the placebo

PLACEBO COMPARATOR

This study arm serves as a placebo comparator for BCG-vaccinated, HIV-negative, QFT-positive older adults aged 65-74. Participants receive intramuscular injections of sterile normal saline (placebo) on Day 0, Day 28, and Day 56. The purpose of this arm is to establish a baseline for evaluating the safety and immunogenicity of QTP101 in individuals with prior latent or resolved TB infection, as indicated by their QFT-positive status. Comparing this group to the experimental arms will help identify the specific effects of the investigational vaccine in terms of adverse events (AEs) and immune responses.

Biological: Placebo

Interventions

QTP101 BIOLOGICAL

QTP101 consists of ID93 and GLA-SE. ID93 is a recombinant protein antigen comprising four antigens from Mycobacterium tuberculosis (Mtb). The adjuvant GLA-SE is a TLR4 agonist in a stable oil-in-water emulsion.

BCG-vaccinated, HIV-negative, QFT-negative and middle-aged adults (55-64) with a high dose of QTP101; BCG-vaccinated, HIV-negative, QFT-negative and middle-aged adults (55-64) with a low dose of QTP101; BCG-vaccinated, HIV-negative, QFT-negative and older adults (65-74) with a high dose of QTP101; BCG-vaccinated, HIV-negative, QFT-negative and older adults (65-74) with a low dose of QTP101; BCG-vaccinated, HIV-negative, QFT-positive and middle-aged adults (55-64) with a high dose of QTP101; BCG-vaccinated, HIV-negative, QFT-positive and middle-aged adults (55-64) with a low dose of QTP101; BCG-vaccinated, HIV-negative, QFT-positive and older adults (65-74) with a high dose of QTP101; BCG-vaccinated, HIV-negative, QFT-positive and older adults (65-74) with a low dose of QTP101

Placebo BIOLOGICAL

Sterile 0.9% normal saline

BCG-vaccinated, HIV-negative, QFT-negative and middle-aged adults (55-64) with the placebo; BCG-vaccinated, HIV-negative, QFT-negative and older adults (65-74) with the placebo; BCG-vaccinated, HIV-negative, QFT-positive and middle-aged adults (55-64) with the placebo; BCG-vaccinated, HIV-negative, QFT-positive and older adults (65-74) with the placebo

Eligibility Criteria

• Age: 55 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who can comply with all scheduled assessment visits during the clinical trial period and who can be continuously monitored by the investigator through the provided contact information
• Males or females aged 55 to 74 years at the time of consent
• Participants and/or legally authorized representatives who are capable of providing written informed consent (signed in person in the presence of a witness)
• Participants with either positive or negative QFT test results at the time of screening; QFT testing can be omitted in the following case: If participants have a documented history of a positive QFT test result, evidenced by submitted records or recorded in the EMR
• Participants with negative HIV test results at the time of screening
• Participants with a record of BCG vaccination or BCG scar directly
• Participants who fall within the following range in physical measurements at the time of screening: 19 ≤ Body Mass Index (BMI) ≤ 33 (kg/m\^2) BMI and weight results are rounded to the nearest whole number.
• Healthy participants or those with well-managed chronic diseases through medical history and clinical examination
• Female participants must provide evidence at the screening visit (Visit 1) that they meet one of the following criteria to be considered non-fertile:
• Non-fertile: Defined as post-menopausal or other infertility conditions. Post-menopausal women: No menstrual periods for at least 12 months after stopping all external hormone treatments and over 55 years old. Documented irreversible surgical infertility such as hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. However, tubal ligation is not permitted.
• Fertile: Women of childbearing potential who have not undergone sterilization must agree to use appropriate contraception during the investigational product administration period and for 6 months after the end of the investigational product administration. They must undergo a serum pregnancy test (β-hCG test) at the screening visit (Visit 1) and urine pregnancy tests (Urine-hCG test) at subsequent visits, with negative HCG results required.
• Male participants can be enrolled under the following conditions: Men who have not undergone vasectomy must agree to use barrier contraception (e.g., condoms) and agree that both they and their partner will use appropriate contraception during the investigational product administration period and for 6 months after the end of the investigational product administration.
• Participants who understand the clinical trial procedures, voluntarily decide to participate and sign the informed consent form
• Participants recommended for tuberculosis prevention treatment who have been adequately informed about and understand latent tuberculosis chemoprophylaxis, and voluntarily agree to participate in the clinical trial while expressing non-consent to the chemoprophylaxis

You may not qualify if:

• Participants who meet any of the following criteria must be excluded from enrollment.
• Participants who are suspected of having tuberculosis, have a history of tuberculosis, are currently undergoing treatment for tuberculosis, are being treated for latent tuberculosis infection, or have a history of medication treatment for latent tuberculosis infection at the time of the Screening (Visit 1) or the first administration (Visit 2)
• Participants who have received other investigational products or used unapproved drugs within 6 months prior to participating in the clinical trial or who plan to use them during the trial period
• Participants who have previously received an investigational tuberculosis vaccine
• Participants who test positive for HIV at the screening visit
• Participants who test positive for HCV or who test positive for HBsAg and negative for HBsAb in HBV tests at the screening visit
• Participants who are exposed to or will be exposed to investigational or non-investigational products during the clinical trial period or who participate in another clinical trial simultaneously
• Participants who have received immunoglobulins and/or any blood products within 90 days before the first administration of the investigational product or plan to receive them during the clinical trial period
• Pregnant or breastfeeding female
• Participants with the following medical or psychiatric conditions that make it impossible to conduct the clinical trial as judged by the principal investigator:
• Participants with acute fever (an arbitrary body temperature of 38°C or higher at the time of randomization or within 24 hours before randomization), acute respiratory disease, or active infection.
• Participants with malignancies or a history of malignancies within the past 5 years.
• Participants with respiratory diseases: who have received treatment for acute exacerbation or moderate exacerbation of a respiratory condition within 2 years prior to the first administration of the investigational product. (Participants with a history of high-risk pulmonary diseases, such as silicosis, may be excluded at the investigator's discretion, regardless of the treatment period or even if the history is beyond the past 2 years. However, participants with controlled asthma or COPD stage 0 (at-risk) may participate with judgment of the principal investigator.)
• Participants with serious cardiovascular diseases: congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension, etc.
• Participants with neurological diseases: epilepsy, seizures within 3 years before the first administration of the investigational products, migraines, strokes, encephalopathy, Guillain-Barre syndrome, etc.

Sponsors & Collaborators

• Quratis Inc.: lead

Study Sites (4)

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, Gyeonggi-do, 14353, South Korea

RECRUITING

Yonsei University Severance Hospital

Seoul, 03722, South Korea

RECRUITING

The Catholic University of Korea Seoul ST.MARY'S Hospital

Seoul, 06634, South Korea

RECRUITING

Ajou University Hospital

Suwon, 16499, South Korea

RECRUITING

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

Study Officials

• Jinhee Lee, DVM, PhD

  Quratis Inc.

  STUDY DIRECTOR

• Jae Chol Choi, MD, PhD

  Chung-Ang University Gwangmyeong Hospital

  PRINCIPAL INVESTIGATOR

• Youngmok Park, MD, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

• Kwang Joo Park, MD, PhD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

• Jinsoo Min, MD, PhD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinhee Lee, DVM, PhD

CONTACT

+82-2-569-3378; lee8583@quratis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 3, 2024
• Study Start: May 9, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be available following the publication of the study results in peer-reviewed journals. This is expected within \[specify timeframe, e.g., 6 months to 1 year\] after the completion of the study.
• Access Criteria: Access to the data will be limited to the information published in peer-reviewed journals. Additional data requests beyond the published information may be considered upon reasonable request and subject to institutional and ethical approvals.

Locations

KR (4)