A Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Explore the Immunogenicity of the Tuberculosis (TB) Vaccine Candidate QTP101 (ID93+GLA-SE) in Older Adults (Aged 55~74 Years)

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 74
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Republic of Korea
Chung-Ang University Gwangmyeong Hospital
RECRUITING
Gwangmyeong
The Catholic University of Korea Seoul ST.MARY'S Hospital
RECRUITING
Seoul
Yonsei University Severance Hospital
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Contact Information
Primary
Jinhee Lee, DVM, PhD
lee8583@quratis.com
+82-2-569-3378
Time Frame
Start Date: 2025-05-09
Estimated Completion Date: 2026-12
Participants
Target number of participants: 144
Treatments
Experimental: BCG-vaccinated, HIV-negative, QFT-negative and middle-aged adults (55-64) with a low dose of QTP101
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.
Experimental: BCG-vaccinated, HIV-negative, QFT-negative and middle-aged adults (55-64) with a high dose of QTP101
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.
Placebo_comparator: BCG-vaccinated, HIV-negative, QFT-negative and middle-aged adults (55-64) with the placebo
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.
Experimental: BCG-vaccinated, HIV-negative, QFT-negative and older adults (65-74) with a low dose of QTP101
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.
Experimental: BCG-vaccinated, HIV-negative, QFT-negative and older adults (65-74) with a high dose of QTP101
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.
Placebo_comparator: BCG-vaccinated, HIV-negative, QFT-negative and older adults (65-74) with the placebo
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.
Experimental: BCG-vaccinated, HIV-negative, QFT-positive and middle-aged adults (55-64) with a low dose of QTP101
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.
Experimental: BCG-vaccinated, HIV-negative, QFT-positive and middle-aged adults (55-64) with a high dose of QTP101
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.
Placebo_comparator: BCG-vaccinated, HIV-negative, QFT-positive and middle-aged adults (55-64) with the placebo
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.
Experimental: BCG-vaccinated, HIV-negative, QFT-positive and older adults (65-74) with a low dose of QTP101
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.
Experimental: BCG-vaccinated, HIV-negative, QFT-positive and older adults (65-74) with a high dose of QTP101
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.
Placebo_comparator: BCG-vaccinated, HIV-negative, QFT-positive and older adults (65-74) with the placebo
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.
Related Therapeutic Areas
Sponsors
Leads: Quratis Inc.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials