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A Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Explore the Immunogenicity of the Tuberculosis Vaccine Candidate QTP101 (ID93+GLA-SE) in Older Adults Aged 55 to 74 Years
Led by Quratis Inc. · Updated on 2025-06-17
144
Participants Needed
4
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety and immune response of the investigational tuberculosis vaccine candidate QTP101 (ID93+GLA-SE) in older adults aged 55 to 74 years who have received the BCG vaccine. This Phase 1 randomized, double-blind, placebo-controlled trial includes participants with either positive or negative QuantiFERON-TB (QFT) test results, aiming to address the high risk of TB in aging populations. The study explores how the vaccine stimulates the immune system and assesses safety to guide future vaccine development. Participants are randomly assigned to one of three groups receiving either a low dose or high dose of QTP101 or a placebo. Each participant receives three intramuscular injections on Day 0, Day 28, and Day 56. The study includes specific age groups (55-64 and 65-74 years) and monitors safety carefully, especially in older adults, using a sentinel subgroup approach. Follow-up includes regular visits at 1, 6, and 12 months after the final injection. During the study, participants undergo multiple blood draws to measure antibody levels and immune cell responses before vaccination and at several time points up to 48 weeks after the last dose. Safety is monitored through assessments of adverse events, physical exams, vital signs, and laboratory tests from the screening phase until 12 months post-vaccination. The trial collects detailed data to evaluate both the vaccine's safety profile and its ability to trigger protective immune responses over time.
CONDITIONS
Brief Title
ID93+GLA-SE Vaccine Against Tuberculosis in Older Adults Aged 55-74
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to comply with all scheduled visits and monitored continuously by the investigator
- Male or female aged 55 to 74 years at consent
- Able to provide written informed consent with a witness
- Positive or negative QuantiFERON-TB test result at screening or documented prior positive result
- Negative HIV test at screening
- Record of BCG vaccination or visible BCG scar
- Body Mass Index between 19 and 33 kg/m2
- Healthy or with well-controlled chronic diseases
- Females must be non-fertile or agree to use contraception during and 6 months after vaccination, with negative pregnancy tests
- Males must agree to use barrier contraception during and 6 months after vaccination
- Understand trial procedures and voluntarily agree to participate
- Recommended for TB prevention but decline chemoprophylaxis
You will not qualify if you...
- Suspected or active tuberculosis, history of tuberculosis, or treatment for latent tuberculosis infection
- Use of investigational or unapproved drugs within 6 months or planned during the trial
- Previous investigational tuberculosis vaccine
- Positive HIV, HCV, or certain hepatitis B tests at screening
- Concurrent participation in other clinical trials or exposure to investigational products
- Received immunoglobulins or blood products within 90 days before first dose or planned during trial
- Pregnant or breastfeeding females
- Acute fever, respiratory disease, active infection, or recent COVID-19 infection
- Recent or history of malignancies
- Recent treatment for respiratory conditions or high-risk pulmonary diseases
- Serious cardiovascular, neurological, autoimmune, or immunodeficiency diseases
- Significant medical histories judged unsuitable by investigator
- Radiation therapy within 12 months, especially to lungs
- Planned surgery during trial
- History of severe allergic reactions or anaphylaxis to vaccines
- Clinically significant abnormal lab, ECG, or chest X-ray findings
- Chronic use of high-dose immunosuppressants recently
- Cognitive impairment
- Close or household contact with active tuberculosis patient
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive three intramuscular injections of their assigned treatment (QTP101 vaccine or placebo) on Day 0, Day 28, and Day 56 to evaluate safety and immunogenicity.
3 visits (in-person) for injections
Duration - 12 months
Participants are monitored for safety and immunogenicity, including adverse events and immune responses, with follow-up visits up to 12 months after the final injection.
3 visits (in-person) at 1, 6, and 12 months post-final injection
Trial Site Locations
Total: 4 locations
1
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, Gyeonggi-do, South Korea, 14353
Actively Recruiting
2
Yonsei University Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
3
The Catholic University of Korea Seoul ST.MARY'S Hospital
Seoul, South Korea, 06634
Actively Recruiting
4
Ajou University Hospital
Suwon, South Korea, 16499
Actively Recruiting
Research Team
J
Jinhee Lee, DVM, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
12
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