Actively Recruiting
ID93+GLA-SE Vaccine Against Tuberculosis in Older Adults Aged 55-74
Led by Quratis Inc. · Updated on 2025-06-17
144
Participants Needed
4
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 study visits and maintain contact with the investigator
- Male or female aged 55 to 74 years at consent
- Capable of providing written informed consent in person with a witness
- Positive or negative QuantiFERON-TB test result, or documented prior positive test
- Negative HIV test at screening
- Documented BCG vaccination or visible BCG scar
- Body Mass Index between 19 and 33 kg/m2
- Healthy or with well-controlled chronic diseases
- Female participants must be non-fertile (e.g., post-menopausal, surgical infertility) or agree to use contraception during and 6 months after treatment with negative pregnancy tests
- Male participants must agree to use barrier contraception and ensure partner uses contraception during and 6 months after treatment
- Understand study procedures and voluntarily consent
- Informed about latent tuberculosis chemoprophylaxis and agree to participate despite non-consent to chemoprophylaxis
You will not qualify if you...
- Suspected or current tuberculosis, history of tuberculosis, or treatment for latent tuberculosis infection at screening or first dose
- Use of other investigational products or unapproved drugs within 6 months prior or planned during trial
- Previous receipt of investigational tuberculosis vaccine
- Positive HIV test at screening
- Positive hepatitis C or hepatitis B surface antigen positive and antibody negative at screening
- Participation in other clinical trials or exposure to investigational/non-investigational products during trial
- Receipt of immunoglobulins or blood products within 90 days prior or planned during trial
- Pregnant or breastfeeding females
- Medical or psychiatric conditions that prevent trial participation, including fever, active infection, recent malignancy, respiratory, cardiovascular, neurological diseases, recent COVID-19 infection or symptoms, autoimmune or immunodeficiency diseases, significant medical histories, bleeding disorders, or transplantation history
- Radiation therapy within 12 months prior, except non-lung radiation
- Planned surgery during trial
- History of severe allergic reactions or anaphylaxis to vaccines or allergens
- Abnormal lab tests, ECG, or chest X-ray unsuitable for participation
- Chronic immunosuppressant or immunomodulatory drug use within 6 months prior
- Cognitive impairment
- Close or household contact with active tuberculosis cases in indoor environments for extended periods
AI-Screening
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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
CONTACT
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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