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New treatment option for Tuberculosis, Pulmonary
Official title ID93+GLA-SE Vaccine Against Tuberculosis in Older Adults Aged 55-74
ClinicalTrials.gov ID: NCT06714513
What this study is testing
What is QTP101?
QTP101 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for tuberculosis, pulmonary.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 74. Healthy volunteers may be eligible.
You may be able to join if
- Participants who can comply with all scheduled assessment visits during the clinical trial period and who can be continuously monitored by the...
- 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...
- 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 with negative HIV test results at the time of screening
You likely can't join 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...
- Participants who have received other investigational products or used unapproved drugs within 6 months prior to participating in the clinical trial...
- 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
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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.
- Participants with a history of COVID-19 infection within 90 days before the screening visit (confirmed positive by NAAT or rapid antigen test) or who have not recovered from COVID-19-related symptoms after being...
- Participants with autoimmune hypothyroidism, autoimmune diseases, immunodeficiency diseases.
- Participants with other clinically significant medical histories related to the hepatobiliary system, kidneys, endocrine system, urinary system, musculoskeletal system, etc., as judged by the principal investigator.
- Participants with a history of hereditary or idiopathic angioedema.
- Participants with a history of organ or bone marrow transplantation.
- Participants with a history of platelet-related or bleeding disorders, a history of significant bleeding or bruising following intramuscular injection or venipuncture, or who are receiving anticoagulants.
- Participants who have received radiation therapy within 12 months before the first administration of the investigational product. However, those who have received radiation therapy to the lungs are excluded regardless...
- Participants who have surgery planned during the clinical trial period
- Participants with a history of severe allergic reactions or anaphylaxis to vaccines or other allergens
- Participants with clinically significant abnormal findings in laboratory tests, ECG, or chest X-ray at the screening visit as judged by the principal investigator to be unsuitable for participation. Participants with...
- Participants who have chronically received immunosuppressants or other immunomodulatory drugs within 6 months before the first administration of the investigational product
- High-dose corticosteroids (continuous use of doses exceeding 15 mg/day of prednisolone for more than 14 days)
- However, topical steroids, nasal sprays, inhalers, and eye drops are allowed regardless of the dose
- Participants who are deemed unsuitable for this clinical trial by the principal investigator for any other reasons
- Participants with cognitive impairment.
- Household contacts and close contacts who have been in an indoor environment with an active tuberculosis patient
- Household Contact: Family members and cohabitants who have been living in the same space or regularly interacting for at least 3 months.
- Close Contact: Individuals other than household contacts who have had direct contact in an enclosed indoor environment (e.g., classroom, office) for an extended period, defined as continuous or daily contact for at...
The study team makes the final eligibility decision.
Where it's taking place
- Gwangmyeong, Gyeonggi-do, South Korea
- Seoul, South Korea
- Suwon, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 74 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gwangmyeong, Gyeonggi-do, South Korea; Seoul, South Korea; Suwon, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.