Phase 1 Tuberculosis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to attend all required visits during the trial and can be contacted by the research team throughout.
• People who are between 55 and 74 years old at the time of giving consent.
• People (or their legal representatives) who are able to sign a consent form in person, in front of a witness.
• People who have either a positive or negative QFT test (a blood test for tuberculosis exposure) at screening — or who have documented records of a previous positive QFT result (in which case, repeat testing may not be needed).
• People who test negative for HIV at the screening visit.
• People who have a record of receiving a BCG vaccine, or who have a BCG scar on their body.
• People whose Body Mass Index (BMI) falls between 19 and 33 at the time of screening.
• People who are generally healthy, or who have a long-term (chronic) health condition that is well managed.
• Female participants must show evidence at the screening visit that they meet one of the following:
  • They are not able to become pregnant — defined as being post-menopausal (no periods for at least 12 months after stopping all hormone treatments and over 55 years old), or having had a documented surgical procedure such as removal of the uterus, both ovaries, or both fallopian tubes (note: tubal ligation alone does not meet this criterion).
  • They are potentially able to become pregnant but agree to use appropriate contraception during the treatment period and for 6 months after the last dose, and agree to pregnancy blood and urine tests at required visits, all of which must come back negative.
• Male participants who have not had a vasectomy must agree to use barrier contraception (such as condoms), and both they and their partner must agree to use appropriate contraception during the treatment period and for 6 months after the last dose.
• People who understand the trial procedures and voluntarily choose to take part.
• People who have been advised to consider tuberculosis prevention treatment, have been fully informed about it, and choose to join this trial instead of that preventive treatment — and who clearly state they do not wish to receive the preventive drug treatment.

Who may not be able to join:

• People who are suspected of having tuberculosis, have had tuberculosis in the past, are currently being treated for tuberculosis or latent tuberculosis infection, or have previously been treated for latent tuberculosis infection.
• People who have taken part in another trial or used an unapproved drug within the past 6 months, or who plan to do so during the trial.
• People who have previously received an experimental tuberculosis vaccine.
• People who test positive for HIV at the screening visit.
• People who test positive for hepatitis C (HCV), or who test positive for a hepatitis B surface antigen (HBsAg) and negative for hepatitis B surface antibody (HBsAb) at screening.
• People who are taking part in another clinical trial at the same time, or who will be exposed to other trial or non-trial products during this trial period.
• People who have received immunoglobulins or blood products within the 90 days before the first dose, or who plan to receive them during the trial.
• People who are pregnant or breastfeeding.
• People with certain medical or psychiatric conditions that the lead doctor determines make participation unsafe, including:
  • A fever of 38°C or higher, acute respiratory illness, or active infection at the time of joining.
  • A current or recent (within the past 5 years) cancer diagnosis.
  • Respiratory conditions where treatment was needed for a moderate or severe flare-up within the past 2 years (people with well-controlled asthma or early-stage COPD may still be eligible at the lead doctor's discretion; people with conditions such as silicosis may be excluded regardless of timing).
  • Serious heart conditions such as heart failure, coronary artery disease, heart attack, or uncontrolled high blood pressure.
  • Neurological conditions such as epilepsy, seizures within the past 3 years, migraines, stroke, brain disease, or Guillain-Barré syndrome.
  • A confirmed COVID-19 infection within the 90 days before the screening visit, or ongoing COVID-19 symptoms from an infection that occurred more than 90 days before screening.
  • Autoimmune thyroid disease, other autoimmune conditions, or immune deficiency conditions.
  • Other significant medical histories involving the liver, kidneys, hormonal system, urinary system, or muscles and bones, as judged by the lead doctor.
  • A history of a rare swelling disorder called hereditary or idiopathic angioedema.
  • A history of organ or bone marrow transplant.
  • A history of platelet or bleeding disorders, significant bleeding or bruising from injections or blood draws, or current use of blood-thinning medication.
• People who have received radiation therapy within the past 12 months — or who have ever received radiation therapy to the lungs, regardless of when it occurred.
• People who have surgery planned at any point during the trial period.
• People who have had a severe allergic reaction or anaphylaxis to a vaccine or other substance in the past.
• People with significantly abnormal results on lab tests, heart tracing (ECG), or chest X-ray at screening, as judged by the lead doctor — including people whose chest X-ray shows a type of scarring that may suggest a past tuberculosis infection that healed on its own, even without a known history of tuberculosis treatment.
• People who have regularly used immunosuppressant or immune-modifying medications within the 6 months before the first dose — specifically, high-dose steroid tablets (such as prednisolone at more than 15 mg per day for more than 14 days continuously). Note: steroid creams, nasal sprays, inhalers, and eye drops are permitted.
• People who the lead doctor considers unsuitable for any other reason.
• People with cognitive impairment (difficulties with thinking, memory, or understanding).
• People who live with, or have had prolonged close indoor contact with, someone who has active tuberculosis — including family members or housemates who have shared a living space regularly for at least 3 months, or others who have spent at least 8 hours per day or a total of 40 or more hours in an enclosed indoor space with an active tuberculosis patient.

Important: Always verify eligibility with the trial site directly before applying.