Phase 3 Tuberculosis Trial, Recruiting

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

Who might be able to join this trial:

General community members (no tuberculosis history):

• People aged 3 years or older, of any gender
• People (or their guardian) who agree to take part and sign a consent form
• People (or their guardian) who are able to attend follow-up visits as required by the trial
• People with no history of tuberculosis (TB), whether affecting the lungs or other parts of the body
• People with no current TB-related symptoms — such as ongoing tiredness, mild fever in the afternoons, loss of appetite, night sweats, cough, chest pain, or chest tightness (for women, this also includes no unexplained changes to menstrual cycles)
• For a specific sub-group called the "triple-negative population": people whose results from two skin tests (one on each arm) and a blood test called IGRA all come back negative

People diagnosed with tuberculosis (including lung TB):

• People aged 3 years or older, of any gender
• Adults (18 and over) diagnosed with TB or lung TB according to the relevant Chinese national diagnostic standard; children aged 3–17 diagnosed with TB according to the relevant Chinese expert consensus guidelines
• This includes TB affecting the lungs or other parts of the body, and both new and returning cases
• People (or their guardian) who agree to take part and sign a consent form
• People (or their guardian) who are able to attend follow-up visits as required by the trial

People diagnosed with a lung disease that is not tuberculosis:

• People with a confirmed diagnosis of a non-TB lung condition (such as pneumonia, lung cancer, bronchitis, bronchiectasis, non-tuberculous mycobacterial disease, or chronic obstructive pulmonary disease), where the treating doctor has ruled out TB based on symptoms, imaging, and laboratory results
• People aged 3 years or older, of any gender
• People (or their guardian) who agree to take part and sign a consent form
• People (or their guardian) who are able to attend follow-up visits as required by the trial

Who may not be able to join:

For general community members:

• People with a known or suspected serious immune system disease or immune system damage or abnormality (HIV is an exception to this rule — confirm with trial site)
• People who have recently used certain immune-suppressing medications (such as medium or high doses of steroid drugs like prednisone) or immune-boosting medications within 3 days before the skin test, where the trial doctor assesses this could affect results (certain low-dose, short-term, or topically applied steroids may be permitted — confirm with trial site)
• People with a history of seizures, epilepsy, mental illness, or an immediate family member (parent, sibling, or child) with a history of mental illness
• People with a history of strong allergic reactions, such as known allergies to two or more medications or foods, or a known allergy to any ingredient in the trial's test product
• People currently experiencing an acute infectious illness (such as measles, whooping cough, or influenza), acute eye infection, acute ear infection, or widespread skin disease
• People with a current fever, or who have taken fever-reducing, pain-relieving, or anti-allergy medicines within 3 days before the skin test, where the trial doctor assesses this could affect results
• People with a severe skin infection (such as widespread infected skin sores or severe eczema)
• People who have taken part in another clinical drug trial within the 3 months before the skin test (placebo, certain lab tests, or non-contact devices may be exceptions — confirm with trial site)
• People who have received an inactivated vaccine within 7 days before the skin test, or a live vaccine within 28 days before the skin test
• Women who are pregnant or breastfeeding, or women of childbearing age who test positive on a pregnancy test before joining
• People with a history of drug abuse
• People whose past medical history, physical examination results, or likelihood of not being able to follow the trial requirements the trial doctor believes could affect the trial results (for example, tattoos in the skin test area)
• For the "triple-negative" sub-group only: people who have any reason they cannot receive a BCG vaccine, including immune deficiency (such as AIDS), current use of immune-suppressing drugs or radiation therapy, known allergy to BCG, current fever or acute infection (including active TB), or severe chronic illness affecting the heart, brain, blood vessels, or kidneys

For people with tuberculosis or non-TB lung disease:

• People with a known or suspected serious immune system disease or immune system damage or abnormality (HIV is an exception — confirm with trial site)
• People who have recently used certain immune-suppressing medications (such as medium or high doses of steroid drugs) or immune-boosting medications within 3 days before the skin test, where the trial doctor assesses this could affect results (certain low-dose, short-term, or topically applied steroids may be permitted — confirm with trial site)
• People with a history of seizures, epilepsy, mental illness, or an immediate family member with a history of mental illness
• People with a history of strong allergic reactions, such as known allergies to two or more medications or foods, or a known allergy to any ingredient in the trial's test product
• People currently experiencing an acute infectious illness, acute eye infection, acute ear infection, or widespread skin disease
• People with a severe skin infection (such as widespread infected skin sores or severe eczema)
• People who have taken part in another clinical drug trial within the 3 months before the skin test (certain exceptions may apply — confirm with trial site)
• People who have received an inactivated vaccine within 7 days before the skin test, or a live vaccine within 28 days before the skin test
• Women who are pregnant or breastfeeding, or women of childbearing age who test positive on a pregnancy test before joining
• People with a history of drug abuse
• People whose past medical history, physical examination results, or likelihood of not being able to follow the trial requirements the trial doctor believes could affect the trial results (for example, tattoos in the skin test area)

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