Phase 2 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:

• People aged 12 to 55 years old on the day they enroll.
• People who are able to attend a participating trial clinic and are willing to be followed for the full length of the study.
• People aged 18 and over who are able and willing to sign their own consent form agreeing to take part.
• People under 18 whose parent or legal guardian is willing and able to sign a consent form on their behalf; the young person themselves may also need to sign an agreement form depending on the ethics committee's rules.
• People who complete a short questionnaire before vaccination and can show they understand what the study involves.
• People who received the BCG vaccine as a baby, as confirmed by the trial site investigator.
• People who agree not to join another trial of an investigational product until after their last scheduled visit (if already in another trial, approval from that trial's sponsor and this trial's review team would be required).
• People who are in good general health, based on their medical history, a physical exam, and blood tests reviewed by the site investigator.
• People who are willing to receive their HIV test results.
• People who do not have HIV and have a negative HIV blood test, are assessed by clinic staff as having a low likelihood of getting HIV, and are willing to discuss HIV risk and receive counselling.
• People living with HIV who have completed one full course of tuberculosis (TB) preventive treatment, have had their HIV virus levels suppressed to very low levels (fewer than 50 copies per millilitre of blood) for at least 3 months before enrolling, and have been on HIV treatment (antiretroviral therapy/ART) for at least 6 months.
• People living with HIV joining one specific group (Cohort 2) who had mild HIV disease before starting ART and whose immune cell count (CD4) is at least 200 cells per cubic millimetre at screening.
• People living with HIV joining another specific group (Cohort 3) who had advanced HIV disease before starting ART and whose immune cell count (CD4) is now at least 100 cells per cubic millimetre at screening.
• People whose blood test results at screening are within acceptable ranges, including healthy levels of red blood cells, white blood cells, platelets, kidney function markers, and liver enzymes.
• People who test negative for Hepatitis B surface antigen.
• People who test negative for Hepatitis C, or who test negative on a follow-up Hepatitis C test if an initial screening test came back positive.
• People assigned female sex at birth or intersex at birth who could become pregnant, and who have a negative pregnancy test at screening and on the day the study product is given.
• People who could become pregnant and who agree to use effective contraception starting at least 21 days before enrolling until 10 weeks after vaccination, agree not to seek pregnancy through methods such as artificial insemination or IVF during that period, and agree not to undergo egg retrieval during that time.

Who may not be able to join:

• People who weigh less than 40 kilograms.
• People who have had a known significant close contact with someone who has active, untreated TB, or who have had a tuberculin skin test in the six months before enrolling.
• People who have a history of active TB disease.
• People who show signs of active TB disease based on their reported symptoms, a physical exam, chest X-ray, or laboratory testing; people living with HIV with a very low CD4 count who also have a positive urine TB test.
• People who have received TB preventive therapy within 28 days before enrolling, or who are expected to start TB preventive therapy during the study.
• People living with HIV who currently have an active AIDS-defining illness.
• People who have received blood products (such as a transfusion) within 120 days before vaccination.
• People who have received a non-vaccine investigational (experimental) product within 28 days before vaccination.
• People who are pregnant or breastfeeding.
• People who have previously received an investigational TB vaccine in a prior trial, or who received a BCG vaccine at any time other than in infancy (eligibility for people who received a placebo in a prior TB trial would be decided case by case by the trial review team).
• People who received an experimental non-TB vaccine within the past year in a prior trial (exceptions may be considered by the trial review team in some circumstances).
• People who received a live attenuated vaccine (such as MMR, chickenpox, yellow fever, or live flu vaccine) within 28 days before or scheduled within 28 days after the study injection.
• People who received any non-live vaccine (such as tetanus, pneumococcal, or Hepatitis A or B) within 14 days before the study injection.
• People who received allergy injection treatment within 28 days before vaccination or who have such treatment scheduled within 14 days after vaccination.
• People who have taken immune-suppressing medications within 168 days (about 5.5 months) before vaccination (certain low-dose or short-course steroid treatments may not be exclusionary — confirm with trial site).
• People who have had a serious allergic reaction (such as anaphylaxis, hives, breathing difficulty, or severe abdominal pain) to a vaccine or vaccine ingredient.
• People who have received immunoglobulin (antibody treatment) within 90 days before vaccination.
• People with a current or past autoimmune disease (mild, well-controlled psoriasis is not exclusionary).
• People with an immune deficiency condition other than HIV.
• People with a significant ongoing medical condition, abnormal physical exam findings, or abnormal lab results that could affect immune response, require immune-affecting medication, interfere with injections or blood draws, pose a serious health risk during the study, or whose symptoms could be confused with vaccine reactions.
• People with any medical, mental health, work-related, or other condition that the investigator believes would interfere with participation or safety, including significant substance use or alcohol use disorder.
• People with certain psychiatric conditions, specifically psychosis in the past 3 years, ongoing risk of suicide, or a history of suicide attempt or self-harm in the past 3 years.
• People with asthma that is not well controlled — specifically those who needed oral or injected steroids for an asthma attack two or more times in the past year, needed emergency or hospital care for asthma in the past year, use a rescue inhaler more than 2 days per week for symptoms, use medium-to-high-dose inhaled steroids, or use more than one daily maintenance medication (some exceptions may be considered by the trial review team).
• People with type 1 diabetes or type 2 diabetes that is not controlled by diet alone (a history of gestational diabetes alone is not exclusionary, provided blood sugar levels are confirmed to be in a healthy range at screening).
• People with high blood pressure that is not well controlled (confirm specific blood pressure thresholds with trial site).
• People with a bleeding disorder such as a clotting factor deficiency, a blood-clotting problem, or a platelet disorder that requires special precautions.
• People with a current cancer or malignancy (people who have had a cancer fully removed by surgery and are considered very unlikely to have it return during the study period may not be excluded — confirm with trial site).
• People who have had a seizure in the past 3 years, or who have taken seizure-prevention or seizure-treatment medication at any point in the past 3 years.
• People who do not have a functioning spleen, for any reason.
• People with a history of angioedema (severe swelling) or anaphylaxis (severe allergic reaction), unless the trigger is known and no episodes have occurred in the past five years.
• People who have had widespread hives (generalised urticaria) within the past five years.

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