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 who are between 14 and 45 years old on the first day of the study
• People who have signed the required consent forms (or, for those under 18, whose parent or guardian has given written consent and the young person has also agreed to participate)
• People who, in the opinion of the research team, are able and willing to follow the study requirements, such as staying in contact with the research centre and attending follow-up visits
• People who are in generally good health, based on their medical history and a physical check-up
• People born female who could become pregnant must agree to use an accepted form of contraception from 21 days before the study starts until 2 months after vaccination. Accepted methods include condoms (male or female) with or without spermicide, a diaphragm or cervical cap with spermicide, an intrauterine device (IUD), hormonal contraception (such as the pill, implant, or injection), a male partner who has had a confirmed successful vasectomy, not being able to become pregnant for medical or surgical reasons, or not having any heterosexual sexual activity
• People born male must agree to use barrier contraception (such as condoms) with female partners for at least 2 weeks after vaccination
• People who have not shared a living space overnight, or for frequent or extended periods during the day, with someone diagnosed with tuberculosis (TB) in the 6 months before the study starts
• People who test negative for HIV at the screening stage
• People who have a negative TB symptom screening questionnaire and a negative sputum test for active TB lung disease at screening

Who may not be able to join:

• People who are acutely unwell or have an armpit temperature of 37.5°C or higher on the first day of the study
• People where there is any current suspicion or evidence of active TB disease at the time of screening
• People who have previously had TB disease or received treatment for TB disease
• People who have previously taken medication to prevent TB (not including the BCG vaccine)
• People who have received any experimental drug or vaccine within the 42 days before the study starts, or who plan to do so during the study
• People who have received, or plan to receive, a licensed (approved) vaccine not part of this study in the period starting 28 days before the study begins and ending 28 days after the study vaccination
• People who have previously received any experimental TB vaccine (note: people who received a placebo in a previous TB vaccine trial may still be considered, with proper documentation and approval from the medical monitor — confirm with trial site)
• People who have regularly taken immune-suppressing medication in the 42 days before the study starts (inhaled and skin-applied corticosteroids are generally allowed — confirm with trial site)
• People who have, or are suspected of having, any condition that weakens or suppresses the immune system, or any autoimmune condition, based on medical history and physical examination
• People who are currently participating in, or plan to participate in, another experimental study during the trial period (taking part in an observational study that does not involve collecting blood or tissue samples is generally not an exclusion — confirm with trial site)
• People who have received immunoglobulin or blood products within 42 days before the study starts, or who plan to do so during the study
• People with a history of allergic reactions or sensitivities that may be triggered by any ingredient in the vaccines used in this study
• People who are pregnant, currently breastfeeding, or who return a positive pregnancy test at screening or on the first day of the study
• People whose IGRA test result (a blood test used to check for TB exposure) comes back as indeterminate (unclear) at screening
• People who, in the opinion of the research team, have current or past medical, mental health, work-related, or substance use issues that could affect their safety or their ability to follow the study requirements

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