Aerosol BCG Challenge Study in Historically BCG-vaccinated Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Tuberculosis
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: This is a phase I dose-escalation clinical challenge study in historically BCG-vaccinated healthy adult volunteers in which BCG will be administered via the aerosol inhaled route. There will be four study groups with three volunteers in each group. Volunteers will be sequentially enrolled into each group in turn based on their availability. The first participant will be challenged in each group individually. After a 14 day follow up period, there will be an interim safety review. If considered safe to do so by the chief investigator, the two remaining participants in each group will be challenged. A further 14 day follow up period will occur followed by an SMC safety review. Dose escalation into the next group will only occur if there are no safety concerns.Masking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 50 years
- Gender
- Both males and females
Description
Tuberculosis (TB) is responsible for more deaths worldwide than any infectious disease. Key research priorities include the development of an effective vaccine. Currently, the only licensed vaccine against TB is the BCG (Bacille Calmette-Guérin). This works well against TB in childhood but is often ...
Tuberculosis (TB) is responsible for more deaths worldwide than any infectious disease. Key research priorities include the development of an effective vaccine. Currently, the only licensed vaccine against TB is the BCG (Bacille Calmette-Guérin). This works well against TB in childhood but is often ineffective in adults. Developing a new TB vaccine is difficult, as it is hard to determine which will be effective. In other diseases, e.g. influenza or malaria, it is possible to experimentally-infect volunteers with the disease to see if the proposed vaccine is effective. This is called a "controlled human challenge or infection model" and is possible in easily treatable or self-limiting diseases. This is not possible with TB, where treatments may be harmful and complex. Using a related but less infectious bacterium is a feasible alternative. The BCG is a live attenuated (weakened) strain of the bacteria that causes TB in cattle. The BCG bacteria do not cause disease in healthy individuals. As the BCG and TB bacteria are similar, a challenge model using the BCG as an infectious agent to mimic TB infection is being developed. Mycobacterium tuberculosis, the bacterium that causes TB, infects people by inhalation into the lungs. Therefore, inhaled BCG more closely imitates TB infection than an injection. A previous (TB041) and current study (TB043) in this group use aerosol inhaled BCG in volunteers who have not received the standard BCG vaccination before. The purpose of this study is to evaluate the human clinical response to BCG challenge in historically BCG-vaccinated healthy adult volunteers. It will involve 12 participants in a controlled dose escalation. Bronchoscopies will be performed 14 days post-challenge to measure BCG recovered from bronchial samples. Blood tests will be taken to look at potential immunological markers of immunity.
Tracking Information
- NCT #
- NCT04777721
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Helen McShane, Professor University of Oxford
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