Antibiotics and Vaccine Immune Responses Study
The goal of this clinical trial is to examine immune responses to the BCG vaccine in healthy adults who have, or who have not, taken antibiotics to deplete their gut bacteria prior to vaccination. The main question it aims to answer is: does depletion of the gut microbiota lead to impaired BCG-induced protection agains
| Condition(s) | Vaccine Response Impaired |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | The goal of this clinical trial is to examine immune responses to the BCG vaccine in healthy adults who have, or who have not, taken antibiotics to deplete their gut bacteria prior to vaccination. The main question it aims to answer is: does depletion of the gut microbiota lead to impaired BCG-induced protection against specific and non-specific to challenges to the immune system? |
| Who can participate | Inclusion Criteria: * 18-35 years old * Provided a signed and dated informed consent form * BCG naïve (Arm 1) and BCG and YF vaccine naïve (Arm 2) * Willing to take short antibiotic course * Willing to undergo a punch biopsy (Arm 1) * Willing to have up to 7 blood samples and 3 stool samples collected over 5-7 months * Not pregnant or intending to get pregnant for the duration of the study (a pregnancy test will be offered to females) Exclusion Criteria: * Previous BCG or YF vaccination * Previous YF infection * Evidence of latent TB infection (LTBI) (assessed through a questionnaire) (IGRA to confirm if needed) * People with contraindications for BCG vaccination: * malignancies involving bone marrow or lymphoid systems, primary or secondary immunodeficiencies, HIV infection * moderate/sev |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | South Australian Health and Medical Research Institute |
| Locations | Adelaide, South Australia, Australia |
| Start date | 2023-11-23 |
| NCT ID | NCT06148025 |
| Official listing | https://clinicaltrials.gov/study/NCT06148025 |