drugset / Trial / NCT06148025
Antibiotics and Vaccine Immune Responses Study
Phase 4
Recruiting
348 enrolled
South Australian Health and Medical Research Institute
Centenary Institute · collabFlinders University · collabRoyal Adelaide Hospital · collabTelethon Kids Institute · collabUniversity of Sydney · collab
RandomizedParallel-groupDouble-blindBasic science
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?
Timeline
- Start
- 2023-11-23
- Primary completion
- 2027-10-01
- Completion
- 2028-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BCG vaccine | Vaccine | 0.1 ml | Other |
| Subject | Neomycin | Unknown | 1000 mg | Oral |
| Subject | Vancomycin | Other / unclassified | 500 mg | Oral |
| Subject | Yellow Fever Vaccine | Vaccine | 0.5 ml | Subcutaneous |
| Background | Loperamide | Small molecule | 2 mg | — |
| Background | Metoclopramide | Small molecule | 10 mg | — |
Indications
No indication recorded.