Antibiotics and Vaccine Immune Responses Study
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Vaccine Response Impaired
In brief
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?
Key facts
- Study ID
- NCT06148025
- Run by
- South Australian Health and Medical Research Institute
- People needed
- 348
- Starts
- 2023-11-23
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2025-12-10
Who can join
Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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/severe skin disease including eczema, dermatitis or psoriasis
- requiring immunosuppressive drugs or other immune modifying drugs e.g. corticosteroids, non-biological immunosuppressants, biological agents (such as monoclonal antibodies against tumour necrosis factor (TNF)-alpha)
- People with contraindications to YF vaccination:
- History of thymus disease, including myasthenia gravis, thymoma, thymectomy, DiGeorge syndrome, thymic damage from chemoradiotherapy or graft-versus-host disease
- YF vaccination is contraindicated in immunocompromised individuals, including individuals who have HIV infection, primary immunodeficiencies (including inherited IFNAR1 deficiency), or are taking corticosteroids or other immunosuppressive agents and haematopoietic stem cell transplant recipients
- People who have had a haematopoietic stem cell transplant
- Individuals with history of severe allergic reactions to egg or chicken proteins
- Pregnant or breastfeeding or planning to become pregnant
- History of renal disease/insufficiency
- Tattoo obscuring BCG vaccination site(s)
- Any history of severe allergic reaction or anaphylaxis to vaccination or antibiotics
- People with chronic serious underlying illness
- Have received any prescribed oral or intravenous antibiotic in the 28 days prior to study visits 1 and 4 (including isoniazid, rifampicin, streptomycin and ethambutol as these particular antibiotics have activity against M. bovis)
Where it is running
- South Australian Health and Medical Research Institute — Adelaide, South Australia, Australia (enrolling)
Full record on ClinicalTrials.gov
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