Status:
RECRUITING
Antibiotics and Vaccine Immune Responses Study
Lead Sponsor:
South Australian Health and Medical Research Institute
Collaborating Sponsors:
Royal Adelaide Hospital
Flinders University
Conditions:
Vaccine Response Impaired
Eligibility:
All Genders
18-35 years
Phase:
PHASE4
Brief 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. Th...
Detailed Description
The study is divided into two sub-studies. The first sub-study (BCG re-challenge) is an experimental medicine study in 168 healthy participants to determine if depletion of the gut microbiota leads to...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT06148025
Start Date
November 23 2023
End Date
October 1 2028
Last Update
December 10 2025
Active Locations (1)
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1
South Australian Health and Medical Research Institute
Adelaide, South Australia, Australia, 5000