Actively Recruiting
Antibiotics and Vaccine Immune Responses Study
Led by South Australian Health and Medical Research Institute · Updated on 2025-12-10
348
Participants Needed
1
Research Sites
253 weeks
Total Duration
On this page
Sponsors
S
South Australian Health and Medical Research Institute
Lead Sponsor
R
Royal Adelaide Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
Antibiotics and Vaccine Immune Responses Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 35 years old
- Provided signed and dated informed consent
- Have never received BCG vaccine (for Arm 1)
- Have never received BCG or Yellow Fever vaccine (for Arm 2)
- Willing to take a short course of antibiotics
- Willing to undergo a punch biopsy if in Arm 1
- Willing to have up to 7 blood samples and 3 stool samples collected over 5 to 7 months
- Not pregnant and not planning to become pregnant during the study
You will not qualify if you...
- Previous BCG or Yellow Fever vaccination
- Previous Yellow Fever infection
- Signs of latent tuberculosis infection
- Conditions preventing BCG vaccination such as bone marrow or immune system cancers, immune deficiencies, HIV infection, moderate to severe skin diseases, or use of immune-suppressing drugs
- Conditions preventing Yellow Fever vaccination including thymus diseases, immunocompromised status, previous stem cell transplant, or severe allergy to egg or chicken proteins
- Pregnant, breastfeeding, or planning pregnancy
- History of kidney disease or insufficiency
- Tattoos covering the BCG vaccination site
- History of severe allergic reactions or anaphylaxis to vaccines or antibiotics
- Chronic serious illness
- Use of certain prescribed antibiotics in the 28 days before study visits 1 and 4
AI-Screening
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Trial Site Locations
Total: 1 location
1
South Australian Health and Medical Research Institute
Adelaide, South Australia, Australia, 5000
Actively Recruiting
Research Team
D
David Lynn
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
8
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