Antibiotics before vaccination? study tests gut Bacteria's role
NCT ID NCT06148025
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times
Summary
This study looks at whether taking antibiotics to reduce gut bacteria changes how well the BCG vaccine works. Healthy adults aged 18-35 will either take antibiotics or not before getting the vaccine. Researchers will then measure immune responses to see if gut bacteria are important for vaccine protection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 348 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 35 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 vaccination * Previous YF vaccination or YFV infection (only applies to participants included in the Yellow Fever Vaccine challenge sub-study) * Evidence of TB infection (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) * Have received any vaccinations in the 28 days prior to study visits 1 and 4
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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South Australian Health and Medical Research Institute
RECRUITINGAdelaide, South Australia, 5000, Australia
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