NCT06148025 Antibiotics and Vaccine Immune Responses Study
| NCT ID | NCT06148025 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | South Australian Health and Medical Research Institute |
| Condition | Vaccine Response Impaired |
| Study Type | INTERVENTIONAL |
| Enrollment | 348 participants |
| Start Date | 2023-11-23 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 348 participants in total. It began in 2023-11-23 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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?
Eligibility Criteria
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
Contact & Investigator
David Lynn
PRINCIPAL INVESTIGATOR
South Australian Health and Medical Research Institute
Frequently Asked Questions
Who can join the NCT06148025 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 35 Years, studying Vaccine Response Impaired. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06148025 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06148025 currently recruiting?
Yes, NCT06148025 is actively recruiting participants. Contact the research team at david.lynn@sahmri.com for enrollment information.
Where is the NCT06148025 trial being conducted?
This trial is being conducted at Adelaide, Australia.
Who is sponsoring the NCT06148025 clinical trial?
NCT06148025 is sponsored by South Australian Health and Medical Research Institute. The principal investigator is David Lynn at South Australian Health and Medical Research Institute. The trial plans to enroll 348 participants.