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New treatment option for Vaccine Response Impaired
Official title Antibiotics and Vaccine Immune Responses Study
ClinicalTrials.gov ID: NCT06148025
What this study is testing
What is BCG vaccine?
BCG vaccine is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for vaccine response impaired.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 35. Healthy volunteers may be eligible.
You may be able to join 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)
You likely can't join 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
See the full eligibility 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)
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Adelaide, South Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 35 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Adelaide, South Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.