Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
348 participants
INTERVENTIONAL
2023-11-23
2028-10-01
Brief Summary
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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?
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Detailed Description
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The second sub-study (Yellow Fever vaccine) has a very similar experimental design to the first but will determine if depletion of the gut microbiota leads to impaired BCG-induced protection against other infections. To assess this, participants in this sub-study (n=180) will be re-challenged after 3 months with a live attenuated viral vaccine, the Yellow Fever vaccine, which induces a mild viremia.
In both sub-studies, participants will initially be randomised to receive a 3 day course of antibiotics or none (comparator group). The two groups in each sub-study will be randomised again to receive either BCG vaccine or 0.9% NaCl placebo injection in the left arm.
BCG re-challenge sub-study (Sub-study 1): Six months following randomisation, all participants will receive a BCG vaccine challenge in the right arm. A punch skin biopsy will be taken of this challenge site 2 weeks after the challenge to assess M. bovis BCG bacterial load in the skin.
Yellow Fever vaccine sub-study (Sub-study 2): Three months following randomisation, all participants will receive a Yellow Fever vaccine challenge in the right arm. Blood samples will be collected from Yellow Fever vaccinated participants at day 3, 5 and 7 following Yellow Fever vaccine challenge to quantify Yellow Fever viral load in blood.
All participants in both sub-studies will have blood samples collected at randomisation, before each vaccination, 2 weeks after each BCG vaccination and in the Yellow Fever vaccine sub-study at day 3, 5 and 7 following Yellow Fever vaccination. Stool samples will be collected prior to randomisation, and prior to each vaccination.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* antibiotics or comparator (unblinded) and
* BCG vaccine or placebo (blinded)
* BCG vaccine or Yellow Fever vaccine (unblinded)
BASIC_SCIENCE
DOUBLE
Study Groups
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Substudy 2 - Yellow Fever vaccine, antibiotics and placebo vaccine
Randomised to receive antibiotics, a placebo vaccine at visit 1 and a Yellow Fever vaccine 3 months later
Yellow Fever vaccine
0.5ml injected subcutaneously
Vancomycin Oral Capsule
500mg every 6 hours for 3 days
Neomycin Oral Product
1000mg every 6 hours for 3 days
Metoclopramide (Maxolon)
10mg every 8 hours
Loperamide HCl
2mg tablets/capsules: 2 tablets/capsules initially, followed by 1 tablet after each loose motion, to a maximum of 8 tablets/capsules per day
Substudy 2 - Yellow Fever vaccine, no antibiotics and placebo vaccine
Randomised to receive no antibiotics, a placebo vaccine at visit 1 and a Yellow Fever vaccine 3 months later
Yellow Fever vaccine
0.5ml injected subcutaneously
Substudy 1 - BCG vaccine, antibiotics and 2nd BCG vaccine
Randomised to receive antibiotics and a BCG vaccine at visit 1 and a second BCG vaccine 6 months later
BCG vaccine
0.1ml injected intradermally over the distal insertion of the deltoid muscle onto the humerus
Vancomycin Oral Capsule
500mg every 6 hours for 3 days
Neomycin Oral Product
1000mg every 6 hours for 3 days
Metoclopramide (Maxolon)
10mg every 8 hours
Loperamide HCl
2mg tablets/capsules: 2 tablets/capsules initially, followed by 1 tablet after each loose motion, to a maximum of 8 tablets/capsules per day
Substudy 1 - BCG vaccine, no antibiotics and 2nd BCG vaccine
Randomised to receive no antibiotics and a BCG vaccine at visit 1 and a second BCG vaccine 6 months later
BCG vaccine
0.1ml injected intradermally over the distal insertion of the deltoid muscle onto the humerus
Substudy 1 - BCG vaccine, antibiotics and placebo vaccine
Randomised to receive antibiotics, a placebo vaccine at visit 1 and a BCG vaccine 6 months later
BCG vaccine
0.1ml injected intradermally over the distal insertion of the deltoid muscle onto the humerus
Vancomycin Oral Capsule
500mg every 6 hours for 3 days
Neomycin Oral Product
1000mg every 6 hours for 3 days
Metoclopramide (Maxolon)
10mg every 8 hours
Loperamide HCl
2mg tablets/capsules: 2 tablets/capsules initially, followed by 1 tablet after each loose motion, to a maximum of 8 tablets/capsules per day
Substudy 1 - BCG vaccine, no antibiotics and placebo vaccine
Randomised to receive no antibiotics, a placebo vaccine at visit 1 and a BCG vaccine 6 months later
BCG vaccine
0.1ml injected intradermally over the distal insertion of the deltoid muscle onto the humerus
Substudy 2 - Yellow Fever vaccine, antibiotics and BCG vaccine
Randomised to receive antibiotics, a BCG vaccine at visit 1 and a Yellow Fever vaccine 3 months later
BCG vaccine
0.1ml injected intradermally over the distal insertion of the deltoid muscle onto the humerus
Yellow Fever vaccine
0.5ml injected subcutaneously
Vancomycin Oral Capsule
500mg every 6 hours for 3 days
Neomycin Oral Product
1000mg every 6 hours for 3 days
Metoclopramide (Maxolon)
10mg every 8 hours
Loperamide HCl
2mg tablets/capsules: 2 tablets/capsules initially, followed by 1 tablet after each loose motion, to a maximum of 8 tablets/capsules per day
Substudy 2 - Yellow Fever vaccine, no antibiotics and BCG vaccine
Randomised to receive no antibiotics, a BCG vaccine at visit 1 and a Yellow Fever vaccine 3 months later
BCG vaccine
0.1ml injected intradermally over the distal insertion of the deltoid muscle onto the humerus
Yellow Fever vaccine
0.5ml injected subcutaneously
Interventions
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BCG vaccine
0.1ml injected intradermally over the distal insertion of the deltoid muscle onto the humerus
Yellow Fever vaccine
0.5ml injected subcutaneously
Vancomycin Oral Capsule
500mg every 6 hours for 3 days
Neomycin Oral Product
1000mg every 6 hours for 3 days
Metoclopramide (Maxolon)
10mg every 8 hours
Loperamide HCl
2mg tablets/capsules: 2 tablets/capsules initially, followed by 1 tablet after each loose motion, to a maximum of 8 tablets/capsules per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
35 Years
ALL
Yes
Sponsors
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Royal Adelaide Hospital
OTHER
Flinders University
OTHER
University of Sydney
OTHER
Telethon Kids Institute
OTHER
Centenary Institute
UNKNOWN
South Australian Health and Medical Research Institute
OTHER
Responsible Party
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David Lynn
Director, Computational & Systems Biology Program
Principal Investigators
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Simone Barry
Role: PRINCIPAL_INVESTIGATOR
Royal Adelaide Hospital
David Lynn
Role: PRINCIPAL_INVESTIGATOR
South Australian Health and Medical Research Institute
Locations
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South Australian Health and Medical Research Institute
Adelaide, South Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023/HREC00066
Identifier Type: -
Identifier Source: org_study_id
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