[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527458":3},{"organization":4,"armGroups":7,"interventions":47,"overallOfficials":80,"centralContacts":87,"locations":92,"responsibleParty":109,"collaborators":111,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":130,"sex":131,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":53,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":94,"whyStopped":53,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"South Australian Health and Medical Research Institute","OTHER",[8,18,22,26,30,35,39,43],{"label":9,"type":10,"description":11,"interventionNames":12},"Substudy 1 - BCG vaccine, antibiotics and 2nd BCG vaccine","EXPERIMENTAL","Randomised to receive antibiotics and a BCG vaccine at visit 1 and a second BCG vaccine 6 months later",[13,14,15,16,17],"Biological: BCG vaccine","Drug: Vancomycin Oral Capsule","Drug: Neomycin Oral Product","Drug: Metoclopramide (Maxolon)","Drug: Loperamide HCl",{"label":19,"type":10,"description":20,"interventionNames":21},"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",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"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",[13,14,15,16,17],{"label":27,"type":10,"description":28,"interventionNames":29},"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",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"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",[13,34,14,15,16,17],"Biological: Yellow Fever vaccine",{"label":36,"type":10,"description":37,"interventionNames":38},"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",[13,34],{"label":40,"type":10,"description":41,"interventionNames":42},"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",[34,14,15,16,17],{"label":44,"type":10,"description":45,"interventionNames":46},"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",[34],[48,54,58,66,72,76],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"BIOLOGICAL","BCG vaccine","0.1ml injected intradermally over the distal insertion of the deltoid muscle onto the humerus",[9,23,19,27,31,36],null,{"type":49,"name":55,"description":56,"armGroupLabels":57,"otherNames":53},"Yellow Fever vaccine","0.5ml injected subcutaneously",[31,40,36,44],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"DRUG","Vancomycin Oral Capsule","500mg every 6 hours for 3 days",[9,23,31,40],[64,65],"Firvanq","Vancocin HCl Pulvules",{"type":59,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"Neomycin Oral Product","1000mg every 6 hours for 3 days",[9,23,31,40],[71],"Neo-Fradin",{"type":59,"name":73,"description":74,"armGroupLabels":75,"otherNames":53},"Metoclopramide (Maxolon)","10mg every 8 hours",[9,23,31,40],{"type":59,"name":77,"description":78,"armGroupLabels":79,"otherNames":53},"Loperamide HCl","2mg tablets\u002Fcapsules: 2 tablets\u002Fcapsules initially, followed by 1 tablet after each loose motion, to a maximum of 8 tablets\u002Fcapsules per day",[9,23,31,40],[81,85],{"name":82,"affiliation":83,"role":84},"Simone Barry","Royal Adelaide Hospital","PRINCIPAL_INVESTIGATOR",{"name":86,"affiliation":5,"role":84},"David Lynn",[88],{"name":86,"role":89,"phone":90,"phoneExt":53,"email":91},"CONTACT","+61 8 8128 4053","david.lynn@sahmri.com",[93],{"facility":5,"status":94,"city":95,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"RECRUITING","Adelaide","South Australia","5000","Australia","AU",{"type":101,"coordinates":102},"Point",[103,104],138.59863,-34.92866,{"lat":104,"lon":103},[107,108],{"name":86,"role":89,"phone":90,"phoneExt":53,"email":91},{"name":86,"role":84,"phone":53,"phoneExt":53,"email":53},{"type":84,"investigatorFullName":86,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"Director, Computational & Systems Biology Program",[112,113,115,117,119],{"name":83,"class":6},{"name":114,"class":6},"Flinders University",{"name":116,"class":6},"University of Sydney",{"name":118,"class":6},"Telethon Kids Institute",{"name":120,"class":121},"Centenary Institute","UNKNOWN","100527458","phase-4-antibiotics-and-vaccine-immune-responses-study-100527458",false,"NCT06148025","Antibiotics and Vaccine Immune Responses Study","A Human Experimental Medicine Study to Assess Whether the Gut Microbiota Regulates Specific and Non-specific Immune Responses to Vaccination","AVIRS","Inclusion Criteria:\n\n* 18-35 years old\n* Provided a signed and dated informed consent form\n* BCG naïve (Arm 1) and BCG and YF vaccine naïve (Arm 2)\n* Willing to take short antibiotic course\n* Willing to undergo a punch biopsy (Arm 1)\n* Willing to have up to 7 blood samples and 3 stool samples collected over 5-7 months\n* Not pregnant or intending to get pregnant for the duration of the study (a pregnancy test will be offered to females)\n\nExclusion Criteria:\n\n* Previous BCG or YF vaccination\n* Previous YF infection\n* Evidence of latent TB infection (LTBI) (assessed through a questionnaire) (IGRA to confirm if needed)\n* People with contraindications for BCG vaccination:\n\n  * malignancies involving bone marrow or lymphoid systems, primary or secondary immunodeficiencies, HIV infection\n  * moderate\u002Fsevere skin disease including eczema, dermatitis or psoriasis\n  * 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)\n* People with contraindications to YF vaccination:\n\n  * History of thymus disease, including myasthenia gravis, thymoma, thymectomy, DiGeorge syndrome, thymic damage from chemoradiotherapy or graft-versus-host disease\n  * 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\n  * People who have had a haematopoietic stem cell transplant\n  * Individuals with history of severe allergic reactions to egg or chicken proteins\n* Pregnant or breastfeeding or planning to become pregnant\n* History of renal disease\u002Finsufficiency\n* Tattoo obscuring BCG vaccination site(s)\n* Any history of severe allergic reaction or anaphylaxis to vaccination or antibiotics\n* People with chronic serious underlying illness\n* 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)",true,"ALL","18 Years","35 Years",{"count":135,"type":136},348,"ESTIMATED","INTERVENTIONAL",[139],"PHASE4","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.\n\nThe 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?",[142],"Vaccine Response Impaired",[144,145,50,55,146],"Healthy participants","18-35 years old","Antibiotics","2025-12-03",{"date":149,"type":150},"2025-12-10","ACTUAL",{"date":152,"type":150},"2023-11-23",{"date":154,"type":136},"2028-10-01",{"name":5,"class":6},1]