[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vaccine-response-impaired\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vaccine-response-impaired":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100536280","safety-and-immunogenicity-of-recombinant-zoster-vaccine-for-transplant-recipients-100536280",false,"NCT06262776","Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients","Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients (SIR ZOSTER)","SIR ZOSTER","1. Population - Group 1. Healthy co-habitants (n = 30)\n\n   Inclusion criteria:\n   * Household co-habitant of transplant recipient in trial\n   * Aged \\>50 years\n   * Previous documented infection with VZV (known infection history or positive VZV IgG result)\n\n   Exclusion criteria:\n   * Aged \\\u003C50 years\n   * Unable or unwilling to provide informed consent to participate in the trial\n   * Known allergy to or intolerance of the contents of the RZV vaccine\n   * No previous infection with VZV (chickenpox)\n   * History of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy\n2. Population - Groups 2-4. Transplant recipients (n = 90)\n\n   Inclusion criteria:\n   * Organ transplant recipients\n\n     \\-- Specific immunosuppression regimen\n     * Tacrolimus, mycophenolate, prednisolone (n = 30, Group 2)\n     * Tacrolimus, mTORi, prednisolone (n = 30, Group 3)\n     * mTORi, mycophenolate, prednisolone (n = 30, Group 4)\n   * Aged \\>18 years\n   * estimated GFR \\> 15 mL\u002Fmin\u002F1.73m2\n   * Previous documented infection with VZV (known infection history or positive VZV IgG result)\n\n   Exclusion criteria:\n   * Aged \\\u003C18 years\n   * Unable or unwilling to provide informed consent to participate in the trial\n   * No previous infection with VZV (chickenpox)\n   * Known allergy to or intolerance of the contents of the RZV vaccine\n   * Current pregnancy\n3. Population - Group 5. Other (n = 10)\n\n   Inclusion criteria:\n   * Immunosuppressed patient receiving single-agent rapamycin immunosuppression\n   * Aged \\>18 years\n   * Previous documented infection with VZV (known infection history or positive VZV IgG result)\n\n   Exclusion criteria:\n   * Aged \\\u003C18 years\n   * Unable or unwilling to provide informed consent to participate in the trial\n   * Known allergy to or intolerance of the contents of the RZV vaccine\n   * No previous infection with VZV (chickenpox)\n   * Known allergy to or intolerance of the contents of the RZV vaccine\n   * Current pregnancy\n   * History of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy\n4. Population - Group 6. Dialysis group (n = 30)\n\nInclusion criteria:\n\n* Kidney failure receiving haemodialysis as kidney replacement therapy\n* Aged \\>18 years\n* Previous documented infection with VZV (known infection history or positive VZV IgG result)\n\nExclusion criteria:\n\n* Aged \\\u003C18 years\n* Unable or unwilling to provide informed consent to participate in the trial\n* Known allergy to or intolerance of the contents of the RZV vaccine\n* No previous infection with VZV (chickenpox)\n* Known allergy to or intolerance of the contents of the RZV vaccine\n* Current pregnancy\n* History of primary immunodeficiency or active immunosuppressive therapy","ALL","18 Years",{"count":20,"type":21},160,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between transplant patients on different medication regimens, and their healthy co-habitants. The main questions it aims to answer are:\n\n1. Are there differences in vaccination immunological responses in transplant patients on different immunosuppression regimens?\n2. Are there differences in vaccination immunological responses between transplant patients and their healthy co-habitants? Participants will all receive a 2-dose course of SHINGRIX recombinant Zoster vaccination, and have immunological responses measured and compared at 5 timepoints between 1 week to 1 year post-vaccination.",[27,28],"Immunosuppression","Vaccine Response Impaired","RECRUITING","2026-04-06",{"date":32,"type":33},"2026-04-09","ACTUAL",{"date":35,"type":33},"2024-03-20",{"date":37,"type":21},"2027-12",{"name":39,"class":40},"Central Adelaide Local Health Network Incorporated","OTHER_GOV",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":41},"100510248","is-a-third-dose-of-mmrv-vaccine-beneficial-for-the-adult-population-in-alberta-100510248","NCT05923970","Is a Third Dose of MMRV Vaccine Beneficial for the Adult Population in Alberta?","Is a Third Dose of Measles-mumps-rubella-(Varicella) Vaccine (MMR(V)) Vaccine Beneficial for the Adult Population in Alberta?","Inclusion Criteria:\n\n* Women who are pregnant and have undergone routine prenatal screening for rubella antibodies.\n\nExclusion Criteria:\n\n* Women younger than 18 years of age","FEMALE",{"count":51,"type":21},200,"OBSERVATIONAL","The current recommendation for a full course of measles-mumps-rubella-(varicella) vaccine (MMR(V)) is two doses. The problem is, many individuals within the vaccinated cohort show antibody levels that are below the level considered to be protective, even after two doses of vaccine. Because of these waning antibody levels, it is currently unknown whether highly vaccinated populations are protected from infection against measles, mumps, rubella, or varicella should they be exposed to any of these viruses. The uncertainty of a woman's immune status is partly due to the type of testing that is used to indicate protection. While immunity to viral infection requires both a humoral and a cell mediated immune (CMI) response, only humoral (antibody) responses are measured routinely in the laboratory. This study will examine CMI responses and the role of a third dose of vaccine for previously vaccinated women whose antibody levels are below the cut off. This study will not administer vaccine, but rather will include women who have received a third dose of vaccination through routine health care follow up in the study cohort.",[55,28],"Vaccination Failure","2026-03-12",{"date":58,"type":33},"2026-03-16",{"date":60,"type":33},"2024-11-09",{"date":62,"type":21},"2027-09-30",{"name":64,"class":65},"University of Alberta","OTHER",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":41},"100527458","phase-4-antibiotics-and-vaccine-immune-responses-study-100527458","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,"35 Years",{"count":77,"type":21},348,[79],"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?",[28],[83,84,85,86,87],"Healthy participants","18-35 years old","BCG vaccine","Yellow Fever vaccine","Antibiotics","2025-12-03",{"date":90,"type":33},"2025-12-10",{"date":92,"type":33},"2023-11-23",{"date":94,"type":21},"2028-10-01",{"name":96,"class":65},"South Australian Health and Medical Research Institute"]