[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471161":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":40,"centralContacts":45,"locations":51,"responsibleParty":122,"collaborators":124,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":39,"eligibilityCriteria":137,"healthyVolunteers":133,"sex":138,"minAge":139,"maxAge":39,"enrollmentInfo":140,"targetDuration":39,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":54,"whyStopped":39,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Kirby Institute","OTHER_GOV",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 Arm A","ACTIVE_COMPARATOR","Immediate SARS-CoV-2 booster at week 0 and booster of combined diphtheria toxoid\u002Ftetanus toxoid (dT vaccine) at week 24.",[13,14],"Biological: diphtheria and tetanus toxoids (adsorbed) vaccine","Biological: COVID-19 vaccine",{"label":16,"type":10,"description":17,"interventionNames":18},"Group 1 Arm B","dT vaccine at week 0 and SARS-CoV-2 deferred booster at week 24.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Group 2 Arm C","Immediate SARS-CoV-2 booster at week 0.",[14],{"label":24,"type":10,"description":25,"interventionNames":26},"Group 2 Arm D","Delayed SARS-CoV-2 booster at week 24",[14],[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"BIOLOGICAL","diphtheria and tetanus toxoids (adsorbed) vaccine","The diphtheria\u002Ftetanus toxoids vaccine will be given to participants enrolled into Group 1 as a comparator vaccine to the mRNA COVID-19 booster vaccine with the aim of determining whether the results related to COVID-19 vaccine timing also apply to more traditional protein-based vaccines.",[9,16],[34],"ADT Booster",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"COVID-19 vaccine","All participants will receive a COVID-19 booster vaccination at either week 0 or week 24 depending on their randomised study arm",[9,16,20,24],null,[41],{"name":42,"affiliation":43,"role":44},"Sarah C Sasson, PhD","The Kirby Institute UNSW Sydney","PRINCIPAL_INVESTIGATOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":39,"email":50},"Dianne L Carey, PhD","CONTACT","+61 2 9385 0908","dcarey@kirby.unsw.edu.au",[52,70,83,96,109],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Blacktown Hospital","RECRUITING","Blacktown","New South Wales","2148","Australia","AU",{"type":61,"coordinates":62},"Point",[63,64],150.91667,-33.76667,{"lat":64,"lon":63},[67],{"name":68,"role":48,"phone":39,"phoneExt":39,"email":69},"Golo Ahlenstiel, MD-PhD","golo.ahlenstiel@health.nsw.gov.au",{"facility":71,"status":54,"city":72,"state":56,"zip":73,"country":58,"countryCode":59,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Royal Prince Alfred Hospital","Camperdown","2050",{"type":61,"coordinates":75},[76,77],151.17642,-33.88965,{"lat":77,"lon":76},[80],{"name":81,"role":48,"phone":39,"phoneExt":39,"email":82},"Frederick Lee, PhD","frederick.lee@health.nsw.gov.au",{"facility":84,"status":54,"city":85,"state":56,"zip":86,"country":58,"countryCode":59,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Concord General Repatriation Hospital","Concord","2137",{"type":61,"coordinates":88},[89,90],151.10381,-33.84722,{"lat":90,"lon":89},[93],{"name":94,"role":48,"phone":39,"phoneExt":39,"email":95},"Judith Trotman, MBChB","judith.trotman@health.nsw.gov.au",{"facility":97,"status":54,"city":98,"state":56,"zip":99,"country":58,"countryCode":59,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"St Vincent's Hospital, Sydney","Darlinghurst","2010",{"type":61,"coordinates":101},[102,103],151.21925,-33.87939,{"lat":103,"lon":102},[106],{"name":107,"role":48,"phone":39,"phoneExt":39,"email":108},"Anthony Kelleher, PhD","akelleher@kirby.unsw.edu.au",{"facility":110,"status":54,"city":111,"state":56,"zip":112,"country":58,"countryCode":59,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Westmead Hospital","Westmead","2145",{"type":61,"coordinates":114},[115,116],150.98768,-33.80383,{"lat":116,"lon":115},[119],{"name":120,"role":48,"phone":39,"phoneExt":39,"email":121},"Sarah Sasson, PhD","ssasson@kirby.unsw.edu.au",{"type":123,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[125,128],{"name":126,"class":127},"Seqirus Pty Ltd, Australia","UNKNOWN",{"name":129,"class":130},"Medical Research Future Fund","OTHER","100471161","phase-3-immunosuppression-and-covid-19-boosters-100471161",false,"NCT05415267","Immunosuppression and COVID-19 Boosters","Comparison of Immunity-boosting Regimens for COVID-19 Upon Initiation of Immunosuppressive Therapy","Inclusion Criteria:\n\n* Adult aged at least 18 years\n* Previously vaccinated with 2 (or more) doses of any licensed COVID-19 vaccine who requires initiation of moderate-to-severe immunosuppression; most recent COVID-19 vaccine dose must have been given \\> 3 months prior\n* Planned significant immunosuppressive therapy for at least 1 year\n* No cyclophosphamide, alemtuzumab or rituximab treatment in the past 5 years. Note: patient may have concurrent steroids with any treatments listed in protocol\n* Voluntarily given written informed consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Has underlying primary immunodeficiency\n* Has received or likely to receive intravenous\u002Fsubcutaneous immunoglobulin (IVIg\u002FScIg).\n* Projected treatment is likely to involve plasma exchange\n* Contraindication to receipt of SARS-CoV-2 vaccine\n* Intolerance of or previous allergic reaction to tetanus vaccination\n* Patients switching immunosuppressive therapies following enrolment with an absolute lymphocyte count \\<0.5 x 109\u002FL immediately prior to screening","ALL","18 Years",{"count":141,"type":142},320,"ESTIMATED","INTERVENTIONAL",[145],"PHASE3","It is important people receiving immunosuppressive therapy are provided with the best protection against COVID-19 because they are at greater risk of severe illness should they become infected. As severe immunosuppression can reduce the efficacy of COVID-19 vaccination, doctors agree that COVID-19 boosters is are important to maximise the vaccine response in these people. However, we don't currently know the best time to give booster vaccines to people about to start immunosuppressive therapy. This research aims to address this knowledge gap by examining whether the greatest protection is provided by giving the COVID-19 booster just before the immunosuppressive therapy starts or by waiting and giving the booster 6 months after treatment start. At the 6-month timepoint, in many cases the more intensive immunosuppression is often weaning and the immune system is starting to rebuild.",[148],"COVID-19",[150,151],"Vaccination","Immunology","2026-02-21",{"date":154,"type":155},"2026-02-24","ACTUAL",{"date":157,"type":155},"2023-07-21",{"date":159,"type":142},"2026-12-31",{"name":5,"class":6},5]