[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100459767":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":35,"centralContacts":42,"locations":53,"responsibleParty":76,"collaborators":79,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":47,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":110,"overallStatus":56,"whyStopped":47,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Louisiana State University Health Sciences Center in New Orleans","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Gardasil-9 recipients","EXPERIMENTAL","Participants receive 3-dose Gardasil-9 vaccine series.",[13],"Biological: Human papillomavirus 9-valent vaccine, recombinant",{"label":15,"type":6,"description":16,"interventionNames":17},"Gardasil vaccine experienced cohort","Observational cohort to determine Gardasil HPV serum antibody titers in relation to time since vaccine series completion.",[18],"Biological: human papillomavirus vaccine, recombinant",[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Human papillomavirus 9-valent vaccine, recombinant","Subunit vaccine against 9 genotypes of human papillomavirus (6, 11, 16, 18, 31, 33, 45, 52, 58)",[9],[26,27],"Gardasil-9","Nonavalent HPV vaccine",{"type":21,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"human papillomavirus vaccine, recombinant","Subunit vaccine against four (6, 11, 16, 18) or nine (6, 11, 16, 18, 31, 33, 45, 52, 58) genotypes of human papillomavirus. Administered as part of participant's clinical care prior to study enrollment (intervention not delivered as part of study design).",[15],[33,34,26,27],"Gardasil-4","Quadrivalent HPV vaccine",[36,40],{"name":37,"affiliation":38,"role":39},"Jennifer E Cameron, PhD","Louisiana State University Health Sciences Center","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":38,"role":39},"Michael E Hagensee, MD, PhD",[43,49],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Vice Chancellor for Academic Affairs and Research","CONTACT","504-568-4804",null,"dporch@lsuhsc.edu",{"name":50,"role":45,"phone":51,"phoneExt":47,"email":52},"Executive Director, Office of Research Services","504-568-4985","jalam@lsuhsc.edu",[54],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"University Medical Center New Orleans","RECRUITING","New Orleans","Louisiana","70112","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-90.07507,29.95465,{"lat":66,"lon":65},[69,73,74],{"name":70,"role":45,"phone":71,"phoneExt":47,"email":72},"Jyotsna Fuloria","504-702-4900","Jyotsna.Fuloria@lcmchealth.org",{"name":37,"role":39,"phone":47,"phoneExt":47,"email":47},{"name":75,"role":39,"phone":47,"phoneExt":47,"email":47},"Michael E Hagensee, MD PhD",{"type":39,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"Jennifer Cameron","Assistant Professor",[80],{"name":81,"class":82},"Merck Sharp & Dohme LLC","INDUSTRY","100459767","phase-4-immunogenicity-of-gardasil-9-hpv-vaccine-in-people-living-with-hiv-100459767",false,"NCT05266898","Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV","Prospective Observational Immunogenicity Trial of Gardasil-9 HPV Vaccine in People Living With Adequately Managed HIV","AGO-Gard","Inclusion Criteria:\n\n* HIV seropositive\n* immune intact (CD4+ T cell count in peripheral blood \\>200 cells\u002Fml)\n* HIV controlled (peripheral blood HIV viral load \\\u003C1,000 genome copies\u002FmL)\n* Stable on antiretroviral regimen for ≥3 months\n* Gardasil-9 naive and age ≤45 OR\n* documented receipt of 3 doses of Gardasil-4 or Gardasil-9 HPV vaccine\n\nExclusion Criteria:\n\n* Medical contraindication for vaccination (vaccine-naive arm only)\n* Women who are pregnant\n* Acute illness\n* Taking chronic steroids, \\>0.5mg\u002Fkg prednisone or equivalent\n* Taking immune modulating medications\n* Received blood transfusion\u002Fblood products within the past 6 months\n* Recipients of other vaccine products within the past month\n* Inability to provide informed written consent",true,"ALL","18 Years","65 Years",{"count":96,"type":97},250,"ESTIMATED","INTERVENTIONAL",[100],"PHASE4","The primary objective of this study is to determine the magnitude and breadth of the serum antibody response to the nonavalent HPV vaccine (Gardasil-9) in adults with well-controlled HIV infection.\n\nThe secondary objectives of the study are to observe short term clinical outcomes of prevalent HPV genotype-specific anogenital infections in adults living with HIV who complete the three-dose Gardasil-9 vaccine series, and to determine the protection afforded by Gardasil vaccine over time in previously vaccinated adults living with HIV.\n\nThe clinical hypothesis is that adults with virologically controlled HIV mount a serum antibody response to the nonavalent HPV vaccine that is comparable to HIV negative counterparts. We also postulate that HPV vaccination will provide short-term clinical benefit against HPV infections and disease associated with vaccine genotypes and continuing protection against vaccine genotypes of HPV over time.",[103,104,105,106,107,108,109],"Papillomavirus Vaccines","Human Immunodeficiency Virus","Papillomavirus Infection","Serology","Cervical Intraepithelial Neoplasia","Anal Intraepithelial Neoplasia","Oral Cavity Infection",[111,112,113],"Gardasil-9 HPV vaccine","human papillomavirus","human immunodeficiency virus","2025-04-15",{"date":116,"type":117},"2025-04-18","ACTUAL",{"date":119,"type":117},"2022-11-30",{"date":121,"type":97},"2026-06",{"name":5,"class":6},1]