[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oral-cavity-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oral-cavity-infection":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":36,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":5},"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":22,"type":23},250,"ESTIMATED","INTERVENTIONAL",[26],"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.",[29,30,31,32,33,34,35],"Papillomavirus Vaccines","Human Immunodeficiency Virus","Papillomavirus Infection","Serology","Cervical Intraepithelial Neoplasia","Anal Intraepithelial Neoplasia","Oral Cavity Infection",[37,38,39],"Gardasil-9 HPV vaccine","human papillomavirus","human immunodeficiency virus","RECRUITING","2025-04-15",{"date":43,"type":44},"2025-04-18","ACTUAL",{"date":46,"type":44},"2022-11-30",{"date":48,"type":23},"2026-06",{"name":50,"class":51},"Louisiana State University Health Sciences Center in New Orleans","OTHER"]