[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568469":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":41,"studyPopulation":30,"armGroups":42,"interventions":58,"overallOfficials":66,"centralContacts":75,"locations":83,"responsibleParty":133,"collaborators":136,"id":144,"slug":30,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":151,"sex":152,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":30,"studyType":158,"phases":159,"briefSummary":161,"conditions":162,"keywords":167,"overallStatus":176,"whyStopped":30,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},{"fullName":5,"class":6},"National Institute of Hygiene and Epidemiology, Vietnam","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Comparison between antibody responses after the 3rd dose ofregular vaccine schedules among FSW and after the 2nd dose of the extended schedule","geometric mean titer (GMT) ratios and 95% confidence intervals (CI) of HPV- specific antibody responses to HPV16 and HPV18 at 7m between FSWs aged 18-26 years who received either the standard (0, 2m, 6m) or extended 3-dose (at 0, 6m and 18m) 3-dose 9vHPV schedule and age-matched non-FSWs who received the extended 3-dose 9vHPV schedule (at 0, 6m and 18m).","7 months from the first doses",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"Comparison of antibody responses after each doses among FSW according to HPV infection status pre-vaccination","Antibody GMT at 2m, 7m, 18m and 19m between FSW who are HPV DNA+\u002Fseropositive with FSW who are HPV DNA-\u002Fseronegative at baseline.","19 months after the 1st doses",{"measure":19,"description":20,"timeFrame":21},"Comparison of antibody response after 3 doses of extended schedule between FSW and non-FSW","Antibody GMT at 18m and 19m between FSW and non-FSW.","19 month after the first doses",{"measure":23,"description":24,"timeFrame":25},"Celular response after each vaccine dose","Proportion of HPV16 and 18-specific B\u002FT cells at baseline, 2m, 7m, 18m and 19m.","19 months after the 1st dose",{"measure":27,"description":28,"timeFrame":29},"HPV persistent during 19 month or more among vaccines","4\\. Incidence (detection of the specific-type HPV DNA at least once during the follow-up period) and persistent HPV infection (defined as detection of the same HPV type in at least 2 samples not interrupted by negative sample during the follow-up period).","at least 19 months after the first dose",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":36,"maskingDescription":37,"whoMasked":38},"DOUBLE","Participants (FSW groups) will be randomly assigned to either of the vaccine schedules and will be given IDs. The link between participant IDs and vaccine groups are only known by Investigator.\n\nBarcodes will be used for samples and no personal identification nor participant ID is allowed in the samples.",[39,40],"PARTICIPANT","OUTCOMES_ASSESSOR","Primary objective:\n\nTo determine whether antibody geometric mean titer (GMT) to vaccine type HPV16 and HPV18 at 7 months (m) are non-inferior between female sex workers (FSW) aged 18-26 years who received the standard (0, 2m, 6m) and those received the extended 3-dose (at 0, 6m and 18m) 9vHPV schedule and age-matched non-FSW who received an extended 3-dose (at 0, 6m and 18m) 9vHPV schedule. This extended 3-dose schedule is in line with the recommended schedule by the vaccine manufacturer in Vietnam.\n\nSecondary objectives:\n\n1. To compare antibody GMT at 2m, 7m, 18m and 19m between FSW who are HPV DNA+\u002Fseropositive with FSW who are HPV DNA-\u002Fseronegative at baseline.\n2. To compare antibody GMT at 18m and 19m between FSW and non-FSW.\n3. To determine cellular immune responses to HPV16 and 18 at baseline, 2m, 7m, 18m and 19m.\n4. To measure incidence and 6m\u002F12m\u002F18m persistent HPV infection.\n\nPrimary hypothesis:\n\nHPV antibody GMT to HPV16 and 18 in FSW is non-inferior to those of young women of the same age group (non-FSW) at 7m.\n\nSecondary hypothesis:\n\n1. HPV antibody GMT are similar at 2m, 7m, 18m and 19m between FSW who are HPV DNA+\u002Fseropositive and HPV DNA-\u002Fseronegative at month 0.\n2. HPV antibody GMT are similar at 18m and 19m between FSW and non-FSW who received the extended schedule.\n3. Cellular immune responses to HPV16 and 18 are similar between FSW and non-FSW at 2m, 7m, 18m and 19m who received the extended schedule.\n4. No new vaccine-type HPV infection in FSW and non-FSW in all groups at 6m, 12m, 18m.",[43,49,54],{"label":44,"type":45,"description":46,"interventionNames":47},"Group 1 FSW","EXPERIMENTAL","100 FSWs aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months",[48],"Biological: Human papillomavirus 9-valent vaccine, Recombinant",{"label":50,"type":51,"description":52,"interventionNames":53},"Group 2 non-FSW","ACTIVE_COMPARATOR","100 non-FSW aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months",[48],{"label":55,"type":51,"description":56,"interventionNames":57},"Group 3 FSW","100 FSW aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-2-6 months",[48],[59],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"BIOLOGICAL","Human papillomavirus 9-valent vaccine, Recombinant","HPV vaccine manufactured by MSD consisted of 9HPV types: 6,11,16,18,31,33, 45, 52,58",[44,50,55],[65],"Gardasil 9",[67,70,73],{"name":68,"affiliation":5,"role":69},"Hong T Duong, MD, PhD","STUDY_DIRECTOR",{"name":71,"affiliation":5,"role":72},"Trang V Nguyen, PhD","PRINCIPAL_INVESTIGATOR",{"name":74,"affiliation":5,"role":72},"Tuan A Le, MD, PhD",[76,80],{"name":71,"role":77,"phone":78,"phoneExt":30,"email":79},"CONTACT","84902028181","nvt@nihe.org.vn",{"name":74,"role":77,"phone":81,"phoneExt":30,"email":82},"84983738688","lat@nihe.org.vn",[84,97,117],{"facility":85,"status":30,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":30},"Murdoch Children Research Institute","Parkville","Victoria","3052","Australia","AU",{"type":92,"coordinates":93},"Point",[94,95],144.95,-37.78333,{"lat":95,"lon":94},{"facility":98,"status":30,"city":99,"state":30,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Center for Supporting Community Development Initiatives SCDI-Vietnam","Haiphong","180000","Vietnam","VN",{"type":92,"coordinates":104},[105,106],106.68345,20.86481,{"lat":106,"lon":105},[109,113],{"name":110,"role":77,"phone":111,"phoneExt":30,"email":112},"Thanh TT Nham, MSc","84912069823","thamnham@scdi.org.vn",{"name":114,"role":77,"phone":115,"phoneExt":30,"email":116},"Nhung TH Tran, BSc","84326637935","nhungtran2@scdi.org.vn",{"facility":118,"status":30,"city":99,"state":30,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":119,"geoPoint":121,"contacts":122},"Hai Phong Center for Disease Control",{"type":92,"coordinates":120},[105,106],{"lat":106,"lon":105},[123,127,131],{"name":124,"role":77,"phone":125,"phoneExt":30,"email":126},"Kien T Dong, MD, MSc","84987046688","dtk.skmt@gmail.com",{"name":128,"role":77,"phone":129,"phoneExt":30,"email":130},"Hai H Phan, MD, MPH","84903265275","hai.cdc.haiphong@gmail.com",{"name":124,"role":132,"phone":30,"phoneExt":30,"email":30},"SUB_INVESTIGATOR",{"type":72,"investigatorFullName":134,"investigatorTitle":135,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Nguyen Van Trang","Acting Manager, Center for Biomedical Researches",[137,139,142],{"name":138,"class":6},"Murdoch Childrens Research Institute",{"name":140,"class":141},"CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES","UNKNOWN",{"name":118,"class":143},"OTHER_GOV","100568469",false,"NCT06681636","Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure","A Non-inferiority Study Comparing the Immunogenicity of a Standard or an Extended Three-dose Nonavalent Human Papillomavirus Vaccine Schedule Between High-risk Women Aged 18-26 Years and Age-matched Women in the General Population","HPV9vxFSW","Inclusion Criteria:\n\n* Is between the reporting ages of 18-26 years at the time of recruitment.\n* Engage in commercial sex in the last 6m (for FSW group) or have engaged in sexual activity (non-FSWs)\n* Willing and able to give written informed consent.\n* Willing to complete the follow-up requirements of the study.\n\nExclusion criteria\n\nParticipants meeting any of the following criteria will be excluded from the trial:\n\n* Pregnant or possibly pregnant\n* Has received any HPV vaccine previously\n* Has an axillary temperate greater than 38°C\n* Known allergies to any vaccine component\n* incapacity to provide consent\n* Currently receiving immunosuppressive medication or anti-cancer chemotherapy.\n* Known HIV infection.\n* Known Congenital immune deficiency syndrome.",true,"FEMALE","18 Years","26 Years",{"count":156,"type":157},300,"ESTIMATED","INTERVENTIONAL",[160],"PHASE2","A Study to evaluate if the 3 dose extended schedule (0-6-18 months) for the HPV vaccine Gardasil-9 provide similar immune responses and short term protection against HPV infection compared to the regular 3 dose schedule (0-2-6 months) in high risk women in Vietnam",[163,164,165,166],"HPV Infection","Cervical Cancer","Anogenital Cancer","Anogenital Warts",[168,169,101,170,171,172,173,174,175],"human papillomavirus","HPV vaccine","Female sex workers","immunogenicity","protection","extended schedule","HPV infection","cervical cancer","NOT_YET_RECRUITING","2024-11-07",{"date":179,"type":180},"2024-11-08","ACTUAL",{"date":182,"type":157},"2024-12-14",{"date":184,"type":157},"2027-12-31",{"name":5,"class":6},3]