[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616295":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":27,"locations":36,"responsibleParty":53,"collaborators":18,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":90,"whyStopped":18,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Institut d'Investigació Biomèdica de Bellvitge","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervantional Arm","EXPERIMENTAL","Women randomisied on this arm will receive their first dose at Month 0 (M0).",[13],"Biological: Nonavalent HPV vaccine (9vHPV)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm","NO_INTERVENTION","Women randomised on this arm will not to be vaccinated at Month 0 (M0).",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Nonavalent HPV vaccine (9vHPV)","Nonavalent HPV vaccine (9vHPV\u002F Gardasil-9™). Sterile suspension, 0.5 ml dose, intramuscular, prepared from the highly purified viruslike particles (VLPs) of the major capsid L1 protein from 9 HPV types: 6\u002F11\u002F16\u002F18\u002F31\u002F33\u002F45\u002F52\u002F58. 9vHPV is currently indicated in the EU in individuals from 9 years of age for the prevention of diseases caused by vaccine's 9 HPV types: genital warts (HPV6 and 11) and premalignant lesions and cancers affecting the cervix, vulva, vagina and anus (HPV16, 18, 31, 22, 45, 52 and 58). It was authorized for marketing in the EU on June 9th, 201",[9],[26],"Gardasil-9™",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":18,"email":32},"Miquel Àngel Pavón Ribas PhD","CONTACT","+34932607123","mpavon@iconcologia.net",{"name":34,"role":30,"phone":18,"phoneExt":18,"email":35},"Elena Ruiz Puig","eruiz@idibell.cat",[37],{"facility":38,"status":18,"city":39,"state":18,"zip":18,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Kambia Research Centre","Freetown","Sierra Leone","SL",{"type":43,"coordinates":44},"Point",[45,46],-13.2356,8.48714,{"lat":46,"lon":45},[49],{"name":50,"role":30,"phone":51,"phoneExt":18,"email":52},"Daniel Tindanbil","+232-33634212","Daniel.Tindanbil@lshtm.ac.uk",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Miquel Angel Pavon Ribas","Chief of Infection and Cancer Laboratory. Principal Investigator-PHD","100616295","phase-2-study-assessing-reduced-hpv-infectivity-and-transmission-in-hpv-positive-women-following-vaccination-with-9vhpv-100616295",false,"NCT07303751","Study Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccination With 9vHPV","HPV Vaccination and Infectivity Reduction in HPV-positive Women","RIFT-SSA","Inclusion Criteria:\n\n* Born female\n* Aged between 18-29 years old;\n* Living in Kambia district (or neighbouring district if included) without plans to move away in the next 12 months;\n* Willing to participate in the study and have signed the informed consent form;\n* In good health as determined by a medical history (a physical examination will be conducted if necessary according to the clinician's judgement);\n* Willing to be tested for HIV;\n* Are HIV negative at the screening visit;\n* Not pregnant;\n* Able to pass a Test of Understanding (TOU);\n* Willing to provide cervical, urine and blood samples;\n* Agree to be vaccinated with a single dose of Gardasil9® if randomised to the vaccine arm at Day 0;\n* Have no visible suspicious cervical lesions on examination.\n* Agree to a pregnancy test at screening and before any HPV vaccination.\n\nExclusion Criteria:\n\n* They have been previously vaccinated against HPV;\n* They have a chronic condition, such as autoimmune conditions, degenerative diseases, neurologic or genetic diseases among others;\n* They are HIV positive or immunocompromised;\n* They are pregnant or planning to get pregnant in the next 12 months;\n* They are less than three months post-partum or currently breastfeeding;\n* They are allergic to one of the vaccine components or to latex;\n* They are sexually active and are not using, or are not willing to use, an effective birth control method from D-14 until 60 days after the last vaccine dose\n* The nurse or clinician determining the eligibility, in agreement with principal investigator, considers that there is a reason that precludes participation.","FEMALE","18 Years","29 Years",{"count":69,"type":70},80,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","This is a randomized, open-label trial, to assess whether a single dose of HPV nonavalent vaccine, administered to HIV uninfected, unvaccinated women with high risk HPV16\u002F18\u002F31\u002F33\u002F45\u002F52 or 58 can decrease the infectivity of shed HPV viruses.\n\nOur hypothesis is that vaccination will have little or no impact on HPV sample positivity by DNA PCR since the viral particles will continue to be produced and released, but that particles will be neutralized by vaccine-induced antibodies, thereby reducing their infective capacity. Cervical samples will be collected at randomisation and at 6 months, to compare infectivity of shed HPV viruses.",[76,77,78],"HPV","High-risk HPV (Any Strain)","Human Papillomavirus (HPV) Infections",[80,81,82,78,83,84,85,86,87,88,89],"Cervical cancer","Cervical Intraepithelial Neoplasia Grade I\u002F II\u002F III (CIN I\u002FII\u002FIII)","Squamous Intraepithelial Lesions of the Cervix, High\u002F Low Grade","High-risk HPV","HPV-16\u002F 18","HPV DNA Tests","HPV Vaccines","HPV Nonavalent Vaccine","Gardasil-9","9vHPV","NOT_YET_RECRUITING","2026-02-09",{"date":93,"type":94},"2026-02-11","ACTUAL",{"date":96,"type":70},"2026-02-01",{"date":98,"type":70},"2027-02-01",{"name":5,"class":6},1]