[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"human-papillomavirus-hpv-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:human-papillomavirus-hpv-infections":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,61],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100464977","phase-4-a-study-to-assess-the-reduction-of-human-papillomavirus-hpv-viral-infectivity-and-transmission-in-hpv-positive-women-after-vaccination-with-9vhpv-rift-hpv-100464977",false,"NCT05334706","A Study to Assess the Reduction of Human Papillomavirus (HPV) Viral Infectivity and Transmission in HPV-Positive Women After Vaccination With 9vHPV (RIFT-HPV)","A Non-Randomized, Open-Label Study to Assess the Reduction of Human Papillomavirus (HPV) Viral Infectivity and Transmission in HPV16\u002F18-Positive Women After Vaccination With 9vHPV, a Multivalent L1 Virus-like Particle Vaccine, Evaluated in Cervical, Anal and Oral Samples Obtained After One, Two, and Three Vaccine Doses (RIFT-HPV1\u002FRIFT-HPV2)","RIFT-HPV","Inclusion Criteria:\n\n* Women.\n* Aged 18 years or older for RIFT-HPV Cohort 1 and 2, attending a routine cervical cancer screening visit or gynaecological visit.\n* Positive for HPV16, 18 or double-positive for 16 and 18 and negative for the rest of high-risk HPV types in a cervical sample.\n* Recently diagnosed for their HPV-positivity (within the last 10 months).\n* Meet one of the following criteria:\n\nhave no apparent cervical lesion (Cohort 1). have a CIN1\u002F2 lesion which is eligible for conservative treatment (cohort 1). have HPV 16 and\u002For HPV 18 positive anal test with non-apparent anal lesions or with anal lesions eligible for conservative treatment (Cohort 2).\n\nhave HPV 16 and\u002For HPV 18 positive cervical test with vulvar premalignant lesion or condylomas, associated to HPV infection (Cohort 2).\n\nExclusion Criteria:\n\n* Presence of any cervical lesion that requires clinical intervention within 7 months that could significantly affect cervical epithelia (and therefore, HPV viral production), such as cervical conization.\n* History of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention.\n* History of allergy to any vaccine component, including aluminum, yeast, or BENZONASETM (nuclease, Nicomedia).\n* History of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection of study vaccine.\n* History of splenectomy.\n* History of ano-genital cancer or HPV-related head and neck cancer.\n* Pregnancy at the time of signing informed consent or planning to become pregnant within the full duration of the study.","FEMALE","18 Years",{"count":20,"type":21},69,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This is a non-randomized, open label study to assess the reduction of Human Papillomavirus (HPV) infectivity and transmission in women positive for HPV16 and\u002For 18 in a cervical, oral and anal sample and vaccinated with 9vHPV\u002FGardasil-9™.\n\nThe primary objective of the study is to demonstrate that vaccination with a 3-dose regimen of 9vHPV will reduce viral infectivity in HPV 16\u002F18\u002F16+18-positive women. This objective rests upon the hypothesis that, since vaccination with 9vHPV triggers the production of type-specific HPV antibodies which are exudated to the cervical and other infected mucosae, these antibodies adhere to and neutralize newly produced HPV 16\u002F18 viral particles also present in the mucosae, thus reducing HPV's infective capacity and transmission to sexual partners.\n\nSecondary objectives of the study are:\n\n* To determine HPV antibody levels before and after vaccination for each of the 9vHPV-covered HPV types (6, 11, 16, 18, 31, 33, 45, 52, and 58), to distinguish an induced antibody production due to 9vHPV vaccination from a natural response to an HPV infection (when antibody production is expected to be lower).\n* To demonstrate viral infectivity reduction in HPV 16\u002F18\u002F16+18 after vaccination with 1-dose or 2-dose regimen of 9vHPV. Since antibody production after administration of 2 vaccine doses is not inferior to 3 doses, infectivity reduction is expected to be detected after 2 doses, and at least partially after one dose.\n\nThe main endpoint of the study is the evaluation of the HPV infective capacity in cervical, anal and oral samples from HPV 16, 18 or 16+18-positive women, using a cellular assay that models in-vitro the cervical mucosa. In brief, the specific HPV biomarker E1\\^E4 is measured in HaCaT keratinocytes after being cultured with study samples and thus, exposed to HPV16\u002F18 viral particles. A reduction in E1\\^E4 expression is expected for keratinocytes exposed to samples taken after vaccination with 9vHPV, since the specific HPV antibodies also present in these samples would bind HPV viral particles and prevent infection of cultured keratinocytes.\n\nOther endpoints included in the study are:\n\n* Detection of antibodies against HPV types covered by 9vHPV (6\u002F11\u002F16\u002F18\u002F31\u002F33\u002F45\u002F52\u002F58) by specific immunoassays (ELISA, cLIA).\n* HPV16\u002F18 virion detection using ELISA and electronic microscopy.\n* HPV DNA detection and genotyping, using Anyplex HPV28. These endpoints are performed in cervical, anal and oral samples from HPV 16, 18 or 16+18-positive women\n* Titration of antibodies against HPV types covered by 9vHPV in serum samples from HPV 16, 18 or 16+18-positive women using ELISA or cLIA.\n\nA minimum of 39 and 30 women will be enrolled in two different study population cohorts, respectively:\n\n* RIFT-HPV 1 cohort: non-vaccinated adult women aged 35 years or older, positive for HPV16-, 18-, or double positive for 16 and 18, without lesion or with cervical intraepithelial neoplasia (CIN) 1\u002F2 lesion eligible for conservative treatment.\n* RIFT-HPV 2 cohort: non-vaccinated adult women aged 27 years or older, positive for HPV16-, 18-, or double positive for 16 and 18, with multiple cervical, vulvar and\u002For anal lesions, with cervical lesions eligible for conservative treatment.\n\nCandidates to participate in the study are selected according to the HPV DNA test result in a cervical sample taken in their routine cervical cancer screening visit or in their routine gynaecological follow-up visit.\n\nThere is no control group in this study: all participants are expected to complete all the per-protocol procedures in a total of 4 study visits within an average of 7 months' duration: Visit 1\u002F Day1, Visit 2\u002FMonth 2, Visit 3\u002FMonth 6, and Visit 4\u002FMonth 7.\n\nThe study procedures are the following:\n\n* Pregnancy test on a urine sample in Visit 1 (pregnant women are excluded from the study).\n* Completion of a questionnaire about the participant's health status, use of oral contraception and sexual activity in Visits 1 and 4.\n* Cervical, anal oral and blood sample collection Visits 1, 2 and 3 before receiving 9vHPV vaccination, and in Visit 4.\n* Intramuscular administration of 9vHPV in a three-dose regimen in Visits 1, 2 and 3.\n\nRegarding data analysis for primary objective assessment, differences in the infectivity rate before (Day 1\u002F Visit 1) and after vaccination with 3 doses of 9vHPV (Month 7\u002F Visit 4) will be compared in cervical, anal and oral samples using non-parametric Wilcoxon signed rank test. The same assessment will be done in 1- or 2-dose vaccination scenario.\n\nAntibody production before and after vaccination will be summarized for each of the 9vHPV-covered HPV types.",[27,28,29,30],"Cervical Intraepithelial Neoplasia Grade I\u002F II\u002F III (CIN I\u002FII\u002FIII)","Human Papillomavirus (HPV) Infections","High-risk HPV","HPV-16\u002F 18",[32,27,33,34,28,29,30,35,36,37,38,39,40,41,42,43,44,45,46,47],"Cervical cancer","Squamous Intraepithelial Lesions of the Cervix, High\u002F Low Grade.","Uterine Cervical Neoplasms","HPV DNA Tests","Anyplex HPV28","HPV Vaccines","HPV Nonavalent Vaccine","Gardasil-9","9vHPV","cLIA","HaCaT Cells","Keratinocytes","Cell Culture","ELISA","Immunoassay","Electron Microscopy","RECRUITING","2026-02-19",{"date":51,"type":52},"2026-02-23","ACTUAL",{"date":54,"type":52},"2022-09-13",{"date":56,"type":21},"2026-12",{"name":58,"class":59},"Miquel Angel Pavon Ribas","OTHER",1,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":60},"100616295","phase-2-study-assessing-reduced-hpv-infectivity-and-transmission-in-hpv-positive-women-following-vaccination-with-9vhpv-100616295","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.","29 Years",{"count":71,"type":21},80,[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.",[76,77,28],"HPV","High-risk HPV (Any Strain)",[32,27,79,28,29,30,35,37,38,39,40],"Squamous Intraepithelial Lesions of the Cervix, High\u002F Low Grade","NOT_YET_RECRUITING","2026-02-09",{"date":83,"type":52},"2026-02-11",{"date":85,"type":21},"2026-02-01",{"date":87,"type":21},"2027-02-01",{"name":89,"class":59},"Institut d'Investigació Biomèdica de Bellvitge"]