[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503005":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":53,"collaborators":24,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":24,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":24,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":24,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"BlueSky Immunotherapies GmbH","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"FluBHPVE6E7","EXPERIMENTAL","intracervical and intramuscular 0.5 ml per dose 3 doses (12 weeks)",[13],"Biological: FluBHPVE6E7",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","Intracervical administration for first dose followed by intramuscular administration for subsequent doses at recommended dose level and determined schedule",[9],null,{"type":26,"name":15,"description":27,"armGroupLabels":28,"otherNames":24},"DRUG","Intracervical administration for first dose followed by intramuscular administration for subsequent doses at determined schedule",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"BlueSky Clinical Operations","CONTACT","+43 664 1888028","clinical@bluesky-itx.com",[36],{"facility":37,"status":38,"city":39,"state":24,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Univerzitná nemocnica Bratislava","RECRUITING","Bratislava","82606","Slovakia","SK",{"type":44,"coordinates":45},"Point",[46,47],17.10674,48.14816,{"lat":47,"lon":46},[50],{"name":24,"role":32,"phone":51,"phoneExt":52,"email":24},"00421 2 48234","111",{"type":54,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100503005","phase-1-phase-1-dose-escalation-study-of-flubhpve6e7-in-hpv16-infected-women-100503005",false,"NCT05829629","Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women","Randomised, Double-blind, Placebo-controlled Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women with NILM, ASC-US, LSIL or Low-grade CIN","Inclusion Criteria:\n\n* Females, 18-49 years of age with HPV16 infection and cervical cytological evaluation negative for intraepithelial lesion or malignancy (NILM), atypical squamous cells of undetermined significance (ASC-US), low grade squamous intraepithelial lesion (LSIL), or low-grade cervical intraepithelial neoplasia (CIN1)\n* HPV16 infection has been confirmed at least twice by a validated HPV test separated by at least 3 months\n* Satisfactory colposcopy\n* No clinically significant out of range haematological, renal or hepatic laboratory tests\n* Normal screening ECG or screening ECG with no clinically significant findings, as judged by the investigator\n* Negative serum pregnancy test at screening\n* Agree to use a reliable form of contraception during the whole study period.\n* Provides written informed consent\n\nExclusion Criteria:\n\n* Any vaccination within 6 weeks of day 0\n* Active significant viral infections including influenza, CMV, and EBV within 30 days of receiving study treatment\n* Co-infection with hepatitis B, hepatitis C, or HIV or having other immune deficient states\n* Current Bacterial Vaginosis (BV) infection\n* Current high-grade cervical intraepithelial neoplasia (CIN2\u002F3)\n* Prior history of or current malignancy, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VAIN), atypical glandular cells (AGC), adenocarcinoma in situ (AIS) or any suspicion of either micro-invasive or invasive disease\n* Pregnancy, breastfeeding\n* Influenza-like illness (ILI) within 3 months of day 0\n* Known hypersensitivity to oseltamivir or any of its components\n* Any anatomical condition of the cervix, including that resulting from previous cervical surgery, congenital malformation or other condition, that would interfere with a complete evaluation of the cervix\n* Current pelvic inflammatory disease, cervicitis, or other gynaecological infection as per colposcopy and clinical examination\n* Serious, concomitant disorder, including active systemic infection requiring treatment\n* Presence of acute or chronic bleeding or clotting disorder, or use of blood thinners within 2 weeks of day 0\n* A proven or suspected autoimmune disease\n* Immunosuppression including any concurrent condition requiring the continued use of systemic or topical steroids, or the use of immunosuppressive agents, disease modifying doses of anti-rheumatic drugs, and biologic disease modifying drugs. Any immunosuppressive agents containing corticosteroids or monoclonal antibodies specific for the treatment of obstructive airway, ear or vestibular diseases are permissible.\n* Acute or history of Herpes genitalis\n* Prior major surgery within 4 weeks of day 0\n* Administration of any blood product within 3 months of enrolment\n* Any current significant cardiac, hepatic or renal disease or history of clinically significant, medically unstable disease\n* Any current or history of neurological disease including history of seizures\n* Participation in another experimental protocol\u002Fuse of investigational drug during the prior two months","FEMALE","18 Years","49 Years",{"count":66,"type":67},20,"ESTIMATED","INTERVENTIONAL",[70],"PHASE1","BS-02 is a randomised, double-blind, placebo-controlled, phase 1 dose escalation study to assess the safety, tolerability and immunogenicity of FluBHPVE6E7, in women infected with HPV-16. with cervical cytological evaluation negative for intraepithelial lesion or malignancy (NILM), atypical squamous cells of undetermined significance (ASC-US), low grade squamous intraepithelial lesion (LSIL), or low-grade cervical intraepithelial neoplasia (CIN1).",[73,74],"HPV Infection","HPV-Related Cervical Carcinoma","2025-02-12",{"date":77,"type":78},"2025-02-14","ACTUAL",{"date":80,"type":78},"2023-09-12",{"date":82,"type":67},"2025-11",{"name":5,"class":6},1]