[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603881":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":31,"locations":49,"responsibleParty":63,"collaborators":65,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":31,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":99,"whyStopped":31,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Nuravax, Inc.","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Active - DUVAX 200 µg","EXPERIMENTAL","Participants receive three intramuscular injections of DUVAX 200 µg formulated with Adjuvant at Weeks 0, 4, and 22.",[13],"Biological: DUVAX 200 µg",{"label":15,"type":10,"description":16,"interventionNames":17},"Active - DUVAX 400 µg","Participants receive three intramuscular injections of DUVAX 400 µg formulated with Adjuvant at Weeks 0, 4, and 22.",[18],"Biological: DUVAX 400 µg",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo (Adjuvant only)","PLACEBO_COMPARATOR","Participants receive three intramuscular injections of placebo (adjuvant formulation without active antigen) at Weeks 0, 4, and 22.",[24],"Biological: Placebo (Adjuvant only)",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BIOLOGICAL","DUVAX 200 µg","Intramuscular injection of 200 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"DUVAX 400 µg","Intramuscular injection of 400 µg DUVAX formulated with Adjuvant, administered at Weeks 0, 4, and 22",[15],{"type":27,"name":20,"description":37,"armGroupLabels":38,"otherNames":31},"Intramuscular injection of placebo consisting of Adjuvant formulation in phosphate-buffered saline without active antigen, administered at Weeks 0, 4, and 22",[20],[40,44,46],{"name":41,"affiliation":42,"role":43},"Anahit Ghochikyan, PhD","IMM","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":5,"role":43},"David Cribbs, PhD",{"name":47,"affiliation":5,"role":48},"Roman Kniazev","STUDY_CHAIR",[50],{"facility":51,"status":31,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":31},"Palm Springs Community Health Center","Miami Lakes","Florida","33014","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-80.30866,25.90871,{"lat":61,"lon":60},{"type":64,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[66,69],{"name":67,"class":68},"National Institute on Aging (NIA)","NIH",{"name":70,"class":71},"Institute for Molecular Medicine","OTHER","100603881","phase-1-duvax-a-phase-1-alzheimers-vaccine-study-targeting-amyloid-beta-and-tau-100603881",false,"NCT07142278","DUVAX: A Phase 1 Alzheimer's Vaccine Study Targeting Amyloid-Beta and Tau","A Phase 1 Study of the Safety and Tolerability of DUVAX, a Dual-Target Alzheimer's Vaccine (Amyloid-Beta and Tau), in Healthy Volunteers","DU-PRISM","Inclusion Criteria:\n\n* Healthy males and non-pregnant, non-lactating females, 40-65 years old\n* BMI between 18.0 and 32.0 kg\u002Fm²\n* Medically healthy with no significant abnormalities in medical history, exam, labs, ECG, or MRI\n* Signed informed consent\n* Women of childbearing potential: negative pregnancy test and use of effective contraception\n* Men: vasectomized or agree to use condoms \u002F not donate sperm during the study period\n\nExclusion Criteria:\n\n* Clinically significant medical or psychiatric illness that may affect safety or study results\n* MRI abnormalities (e.g., infarcts, microbleeds, ARIA-E) or contraindications to MRI\n* Significant lab abnormalities (e.g., liver, kidney, hematology) or positive HIV\u002FHBV\u002FHCV tests\n* Uncontrolled blood pressure, abnormal heart rate, or prolonged QTc interval\n* Recent serious illness, surgery, or investigational drug use within 30 days\n* Prior amyloid-beta or tau immunotherapy within 1 year\n* Use of immunosuppressive agents or chronic anticoagulants\n* History of severe vaccine reactions, autoimmune disease, or significant allergies",true,"ALL","40 Years","65 Years",{"count":85,"type":86},24,"ESTIMATED","INTERVENTIONAL",[89],"PHASE1","This Phase 1 study will test the safety and immune response of the investigational vaccine DUVAX in healthy adults. Participants will be randomly assigned to receive either DUVAX or placebo by intramuscular injection. The study will evaluate how well the vaccine is tolerated and whether it produces antibodies against Alzheimer's disease-related proteins.",[92,93,94],"Alzheimer Disease","Alzheimer Disease (AD)","Preclinical Alzheimer's Disease",[96,97,98],"Asymptomatic Alzheimer Disease","Preclinical Alzheimer's disease","Alzheimer's disease","NOT_YET_RECRUITING","2025-10-20",{"date":102,"type":103},"2025-10-22","ACTUAL",{"date":105,"type":86},"2025-11-01",{"date":107,"type":86},"2027-07-31",{"name":5,"class":6},1]