Nctid:
NCT06221813
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000045464", "term"=>"Henipavirus Infections"}], "ancestors"=>[{"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000018184", "term"=>"Paramyxoviridae Infections"}, {"id"=>"D000018701", "term"=>"Mononegavirales Infections"}, {"id"=>"D000012327", "term"=>"RNA Virus Infections"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M16070", "name"=>"Stomatitis", "relevance"=>"LOW"}, {"id"=>"M27596", "name"=>"Vesicular Stomatitis", "relevance"=>"LOW"}, {"id"=>"M25498", "name"=>"Henipavirus Infections", "asFound"=>"Nipah Virus Infection", "relevance"=>"HIGH"}, {"id"=>"M20330", "name"=>"Paramyxoviridae Infections", "relevance"=>"LOW"}, {"id"=>"M20778", "name"=>"Mononegavirales Infections", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M17360", "name"=>"Vaccines", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>120}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04", "completionDateStruct"=>{"date"=>"2024-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-04-17", "studyFirstSubmitDate"=>"2024-01-15", "studyFirstSubmitQcDate"=>"2024-01-15", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-18", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-07", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Percentage of participants with local injection site and systemic adverse events (AEs)", "timeFrame"=>"14 days"}, {"measure"=>"Percentage of participants with joint related symptoms, rash and unsolicited AEs", "timeFrame"=>"28 days"}, {"measure"=>"Percentage of participants with neurologic AEs", "timeFrame"=>"Study Days 1-57"}, {"measure"=>"Percentage of participants with medically-attended AEs (MAAEs) and serious AEs (SAEs)", "timeFrame"=>"From time of injection through final study visit (Day 197)"}, {"measure"=>"Proportion of participants with recombinant vesicular stomatitis virus (rVSV) RNA (Cohort 1 only) in plasma, urine and saliva", "timeFrame"=>"From time of injection through Day 43"}, {"measure"=>"Proportion of participants who seroconvert compared to Day 1", "timeFrame"=>"Day 29 and Day 57"}, {"measure"=>"Geometric mean titers of IgG and ELISA neutralizing antibodies", "timeFrame"=>"Day 1, 29, 57"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["live, attenuated vaccine", "Nipah virus", "PHV02", "recombinant vesicular stomatitis virus"], "conditions"=>["Nipah Virus Infection"]}, "referencesModule"=>{"references"=>[{"pmid"=>"37731485", "type"=>"BACKGROUND", "citation"=>"Monath TP, Nichols R, Feldmann F, Griffin A, Haddock E, Callison J, Meade-White K, Okumura A, Lovaglio J, Hanley PW, Clancy CS, Shaia C, Rida W, Fusco J. Immunological correlates of protection afforded by PHV02 live, attenuated recombinant vesicular stomatitis virus vector vaccine against Nipah virus disease. Front Immunol. 2023 Sep 4;14:1216225. doi: 10.3389/fimmu.2023.1216225. eCollection 2023."}]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to test the safety and immunogenicity of PHV02 live, attenuated recombinant vesicular stomatitis virus vaccine expressing the Nipah Virus glycoprotein in healthy adult subjects. The main questions it aims to answer are:\n\n* which doses of PHV02 are safe to administer to and well-tolerated by healthy adult subjects as a 2 dose regimen given 1 month apart?\n* what is the immunologic response (Nipah-specific IgG ELISA antibody and neutralizing antibodies) to each dose level after a 2-dose regimen given 1 month apart? Participants will receive 2 intramuscular injections of PHV02 (2x105, 2x106, and 2x107 plaque-forming units \\[pfu\\]) or placebo on Day 1 and Day 29 and will be followed for 197 days."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"59 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Healthy, adult, male or non-pregnant, non-lactating females\n* Given written informed consent\n* No clinically significant health problems\n* Negative test for SARS-CoV-2\n* Agree to avoid conception through Day 57\n* Agree to minimize blood and body fluid exposures to others after vaccination through Day 57\n* Agree to avoid exposure to immunocompromised persons after vaccination through Day 57\n* Agree to avoid employment in industry involved with livestock after vaccination through Day 57\n\nExclusion Criteria:\n\n* Prior infection with Nipah virus, related Henipaviruses or Ebola virus\n* Prior infection with vesicular stomatitis virus (VSV)\n* Received VSV-vectored vaccine or Ebola vaccine\n* BMI \\< 18.5 or ≥ 35\n* Healthcare worker with direct physical contact with patients\n* Childcare worker in direct contact with children 5 years old or younger\n* Household contact who is immunodeficient, or on immunosuppressive medication\n* Hands-on food preparation job\n* Primary care or treatment of cattle, horses, or swine\n* Hepatitis B, hepatitis C, HIV-1, HIV-2, diabetes, atopic dermatitis (eczema), chronic inflammatory disease, autoimmune or autoinflammatory disorder, malignancy, chronic or active neurologic disorder\n* History of severe reactions to any vaccine or history of severe allergies\n* Receipt of investigational product up to 30 days prior to, or planned receipt within 196 days after randomization, or ongoing participation in another interventional clinical trial.\n* Receipt of licensed non-live vaccines within 14 days of planned study immunization (30 days for live vaccines) or planned receipt of non-live or live vaccine within 60 days after first study immunization (30 days after the 2nd vaccination).\n* Known allergy to components of PHV02\n* Injection sites obscured by tattoos or physical condition\n* Significant psychiatric or medical condition or laboratory abnormality on screening\n* History of Guillain Barre Syndrome or any chronic or acute neurological disorder\n* Alcohol or illicit drug abuse within past 5 years\n* Pregnant or lactating female\n* Administration of blood or IgG within 120 days preceding study\n* History of blood donation within 60 days of study\n* Unwilling to undergo diagnostic evaluation of rash (skin biopsy, if indicated) or joint symptoms (arthrocentesis if indicated by joint effusion), in both cases if acceptable to subject\n* Elective surgery planned during the study period"}, "identificationModule"=>{"nctId"=>"NCT06221813", "briefTitle"=>"Study to Evaluate Safety and Immunogenicity of a Prime-Boost Regimen of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Public Health Vaccines LLC"}, "officialTitle"=>"A Phase 1b Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Prime-Boost Regimen of Three Dose Levels of PHV02, a Nipah Virus Vaccine Candidate (rVSV-ΔG-EBOV GP-NiVG) in Healthy Adults", "orgStudyIdInfo"=>{"id"=>"PHV02-C-102"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Cohort 1 (first 60 subjects) PHV02 high dose", "interventionNames"=>["Biological: PHV02"]}, {"type"=>"EXPERIMENTAL", "label"=>"Cohort 1 (first 60 subjects) PHV02 medium dose", "interventionNames"=>["Biological: PHV02"]}, {"type"=>"EXPERIMENTAL", "label"=>"Cohort 1 (first 60 subjects) PHV02 low dose", "interventionNames"=>["Biological: PHV02"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Cohort 1 (first 60 subjects) Placebo", "interventionNames"=>["Biological: Lactated Ringer's"]}, {"type"=>"EXPERIMENTAL", "label"=>"Cohort 2 (next 60 subjects) PHV02 high dose", "interventionNames"=>["Biological: PHV02"]}, {"type"=>"EXPERIMENTAL", "label"=>"Cohort 2 (next 60 subjects) PHV02 medium dose", "interventionNames"=>["Biological: PHV02"]}, {"type"=>"EXPERIMENTAL", "label"=>"Cohort 2 (next 60 subjects) PHV02 low dose", "interventionNames"=>["Biological: PHV02"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Cohort 2 (next 60 subjects) Placebo", "interventionNames"=>["Biological: Lactated Ringer's"]}], "interventions"=>[{"name"=>"PHV02", "type"=>"BIOLOGICAL", "description"=>"Nipah virus vaccine", "armGroupLabels"=>["Cohort 1 (first 60 subjects) PHV02 high dose", "Cohort 1 (first 60 subjects) PHV02 low dose", "Cohort 1 (first 60 subjects) PHV02 medium dose", "Cohort 2 (next 60 subjects) PHV02 high dose", "Cohort 2 (next 60 subjects) PHV02 low dose", "Cohort 2 (next 60 subjects) PHV02 medium dose"]}, {"name"=>"Lactated Ringer's", "type"=>"BIOLOGICAL", "description"=>"Placebo", "armGroupLabels"=>["Cohort 1 (first 60 subjects) Placebo", "Cohort 2 (next 60 subjects) Placebo"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"92801", "city"=>"Anaheim", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Howard Pho", "role"=>"CONTACT", "email"=>"h.pho@cenexel.com", "phone"=>"714-774-7777"}], "facility"=>"Cenexel ACT (Anaheim Clinical Trials)", "geoPoint"=>{"lat"=>33.83529, "lon"=>-117.9145}}, {"zip"=>"33024", "city"=>"Hollywood", "state"=>"Florida", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Mary Fernandez", "role"=>"CONTACT", "email"=>"m.fernandez@cenexel.com", "phone"=>"954-919-7723"}], "facility"=>"Cenexel RCA (Research Centers of America)", "geoPoint"=>{"lat"=>26.0112, "lon"=>-80.14949}}, {"zip"=>"84107", "city"=>"Salt Lake City", "state"=>"Utah", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Scott Zunkowski", "role"=>"CONTACT", "email"=>"s.zunkowski@cenexel.com", "phone"=>"801-261-2000"}], "facility"=>"Cenexel JBR (JBR Clinical Research)", "geoPoint"=>{"lat"=>40.76078, "lon"=>-111.89105}}], "centralContacts"=>[{"name"=>"Terry Piedra", "role"=>"CONTACT", "email"=>"t.piedra@cenexel.com", "phone"=>"305-596-3125"}, {"name"=>"Amanda Gonzalez", "role"=>"CONTACT", "email"=>"amanda.gonzalez@cenexel.com", "phone"=>"813.817.7984"}], "overallOfficials"=>[{"name"=>"Joan Fusco, PhD", "role"=>"STUDY_CHAIR", "affiliation"=>"Public Health Vaccines"}, {"name"=>"Thomas P Monath, MD", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Quigley Biopharma"}, {"name"=>"Gray P Heppner, MD", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Quigley Biopharma"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Public Health Vaccines LLC", "class"=>"INDUSTRY"}, "collaborators"=>[{"name"=>"Coalition for Epidemic Preparedness Innovations", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
