[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054174":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":15,"centralContacts":7,"locations":19,"responsibleParty":63,"collaborators":7,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":7,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":7,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":92,"whyStopped":7,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",null,[9,12],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"BIOLOGICAL","APL 400-047",{"type":13,"name":14,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","Bupivacaine hydrochloride",[16],{"name":17,"affiliation":7,"role":18},"Mulligan M","STUDY_CHAIR",[20,33,43,53],{"facility":21,"status":7,"city":22,"state":23,"zip":24,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":7},"Univ of Alabama at Birmingham","Birmingham","Alabama","35294","United States","US",{"type":28,"coordinates":29},"Point",[30,31],-86.80249,33.52066,{"lat":31,"lon":30},{"facility":34,"status":7,"city":35,"state":36,"zip":37,"country":25,"countryCode":26,"cosmosGeoPoint":38,"geoPoint":42,"contacts":7},"Univ of Rochester Med Ctr","Rochester","New York","14642",{"type":28,"coordinates":39},[40,41],-77.61556,43.15478,{"lat":41,"lon":40},{"facility":44,"status":7,"city":45,"state":46,"zip":47,"country":25,"countryCode":26,"cosmosGeoPoint":48,"geoPoint":52,"contacts":7},"Vanderbilt Univ Hosp","Nashville","Tennessee","37232",{"type":28,"coordinates":49},[50,51],-86.78444,36.16589,{"lat":51,"lon":50},{"facility":54,"status":7,"city":55,"state":56,"zip":57,"country":25,"countryCode":26,"cosmosGeoPoint":58,"geoPoint":62,"contacts":7},"Univ of Washington \u002F Pacific Med Ctr","Seattle","Washington","98144",{"type":28,"coordinates":59},[60,61],-122.33207,47.60621,{"lat":61,"lon":60},{"type":7,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":64,"oldOrganization":65},"Rona Siskind","DAIDS","100054174","phase-1-a-phase-i-safety-and-immunogenicity-trial-of-the-facilitated-hiv-1-gag-pol-dna-vaccine-apl-400-047-apollon-inc-given-intramuscularly-by-needle-and-syringe-or-biojector-2000-needle-free-jet-injection-system-in-hiv-1-uninfected-adult-volunteers-100054174",false,"NCT00001088","A Phase I Safety and Immunogenicity Trial of the Facilitated HIV-1 Gag-Pol DNA Vaccine (APL-400-047, Apollon, Inc.) Given Intramuscularly by Needle and Syringe or Biojector 2000 Needle-Free Jet Injection System in HIV-1 Uninfected Adult Volunteers","Inclusion Criteria\n\nPatients must have:\n\n* Negative ELISA for HIV within 8 weeks of immunization.\n* CD4 count \\>= 400 cells\u002Fmm3.\n* Normal history and physical examination.\n* Negative for Hepatitis B surface antigen.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions and symptoms are excluded:\n\n* Positive for anti-dsDNA antibodies.\n* Medical or psychiatric condition or occupational responsibilities that preclude compliance with the protocol.\n* Present psychosis.\n* Active syphilis (eligible if serology documented to be a false positive or due to remote, i.e., \\> 6 months treated, infection).\n* Active tuberculosis (eligible if positive purified protein derivative test and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy).\n\nConcurrent Medication:\n\nExcluded:\n\n* Immunosuppressive medications.\n\nPatients with the following prior conditions are excluded:\n\n* History of immunodeficiency, chronic illness, or autoimmune disease.\n* History of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure.\n* History of suicide attempts, recent suicidal ideation or past psychosis.\n* History of anaphylaxis or other serious adverse reactions to vaccines.\n* History of severe allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).\n* Hypersensitivity to bupivacaine or other amide-type anesthetics.\n\nPrior Medication:\n\nExcluded:\n\n* Prior receipt of HIV-1 vaccines or placebo recipient in a previous HIV vaccine trial.\n* Use of experimental agents within 30 days prior to study.\n* Live attenuated vaccines within 60 days of study.\n* Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) within 2 weeks prior to study.\n\nPrior Treatment:\n\nExcluded:\n\nReceipt of blood products or immunoglobulin in the past 6 months.\n\nRisk Behavior:\n\nExcluded:\n\nVolunteers having identifiable higher risk behavior for HIV infection as determined by screening questions designed to identify risk factors for HIV infection, specifically:\n\n* History of injection drug use within the last 12 months prior to enrollment.\n* Higher or intermediate risk sexual behavior as defined by the AVEG (i.e., meeting the criteria for AVEG Risk Group C or D).",true,"ALL","18 Years","60 Years",{"count":77,"type":7},40,"INTERVENTIONAL",[80],"PHASE1","To evaluate the safety, tolerability and immunogenicity in humans of the APL-400-047 vaccine when administered intramuscularly by needle and syringe at 1 of 3 doses or by Biojector at the intermediate dose. \\[AS PER AMENDMENT 07\u002F98: To evaluate the tolerability, safety, and immunogenicity of an increased dose in an additional group of volunteers.\\] DNA-based immunization mimics live-attenuated virus vaccination by stimulation of both the humoral and cellular arms of the immune system; thus, potentially providing the advantages of a live virus vaccination but without the potential risks. It is essential that novel vaccine strategies (including DNA-based immunizations) continue to be developed and enter Phase I human testing because to date, no candidate vaccine from any of the approximately 30 AVEG Phase I or II trials has progressed to a Phase III efficacy trial. Use of a Biojector jet gun for vaccine delivery may also have potential psychological, comfort, safety and immunologic advantages over the traditional needle and syringe method of delivery.",[83],"HIV Infections",[85,86,87,88,89,90,91],"Injections, Intramuscular","AIDS Vaccines","HIV Seronegativity","Dose-Response Relationship, Immunologic","Fusion Proteins, gag-pol","Vaccines, DNA","HIV Preventive Vaccine","COMPLETED","2008-09-26",{"date":95,"type":96},"2008-09-29","ESTIMATED",{"date":98,"type":7},"1997-07",{"date":100,"type":101},"2001-02","ACTUAL",{"name":5,"class":6},4]