Nctid:
NCT00001072
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D015658", "term"=>"HIV Infections"}], "ancestors"=>[{"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D016180", "term"=>"Lentivirus Infections"}, {"id"=>"D012192", "term"=>"Retroviridae Infections"}, {"id"=>"D012327", "term"=>"RNA Virus Infections"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M2593", "name"=>"Blood-Borne Infections", "relevance"=>"LOW"}, {"id"=>"M15558", "name"=>"Sexually Transmitted Diseases", "relevance"=>"LOW"}, {"id"=>"M17933", "name"=>"Sexually Transmitted Diseases, Viral", "relevance"=>"LOW"}, {"id"=>"M18640", "name"=>"Lentivirus Infections", "relevance"=>"LOW"}, {"id"=>"M15026", "name"=>"Retroviridae Infections", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"C010770", "term"=>"polysaccharide-K"}], "ancestors"=>[{"id"=>"D000276", "term"=>"Adjuvants, Immunologic"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000903", "term"=>"Antibiotics, Antineoplastic"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D007369", "term"=>"Interferon Inducers"}, {"id"=>"D011837", "term"=>"Radiation-Protective Agents"}, {"id"=>"D020011", "term"=>"Protective Agents"}], "browseLeaves"=>[{"id"=>"M17360", "name"=>"Vaccines", "relevance"=>"LOW"}, {"id"=>"M340819", "name"=>"polysaccharide-K", "asFound"=>"Xeomin", "relevance"=>"HIGH"}, {"id"=>"M3628", "name"=>"Adjuvants, Immunologic", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M10407", "name"=>"Interferons", "relevance"=>"LOW"}, {"id"=>"M21869", "name"=>"Protective Agents", "relevance"=>"LOW"}, {"id"=>"M14684", "name"=>"Radiation-Protective Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"PREVENTION"}, "enrollmentInfo"=>{"count"=>140}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1999-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-28", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-11-04", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Vaccines, Synthetic", "HIV Envelope Protein gp120", "AIDS Vaccines", "HIV Seronegativity", "Avipoxvirus", "HIV Preventive Vaccine"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Evans TG, Keefer MC, Wolff M, Weinhold K, Excler JL, Duliege AM, McNamara J, McElrath JM, Graham BJ, Clements ML, Mulligan M, Belshe RB, Tartaglia J. Immunization of HIV-1 non-infected volunteers with a canarypox recombinant containing HIV-1 env, gag, pol, and nef genes (vCP 300) given simultaneously or followed by recombinant HIV-1 SF2 gp120. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:204 (abstract no 754)"}, {"pmid"=>"10580197", "type"=>"BACKGROUND", "citation"=>"Gorse GJ, Patel GB, Mandava MD, Belshe RB. Vaccine-induced cytotoxic T lymphocytes against human immunodeficiency virus type 1 using two complementary in vitro stimulation strategies. Vaccine. 1999 Dec 10;18(9-10):835-49. doi: 10.1016/s0264-410x(99)00323-0."}, {"type"=>"BACKGROUND", "citation"=>"Evans T, Corey L, Clements-Mann ML, Weinhold K, Belshe RB, Excler JL, Duliege AM. CD8+ CTL induced in AIDS vaccine evaluation group phase I trials using canarypox vectors (ALVAC) encoding multiple HIV gene products (vCP125, vCP205, vCP300) given with or without subunit boost. Int Conf AIDS. 1998;12:277 (abstract no 495/21192)"}, {"type"=>"BACKGROUND", "citation"=>"Castillo RC, Arango-Jaramllo S, Humphrey W, Weinhold K, Schwartz DH. Vaccine induced CTL activity correlates with resistant phenotype in an in vitro challenge system. Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:95 (abstract no 91)"}, {"pmid"=>"10395842", "type"=>"BACKGROUND", "citation"=>"Evans TG, Keefer MC, Weinhold KJ, Wolff M, Montefiori D, Gorse GJ, Graham BS, McElrath MJ, Clements-Mann ML, Mulligan MJ, Fast P, Walker MC, Excler JL, Duliege AM, Tartaglia J. A canarypox vaccine expressing multiple human immunodeficiency virus type 1 genes given alone or with rgp120 elicits broad and durable CD8+ cytotoxic T lymphocyte responses in seronegative volunteers. J Infect Dis. 1999 Aug;180(2):290-8. doi: 10.1086/314895."}, {"type"=>"BACKGROUND", "citation"=>"Sabbaj S, Corey L, Evans T, Keefer M, Excler JL, Duliege AM, Mulligan MJ, McGhee JR. Cytokine profiles in human PBMC T cell cultures stimulated with HIV antigens in seronegative volunteers immunized with canarypox expressing HIV antigens and boosted with recombinant SF2 GP120. Conf Adv AIDS Vaccine Dev. 1997 May 4-7:215 (Poster 110)"}, {"type"=>"BACKGROUND", "citation"=>"Kaslow RA, Rivers C, Goepfert P, Tang J, El Habib R, Weinhold K, Mulligan MJ. Association of HLA class I alleles with cytotoxic T-lymphocyte (CTL) responses to gag and env in recipients of ALVAC-HIV canarypox vaccines. 7th Conference on Retroviruses and Opportunistic Infections. 2000 Jan 30-Feb 2 [Poster 818]"}, {"type"=>"BACKGROUND", "citation"=>"Bender TJ, Tang J, Rivers C, Mulligan MJ, Kaslow RA. Grouping by HLA class I supertype does not enhance HLA associations with CTL responses to ALVAC-HIV canarypox vaccine components. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 193)"}]}, "descriptionModule"=>{"briefSummary"=>"To evaluate, in HIV-negative volunteers, the safety and immunogenicity of ALVAC-HIV MN120TMGNP (vCP300) followed by or combined with boosting using rgp120/HIV-1SF2. To compare ALVAC-HIV vCP300 with ALVAC-RG rabies glycoprotein (vCP65) as a control. To evaluate an accelerated immunization schedule at 0, 1, 3, and 6 months versus 0, 1, 6, and 9 months.\n\nThe combination of a live recombinant primer followed by a subunit boost has the potential to induce not only cytotoxic T lymphocytes but also neutralizing antibody.", "detailedDescription"=>"The combination of a live recombinant primer followed by a subunit boost has the potential to induce not only cytotoxic T lymphocytes but also neutralizing antibody.\n\nVolunteers are randomized to one of seven groups to receive immunizations with either ALVAC-HIV vCP300 or ALVAC-RG vCP65 (control), plus simultaneous or sequential boosting with rgp120/HIV-1SF2 or placebo. Immunizations are given at 0, 1, 6, and 9 months or 0, 1, 3, and 6 months. Volunteers are followed for at least 24 months."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria\n\nVolunteers must have:\n\n* Normal history and physical exam.\n* ELISA and Western blot negative for HIV.\n* CD4 count \\>= 400 cells/mm3.\n* Normal urine dipstick with esterase and nitrite.\n* Lower risk sexual behavior.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nSubjects with the following symptoms or conditions are excluded:\n\n* Positive hepatitis B surface antigen.\n* Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.\n* Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (\\> 6 months) treated infection are eligible.\n* Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.\n* Allergy to egg products or neomycin.\n\nSubjects with the following prior conditions are excluded:\n\n* History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.\n* History of anaphylaxis or other serious adverse reactions to vaccines.\n* Prior immunization against rabies.\n* History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).\n* Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.\n* History of cancer unless there has been surgical excision that is considered to have achieved cure.\n\nPrior Medication:\n\nExcluded:\n\n* Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations.\n* Experimental agents within 30 days prior to study entry.\n* Prior HIV vaccines.\n* Prior rabies immunization.\n\nPrior Treatment:\n\nExcluded:\n\n* Blood products or immunoglobulin within 6 months prior to study entry. Identifiable high-risk behavior for HIV infection, such as\n* injection drug use within past 12 months.\n* higher or intermediate risk sexual behavior."}, "identificationModule"=>{"nctId"=>"NCT00001072", "briefTitle"=>"A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP300 and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Adult Volunteers", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP300 and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Adult Volunteers", "orgStudyIdInfo"=>{"id"=>"AVEG 026"}, "secondaryIdInfos"=>[{"id"=>"10576", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"ALVAC-HIV MN120TMGNP (vCP300)", "type"=>"BIOLOGICAL"}, {"name"=>"ALVAC-RG Rabies Glycoprotein (vCP65)", "type"=>"BIOLOGICAL"}, {"name"=>"rgp120/HIV-1 SF-2", "type"=>"BIOLOGICAL"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35294", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"UAB AVEG", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"JHU AVEG", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"63104", "city"=>"Saint Louis", "state"=>"Missouri", "country"=>"United States", "facility"=>"St. Louis Univ. School of Medicine AVEG", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}, {"zip"=>"14642", "city"=>"Rochester", "state"=>"New York", "country"=>"United States", "facility"=>"Univ. of Rochester AVEG", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}, {"zip"=>"37232", "city"=>"Nashville", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Vanderbilt Univ. Hosp. AVEG", "geoPoint"=>{"lat"=>36.16589, "lon"=>-86.78444}}, {"zip"=>"98144", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"UW - Seattle AVEG", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}], "overallOfficials"=>[{"name"=>"Keefer M", "role"=>"STUDY_CHAIR"}, {"name"=>"Evans T", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}