Nctid:
NCT00001906
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007896", "term"=>"Leishmaniasis"}, {"id"=>"D016773", "term"=>"Leishmaniasis, Cutaneous"}], "ancestors"=>[{"id"=>"D056986", "term"=>"Euglenozoa Infections"}, {"id"=>"D011528", "term"=>"Protozoan Infections"}, {"id"=>"D010272", "term"=>"Parasitic Diseases"}, {"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D012876", "term"=>"Skin Diseases, Parasitic"}, {"id"=>"D000079426", "term"=>"Vector Borne Diseases"}, {"id"=>"D012874", "term"=>"Skin Diseases, Infectious"}, {"id"=>"D012871", "term"=>"Skin Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M10908", "name"=>"Leishmaniasis", "asFound"=>"Leishmaniasis", "relevance"=>"HIGH"}, {"id"=>"M19130", "name"=>"Leishmaniasis, Cutaneous", "asFound"=>"Cutaneous Leishmaniasis", "relevance"=>"HIGH"}, {"id"=>"M13185", "name"=>"Parasitic Diseases", "relevance"=>"LOW"}, {"id"=>"M28673", "name"=>"Euglenozoa Infections", "relevance"=>"LOW"}, {"id"=>"M14388", "name"=>"Protozoan Infections", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"M15679", "name"=>"Skin Diseases, Parasitic", "relevance"=>"LOW"}, {"id"=>"M2054", "name"=>"Vector Borne Diseases", "relevance"=>"LOW"}, {"id"=>"M15677", "name"=>"Skin Diseases, Infectious", "relevance"=>"LOW"}, {"id"=>"T3368", "name"=>"Leishmaniasis", "asFound"=>"Leishmaniasis", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D018664", "term"=>"Interleukin-12"}, {"id"=>"D000536", "term"=>"Aluminum Hydroxide"}], "ancestors"=>[{"id"=>"D000276", "term"=>"Adjuvants, Immunologic"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D020533", "term"=>"Angiogenesis Inhibitors"}, {"id"=>"D043924", "term"=>"Angiogenesis Modulating Agents"}, {"id"=>"D006133", "term"=>"Growth Substances"}, {"id"=>"D006131", "term"=>"Growth Inhibitors"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000863", "term"=>"Antacids"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D005765", "term"=>"Gastrointestinal Agents"}], "browseLeaves"=>[{"id"=>"M17360", "name"=>"Vaccines", "relevance"=>"LOW"}, {"id"=>"M20747", "name"=>"Interleukin-12", "asFound"=>"Pegylated interferon alfa-", "relevance"=>"HIGH"}, {"id"=>"M3877", "name"=>"Aluminum Hydroxide", "asFound"=>"Tobramycin", "relevance"=>"HIGH"}, {"id"=>"M257732", "name"=>"Aluminum sulfate", "relevance"=>"LOW"}, {"id"=>"M3628", "name"=>"Adjuvants, Immunologic", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M22318", "name"=>"Angiogenesis Inhibitors", "relevance"=>"LOW"}, {"id"=>"M9231", "name"=>"Growth Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4188", "name"=>"Antacids", "relevance"=>"LOW"}, {"id"=>"M4219", "name"=>"Anti-Ulcer Agents", "relevance"=>"LOW"}, {"id"=>"M8881", "name"=>"Gastrointestinal Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>50}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1999-04"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2000-04", "completionDateStruct"=>{"date"=>"2001-05"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"2002-12-09", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2002-12-10", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Alum", "Antigen", "Cytokine", "Parasitic Infection", "Phase I", "Cutaneous Leishmaniasis"], "conditions"=>["Cutaneous Leishmaniasis"]}, "referencesModule"=>{"references"=>[{"pmid"=>"4253634", "type"=>"BACKGROUND", "citation"=>"Guirges SY. Natural and experimental re-infection of man with Oriental sore. Ann Trop Med Parasitol. 1971 Jun;65(2):197-205. doi: 10.1080/00034983.1971.11686746. No abstract available."}, {"pmid"=>"5048790", "type"=>"BACKGROUND", "citation"=>"Naggan L, Gunders AE, Michaeli D. Follow-up study of a vaccination programme against cutaneous leishmaniasis. II. Vaccination with a recently isolated strain of L. tropica from Jericho. Trans R Soc Trop Med Hyg. 1972;66(2):239-43. doi: 10.1016/0035-9203(72)90153-8. No abstract available."}, {"pmid"=>"2657601", "type"=>"BACKGROUND", "citation"=>"Modabber F. Experiences with vaccines against cutaneous leishmaniasis: of men and mice. Parasitology. 1989;98 Suppl:S49-60. doi: 10.1017/s0031182000072243."}]}, "descriptionModule"=>{"briefSummary"=>"While vaccination against cutaneous leishmaniasis, a chronic ulcerating protozoan infection of the skin, has been possible for decades using live parasites, the production and storage of live cultures are difficult. Since inoculation occasionally leads to severe infection, most experts now advocate against their use. We have shown excellent protection using a \"heat-killed\" vaccine that combines autoclaved leishmania antigen with recombinant human interleukin-12 (rhIL-12) and aluminum hydroxide gel as adjuvants in a rhesus macaque model of disease. To assess the safety and immunogenicity of this vaccine in humans, we now propose a rhIL-12 dose escalation Phase I/II trial.", "detailedDescription"=>"While vaccination against cutaneous leishmaniasis, a chronic ulcerating protozoan infection of the skin, has been possible for decades using live parasites, the production and storage of live cultures are difficult. Since inoculation occasionally leads to severe infection, most experts now advocate against their use. We have shown excellent protection using a \"heat-killed\" vaccine that combines autoclaved leishmania antigen with recombinant human interleukin-12 (rhIL-12) and aluminum hydroxide gel as adjuvants in a rhesus macaque model of disease. To assess the safety and immunogenicity of this vaccine in humans, we now propose a rhIL-12 dose escalation Phase I/II trial."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>true, "eligibilityCriteria"=>"Male or non-pregnant female 18 - 50 years of age at the time of screening and willing to use effective birth control for one month post vaccination.\n\nFree of obvious health problems as established by medical history and clinical examination before entering into the study.\n\nAvailable to participate for the duration of the study (approximately 6 months).\n\nAble to give signed informed consent.\n\nMay not have received an investigational leishmania vaccine or skin test, or recombinant human interleukin-12.\n\nNo use of an investigational drug or any vaccine other than the study vaccine within 30 days preceding the dose, or planned use during the study period.\n\nNo administration of chronic immunosuppressants (defined as more than 14 days) or other immune-modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisone, or equivalent, greater than 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)\n\nNo history of prior leishmaniasis or of extensive travel to regions endemic for leishmaniasis, such as southern Mexico, Central and most of South America, the Mediterranean region and Middle East, Africa, and India.\n\nNo confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.\n\nNo family history of congenital or hereditary immunodeficiency.\n\nNo history of significant allergic disease or reactions likely to be exacerbated by any component.\n\nNo acute disease at the time of enrollment, defined as the presence of a moderate or severe illness with or without fever.\n\nNo acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal function abnormality, as determined by physical examination or laboratory screening tests.\n\nNo pregnant or lactating females.\n\nMust not have suspected or known alcohol or drug abuse.\n\nNo other significant finding that, in the opinion of the investigator, would increase the risk of having an adverse outcome from participating in this study."}, "identificationModule"=>{"nctId"=>"NCT00001906", "briefTitle"=>"Safety and Immunogenicity of a Vaccine for Cutaneous Leishmaniasis Using Recombinant Human Interleukin-12 and Aluminum Hydroxide Gel as Adjuvants", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Safety and Immunogenicity of a Vaccine for Cutaneous Leishmaniasis Using Recombinant Human Interleukin-12 and Aluminum Hydroxide Gel as Adjuvants", "orgStudyIdInfo"=>{"id"=>"990091"}, "secondaryIdInfos"=>[{"id"=>"99-I-0091"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Combination of autoclaved leishmania antigen with recombinant human interleukin-12 (rhIL-12) and aluminum hydroxide gel as adjuvants", "type"=>"BIOLOGICAL"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}}}}
