Nctid:
NCT00000815
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008457", "term"=>"Measles"}], "ancestors"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D012327", "term"=>"RNA Virus Infections"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D018185", "term"=>"Morbillivirus Infections"}, {"id"=>"D018184", "term"=>"Paramyxoviridae Infections"}, {"id"=>"D018701", "term"=>"Mononegavirales Infections"}], "browseLeaves"=>[{"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M11440", "name"=>"Measles", "asFound"=>"Measles", "relevance"=>"HIGH"}, {"id"=>"M15229", "name"=>"Rubella", "relevance"=>"LOW"}, {"id"=>"M12064", "name"=>"Mumps", "relevance"=>"LOW"}, {"id"=>"M3735", "name"=>"AIDS-Related Complex", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M20330", "name"=>"Paramyxoviridae Infections", "relevance"=>"LOW"}, {"id"=>"M20778", "name"=>"Mononegavirales Infections", "relevance"=>"LOW"}, {"id"=>"T3653", "name"=>"Measles", "asFound"=>"Measles", "relevance"=>"HIGH"}, {"id"=>"T5072", "name"=>"Rubella", "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"}, {"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M17360", "name"=>"Vaccines", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>270}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"2001-08", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-27", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-10-28", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Comparison of measles seroconversion rates at 13 months of age between HIV-infected children vaccinated at 12 months of age and HIV-infected children vaccinated at 6 and 12 months of age", "timeFrame"=>"Throughout study"}, {"measure"=>"Comparison of seroconversion rates at 13 months of age (following second vaccination) of HIV-uninfected children with HIV-infected children.", "timeFrame"=>"Throughout study"}, {"measure"=>"Comparison of seroconversion rates at 13 months of age (following single vaccination) of HIV-uninfected children with HIV-infected children following vaccination at 12 months of age", "timeFrame"=>"Throughout study"}], "secondaryOutcomes"=>[{"measure"=>"Comparison of measles seroconversion rates in HIV-infected children vaccinated at 6 months of age with HIV-infected children vaccinated at 12 months of age", "timeFrame"=>"Throughout study"}, {"measure"=>"Assessment of measles antibody decay and persistence in HIV-infected and HIV-unifected vaccinees", "timeFrame"=>"Throughout study"}, {"measure"=>"Evaluation of adverse effects and immune reactions to vaccine in HIV-infected children and HIV-uninfected vaccinees", "timeFrame"=>"Throughout study"}]}, "conditionsModule"=>{"keywords"=>["Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Measles-Mumps-Rubella Vaccine", "Vaccines, Attenuated", "Measles Vaccine", "Immunization Schedule", "Measles Virus", "Measles"], "conditions"=>["HIV Infections", "Measles"]}, "referencesModule"=>{"references"=>[{"pmid"=>"21666159", "type"=>"RESULT", "citation"=>"Chandwani S, Beeler J, Li H, Audet S, Smith B, Moye J, Nalin D, Krasinski K; PACTG 225 Study Team. Safety and immunogenicity of early measles vaccination in children born to HIV-infected mothers in the United States: results of Pediatric AIDS Clinical Trials Group (PACTG) protocol 225. J Infect Dis. 2011 Jul;204 Suppl 1(Suppl 1):S179-89. doi: 10.1093/infdis/jir089."}]}, "descriptionModule"=>{"briefSummary"=>"To compare measles seroconversion rates (development of antibodies) at 13 months of age in HIV-infected and uninfected children on one of two immunization schedules: attenuated measles/mumps/rubella virus (M-M-R II) vaccine at 12 months versus attenuated measles vaccine (Attenuvax) at 6 months plus M-M-R II vaccine at 12 months.\n\nRecommendations for the age at vaccination should balance the need to minimize the risk of morbidity and mortality with the benefit of achieving the highest seroconversion rates. Immunizing a more intact immune system at an earlier stage of HIV infection may in turn achieve better and long-lasting measles protection. This study will help define a more effective measles vaccine regimen for children diagnosed with HIV infection and will provide greater insight into the functional status of the HIV-infected children's humoral immune system.", "detailedDescription"=>"Recommendations for the age at vaccination should balance the need to minimize the risk of morbidity and mortality with the benefit of achieving the highest seroconversion rates. Immunizing a more intact immune system at an earlier stage of HIV infection may in turn achieve better and long-lasting measles protection. This study will help define a more effective measles vaccine regimen for children diagnosed with HIV infection and will provide greater insight into the functional status of the HIV-infected children's humoral immune system.\n\nPatients, HIV infected and uninfected, are randomized to one of two attenuated measles vaccine schedules: at 6 and 12 months of age, or at 12 months of age only. Attenuvax is administered as the month 6 vaccine and M-M-R II as the month 12 vaccine. Patients are followed for 24 months after the last vaccination."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"7 months", "minimumAge"=>"6 months", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* Willing to have and receive results of HIV test\n* Been born to mothers with HIV infection or history of AIDS-defining condition by CDC criteria.\n* No history of opportunistic infection.\n* No known exposure to measles within 14 days prior to study entry.\n* CD4+ lymphocyte count \\>= 750 cells/mm3 or more than 15% at 6 months of age.\n* Parent or legal guardian available to give written informed consent and be willing to comply with all study requirements.\n* Childhood immunizations (other than measles) according to current recommendations of the Immunization Practice Advisory Committee and American Academy of Pediatrics.\n\nNOTE:\n\n* Coenrollment on other therapeutic protocols (except for ACTG 185) is permitted.\n\nNOTE:\n\n* Patients must be located in a geographical area where measles immunization at 12 months is standard of care.\n\nRecommended:\n\n* Childhood immunizations other than measles according to current guidelines.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Intercurrent illness and/or fever for 7 days.\n* Known sensitivity or allergy to neomycin or eggs.\n\nConcurrent Medication:\n\nExcluded:\n\n* IVIG.\n* Uninterrupted or anticipated steroid therapy (\\>= 2 mg/kg/day) for more than 2 weeks duration.\n\nPatients with the prior condition are excluded:\n\n* Platelet count \\< 50,000/mm3 at any time prior to study entry.\n\nPrior Medication:\n\nExcluded:\n\n* Any IgG preparation within the past 6 months."}, "identificationModule"=>{"nctId"=>"NCT00000815", "briefTitle"=>"A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group", "orgStudyIdInfo"=>{"id"=>"ACTG 225"}, "secondaryIdInfos"=>[{"id"=>"11202", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"1", "description"=>"Participants who receive vaccination at 6 and 12 months of age", "interventionNames"=>["Biological: Attenuvax", "Biological: M-M-R-II"]}, {"type"=>"EXPERIMENTAL", "label"=>"2", "description"=>"Participants who receive vaccination only at 12 months of age", "interventionNames"=>["Biological: M-M-R-II"]}], "interventions"=>[{"name"=>"Attenuvax", "type"=>"BIOLOGICAL", "description"=>"Measles virus vaccine (attenuate)administered subcutaneously at a single dose of 0.5 mL at 6 months of age", "armGroupLabels"=>["1"]}, {"name"=>"M-M-R-II", "type"=>"BIOLOGICAL", "description"=>"Measles-Mumps-Rubella vaccine (attenuated)administered subcutaneously as a single dose of 0.5 mL at 12 months of age", "armGroupLabels"=>["1", "2"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35233", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"UAB, Dept. of Ped., Div. of Infectious Diseases", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"90801", "city"=>"Long Beach", "state"=>"California", "country"=>"United States", "facility"=>"Long Beach Memorial Med. Ctr., Miller Children's Hosp.", "geoPoint"=>{"lat"=>33.76696, "lon"=>-118.18923}}, {"zip"=>"90033", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Usc La Nichd Crs", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"94609", "city"=>"Oakland", "state"=>"California", "country"=>"United States", "facility"=>"Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.", "geoPoint"=>{"lat"=>37.80437, "lon"=>-122.2708}}, {"city"=>"San Diego", "state"=>"California", "country"=>"United States", "facility"=>"UCSD Maternal, Child, and Adolescent HIV CRS", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"city"=>"Torrance", "state"=>"California", "country"=>"United States", "facility"=>"Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases", "geoPoint"=>{"lat"=>33.83585, "lon"=>-118.34063}}, {"city"=>"Aurora", "state"=>"Colorado", "country"=>"United States", "facility"=>"Univ. of Colorado Denver NICHD CRS", "geoPoint"=>{"lat"=>39.72943, "lon"=>-104.83192}}, {"zip"=>"06504", "city"=>"New Haven", "state"=>"Connecticut", "country"=>"United States", "facility"=>"Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease", "geoPoint"=>{"lat"=>41.30815, "lon"=>-72.92816}}, {"zip"=>"20010", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Children's National Med. Ctr., ACTU", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"20060", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Howard Univ. Washington DC NICHD CRS", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"city"=>"Jacksonville", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ. of Florida Jacksonville NICHD CRS", "geoPoint"=>{"lat"=>30.33218, "lon"=>-81.65565}}, {"zip"=>"30306", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Cook County Hosp.", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60614", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Chicago Children's CRS", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Tulane/LSU Maternal/Child CRS", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"HMS - Children's Hosp. Boston, Div. of Infectious Diseases", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"48201", "city"=>"Detroit", "state"=>"Michigan", "country"=>"United States", "facility"=>"Children's Hospital of Michigan NICHD CRS", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"city"=>"New Brunswick", "state"=>"New Jersey", "country"=>"United States", "facility"=>"UMDNJ - Robert Wood Johnson", "geoPoint"=>{"lat"=>40.48622, "lon"=>-74.45182}}, {"city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"NJ Med. School CRS", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"07503", "city"=>"Paterson", "state"=>"New Jersey", "country"=>"United States", "facility"=>"St. Joseph's Hosp. & Med. Ctr. of New Jersey", "geoPoint"=>{"lat"=>40.91677, "lon"=>-74.17181}}, {"zip"=>"12208", "city"=>"Albany", "state"=>"New York", "country"=>"United States", "facility"=>"Children's Hospital at Albany Medical Center, Dept. of Peds.", "geoPoint"=>{"lat"=>42.65258, "lon"=>-73.75623}}, {"zip"=>"11021", "city"=>"Great Neck", "state"=>"New York", "country"=>"United States", "facility"=>"North Shore-Long Island Jewish Health System, Dept. of Peds.", "geoPoint"=>{"lat"=>40.80066, "lon"=>-73.72846}}, {"zip"=>"11040", "city"=>"New Hyde Park", "state"=>"New York", "country"=>"United States", "facility"=>"Schneider Children's Hosp., Div. of Infectious Diseases", "geoPoint"=>{"lat"=>40.7351, "lon"=>-73.68791}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"NYU Med. Ctr., Dept. of Medicine", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10029", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Metropolitan Hosp. Ctr.", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10029", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Metropolitan Hosp. NICHD CRS", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10032", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Columbia IMPAACT CRS", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10032", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Incarnation Children's Ctr.", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10037", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Harlem Hosp. Ctr. NY NICHD CRS", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"city"=>"Rochester", "state"=>"New York", "country"=>"United States", "facility"=>"Strong Memorial Hospital Rochester NY NICHD CRS", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}, {"city"=>"Stony Brook", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY Stony Brook NICHD CRS", "geoPoint"=>{"lat"=>40.92565, "lon"=>-73.14094}}, {"zip"=>"13210", "city"=>"Syracuse", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY Upstate Med. Univ., Dept. of Peds.", "geoPoint"=>{"lat"=>43.04812, "lon"=>-76.14742}}, {"zip"=>"27710", "city"=>"Durham", "state"=>"North Carolina", "country"=>"United States", "facility"=>"DUMC Ped. CRS", "geoPoint"=>{"lat"=>35.99403, "lon"=>-78.89862}}, {"city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"The Children's Hosp. of Philadelphia IMPAACT CRS", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"city"=>"Charleston", "state"=>"South Carolina", "country"=>"United States", "facility"=>"Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases", "geoPoint"=>{"lat"=>32.77657, "lon"=>-79.93092}}, {"city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Texas Children's Hosp. CRS", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"23507", "city"=>"Norfolk", "state"=>"Virginia", "country"=>"United States", "facility"=>"Childrens Hosp. of the Kings Daughters", "geoPoint"=>{"lat"=>36.84681, "lon"=>-76.28522}}, {"city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"UW School of Medicine - CHRMC", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}, {"city"=>"Bayamon", "country"=>"Puerto Rico", "facility"=>"Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.", "geoPoint"=>{"lat"=>18.39856, "lon"=>-66.15572}}, {"city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"San Juan City Hosp. PR NICHD CRS", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}, {"city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}], "overallOfficials"=>[{"name"=>"Chandwani S", "role"=>"STUDY_CHAIR"}, {"name"=>"Krasinski K", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Merck Sharp & Dohme LLC", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
