[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558077":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":30,"locations":45,"responsibleParty":88,"collaborators":90,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":30,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":30,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":30,"overallStatus":118,"whyStopped":30,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"B\u002FHPIV3\u002FHMPV-PreF-A vaccine","ACTIVE_COMPARATOR","A single dose of intranasal B\u002FHPIV3\u002FHMPV-PreF-A will be administered by a Vax300 VaxINator atomization device.",[13],"Biological: B\u002FHPIV3\u002FHMPV-PreF-A vaccine",{"label":15,"type":10,"description":16,"interventionNames":17},"B\u002FHPIV3\u002FHMPV-F-B365 vaccine","A single dose of intranasal B\u002FHPIV3\u002FHMPV-F-B365 will be administered by a Vax300 VaxINator atomization device.",[18],"Biological: B\u002FHPIV3\u002FHMPV-F-B365 vaccine",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR","A single dose of intranasal Lactated Ringer's Solution for Injection will be administered by a Vax300 VaxINator atomization device.",[24],"Drug: Placebo",[26,31,34],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","B\u002FHPIV3\u002FHMPV-PreF-A is a live-attenuated vaccine candidate. The B\u002FHPIV3\u002FHMPV-PreF-A vaccine is provided in a sterile 2.0-mL cryovial, each containing 0.6 mL of vaccine with a titer of approximately 10\\^6.7 PFU\u002FmL. The vaccine virus concentrate is diluted with Lactated Ringer's Solution for Injection to a dose of approximately 10\\^5.6 PFU in a 0.2 mL volume.",[9],null,{"type":27,"name":15,"description":32,"armGroupLabels":33,"otherNames":30},"B\u002FHPIV3\u002FHMPV-F-B365 is a live-attenuated vaccine candidate. The B\u002FHPIV3\u002FHMPV-F-B365 vaccine is provided in a sterile 2.0-mL cryovial, each containing 0.6 mL of vaccine with a titer of approximately 10\\^6.3 PFU\u002FmL. The vaccine virus concentrate is diluted with Lactated Ringer's Solution for Injection to a dose of approximately 10\\^5.6 PFU in a 0.2 mL volume.",[15],{"type":35,"name":20,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Lactated Ringer's Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment. It will be drawn up in a sterile syringe to a volume of 0.2 mL.",[20],[39],"Lactated Ringer's Solution for Injection",[41],{"name":42,"affiliation":43,"role":44},"Ruth Karron, M.D.","Center for Immunization Research, JHBSPH","PRINCIPAL_INVESTIGATOR",[46,59,68,78],{"facility":47,"status":30,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":30},"CIR - Rangos, Johns Hopkins Bloomberg School of Public Health","Baltimore","Maryland","21205","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-76.61219,39.29038,{"lat":57,"lon":56},{"facility":60,"status":30,"city":61,"state":49,"zip":62,"country":51,"countryCode":52,"cosmosGeoPoint":63,"geoPoint":67,"contacts":30},"CIR South","Columbia","21045",{"type":54,"coordinates":64},[65,66],-76.83942,39.24038,{"lat":66,"lon":65},{"facility":69,"status":30,"city":70,"state":71,"zip":72,"country":51,"countryCode":52,"cosmosGeoPoint":73,"geoPoint":77,"contacts":30},"University of Rochester Medical Center","Rochester","New York","14642",{"type":54,"coordinates":74},[75,76],-77.61556,43.15478,{"lat":76,"lon":75},{"facility":79,"status":30,"city":80,"state":81,"zip":82,"country":51,"countryCode":52,"cosmosGeoPoint":83,"geoPoint":87,"contacts":30},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":54,"coordinates":84},[85,86],-86.78444,36.16589,{"lat":86,"lon":85},{"type":89,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[91,94,95],{"name":92,"class":93},"Johns Hopkins Bloomberg School of Public Health","OTHER",{"name":79,"class":93},{"name":96,"class":93},"University of Rochester","100558077","phase-1-study-of-the-infectivity-safety-and-immunogenicity-of-two-recombinant-live-attenuated-bhpiv3-vectored-vaccines-expressing-the-fusion-glycoprotein-of-hmpv-delivered-by-nasal-spray-to-hpiv3-seropositive-children-24-to-60-months-of-age-100558077",false,"NCT06546423","Study of the Infectivity, Safety and Immunogenicity of Two Recombinant, Live-Attenuated, B\u002FHPIV3 Vectored Vaccines Expressing the Fusion Glycoprotein of HMPV Delivered by Nasal Spray to HPIV3-Seropositive Children 24 to \u003C60 Months of Age","Phase I Study of the Infectivity, Safety and Immunogenicity of Two Recombinant, Live-Attenuated, Bovine\u002FHuman, Parainfluenza Virus Type 3 (B\u002FHPIV3) Vectored Vaccines Expressing the Fusion Glycoprotein of Human Metapneumovirus (HMPV), Delivered by Nasal Spray to HPIV3-Seropositive Children 24 to \u003C60 Months of Age","Inclusion Criteria:\n\n* ≥24 months of age and \\\u003C60 months of age at the time of inoculation\n* HAI Screening for HPIV3-neutralizing antibody is obtained within the calendar year of inoculation\n* Seropositive for HPIV3 antibody, defined as serum HPIV3 HAI titer \\>1:8\n* Pre-inoculation serum sample for HPIV3-neutralizing antibody specimen is obtained no more than 42 days prior to inoculation\n* In good health based on review of the medical record, history, and physical examination at the time of inoculation\n* Received routine immunizations appropriate for age based on the Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger\n* Growing normally for age as demonstrated on a World Health Organization (WHO) growth chart, AND has a current height and weight above the 3rd percentile for age\n* Expected to be available for the duration of the study\n* Parent\u002Fguardian is willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* \\\u003C24 months of age and \\>60 months of age at the time of inoculation.\n* Born at less than 34 weeks gestation\n* Maternal history of a positive HIV test before or during pregnancy.\n* Evidence of chronic disease\n* Known or suspected infection or impairment of immunological functions\n* Bone marrow\u002Fsolid organ transplant recipient\n* Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities\n* Suspected or documented developmental disorder, delay, or other developmental problem\n* Cardiac abnormality requiring treatment\n* Lung disease or reactive airway disease\n* More than one episode of medically diagnosed wheezing in the first year of life\n* Wheezing episode or received bronchodilator therapy or racemic epinephrine within the past 12 months\n* Wheezing episode or received bronchodilator therapy after the age of 12 months\n* Previous receipt of supplemental oxygen therapy in a home setting\n* Previous receipt of an investigational HPIV3 or HMPV vaccine\n* Previous receipt or planned administration of human immunoglobulin within the past 6 months. Receipt of licensed monoclonal antibody products for passive prophylaxis against RSV (e.g., nirsevimab) within the past 6 months is not a cause for exclusion\n* Previous receipt of any blood products within the past 6 months.\n* Previous anaphylactic reaction\n* Previous vaccine-associated adverse reaction that was Grade 3 or above.\n* Known hypersensitivity to any study product component\n* Member of a household that contains an infant who is less than 12 months of age at the date of inoculation through the 10th day after inoculation\n* Member of a household that, at the date of inoculation through the 10th day after inoculation, contains an immunocompromised individual including but not limited to:\n\n  * a person who is HIV-infected\n  * a person who has cancer and has received chemotherapy within the 12 months prior to enrollment\n  * a person living with a solid organ or bone marrow transplant\n* Attends a daycare facility that does not separate children by age and contains a child \\\u003C12 months of age at the date of inoculation through the 10th day after inoculation\n* Receipt of any of the following prior to enrollment:\n\n  * inactivated influenza vaccine within 3 days prior, or\n  * any other inactivated vaccine, messenger RNA (mRNA) vaccine, or live-attenuated rotavirus vaccine within the 14 days prior, or\n  * any live vaccine, other than rotavirus vaccine, within the 28 days prior, or\n  * another investigational vaccine or investigational drug within 28 days prior, or\n  * salicylate (aspirin) or salicylate-containing products within the past 28 days\n* Scheduled administration of any of the following after planned inoculation:\n\n  * inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days after, or\n  * any live vaccine other than rotavirus within the 28 days after, or\n  * any salicylate or salicylate-containing products within the 28 days after, or\n  * another investigational vaccine or investigational drug in the 56 days after\n* Receipt of any of the following medications within 3 days prior to study enrollment:\n\n  * systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or\n  * intranasal medications, or\n  * other prescription medications except the permitted concomitant medications listed below\n  * Permitted concomitant medications (prescription or non-prescription) include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) cutaneous (topical) steroids, topical antibiotics, and topical antifungal agents\n* Any of the following events at the time of enrollment:\n\n  * fever (temporal or rectal temperature of ≥100.4°F), or\n  * upper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis), or\n  * nasal congestion significant enough to interfere with successful inoculation, or\n  * otitis media, or\n  * contact with a person diagnosed with COVID-19 disease or active SARS-CoV-2 infection within the preceding 10 days",true,"ALL","24 Months","59 Months",{"count":109,"type":110},24,"ACTUAL","INTERVENTIONAL",[113],"PHASE1","HPIV3 and HMPV are viruses that can cause breathing problems in children. The goal of this clinical trial is to look at the safety of 2 experimental HPIV3\u002FHMPV vaccines in HPIV3-seropositive children ≥ 24 months to \\\u003C 60 months of age. Children will receive B\u002FHPIV3\u002FHMPV-PreF-A vaccine, B\u002FHPIV3\u002FHMPV-F-B365 vaccine, or placebo, and participants will not know which study product they have received.\n\nThe main goals of the study are to find out whether these vaccines are well-tolerated and infectious in HPIV3-seropositive children.\n\nThe general procedures include daily temperature measurements and daily contact with the participant for the first 28 days, giving a single dose of one of the 2 study vaccines or placebo delivered by nasal sprayer, about 9 in-person visits, a physical examination, 7 clinical assessments, 2 blood samples, 9 nasal swabs and monthly contacts with the participant between Days 29-180.\n\nAdditional visits may occur if the child has a respiratory illness, fever, or ear infections. The illness visit will include a nasal swab and a clinical assessment.",[116,117],"Human Metapneumovirus","Human Parainfluenza Virus Type 3","COMPLETED","2026-04-13",{"date":121,"type":110},"2026-04-16",{"date":123,"type":110},"2024-07-12",{"date":125,"type":110},"2025-06-04",{"name":5,"class":6},4]