[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Blue Lake Biotechnology Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100489596","phase-1-a-study-of-blb-201-rsv-vaccine-in-infants-and-children-100489596",false,"NCT05655182","A Study of BLB-201 RSV Vaccine in Infants and Children","A Phase 1\u002F2a Trial of the Safety, Tolerability and Immunogenicity of PIV5-vectored RSV Vaccine (BLB-201) in RSV Seronegative and Seropositive Infants and Children","Inclusion criteria for sero+ children 18 to 59 months of age enrolled in Groups 1 and 2:\n\nHealthy children at least 18 months but less than 60 months of age whose legally-acceptable representative (LAR) understands and signs the trial informed consent and agrees to vaccine administration following a detailed explanation of the trial.\n\nDetermined by medical history, targeted physical exam, and clinical judgement of the investigator to be in a good state of health. Screening laboratory values slightly outside lab normal ranges may be acceptable if the site investigator determines that they are not clinically significant. Permitted concomitant medications include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including topical steroids, topical antibiotics, and topical antifungal agents.\n\nSero+ for RSV as defined by serum RSV antibody titer assay\n\nParticipant is expected to be available for the duration of the trial.\n\nThe LAR confirms that the subject has received routine immunizations appropriate for age based on the current Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger.\n\nGrowing 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\nInclusion criteria for sero+ or sero- infants and children 8 to 24 months of age enrolled in Groups 3 through 6:\n\nHealthy children at least 8 months but less than 25 months of age whose LAR understands and signs the trial informed consent and agrees to vaccine administration following a detailed explanation of the trial.\n\nDetermined by medical history, targeted physical exam, and clinical judgement of the investigator to be in a good state of health. Screening laboratory values slightly outside lab normal ranges may be acceptable if the site investigator determines that they are not clinically significant. Permitted concomitant medications include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including topical steroids, topical antibiotics, and topical antifungal agents.\n\nSero- OR sero+ for RSV antibody, defined by serum RSV antibody titer assay not more than 30 days prior to vaccination.\n\nParticipant is expected to be available for the duration of the trial.\n\nThe LAR confirms that subject has received routine immunizations appropriate for age based on the current Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger.\n\nGrowing normally for age as demonstrated on a World Health Organization (WHO) growth chart, AND\n\nIf \\\u003C1 year of age: has a current height and weight above the 5th percentile for age.\n\nIf ≥1 year of age: has a current height and weight above the 3rd percentile for age.\n\nSubject Exclusion Criteria\n\n\\\u003C8 months of age and \\>60 months of age at the time of planned vaccine inoculation.\n\nBorn at less than 34 weeks gestation for subjects ≥ 1 year of age at enrollment\n\nBorn at less than 37 weeks gestation, and at the date of inoculation less than 1 year of age.\n\nMaternal history of a positive HIV test before or during pregnancy.\n\nMaternal history of illicit drug abuse or alcohol abuse.\n\nEvidence of chronic disease except for chronic diseases that are mild, stable and not immune compromising or require recent change (\\\u003C 60 days) in management (e.g., mild stable eczema, mild allergic rhinitis)\n\nClinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by medical history or physical exam. Abnormal pulse oximetry testing during screening for undetected critical congenital heart disease or concern for such by medical history or physical exam.\n\nAcute or chronic medical condition or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgement, make the participant inappropriate for the study.\n\nHistory of severe infection (e.g., requiring hospitalization).\n\nKnown or suspected impairment of immunological functions, bone marrow\u002Fsolid organ transplant recipients.\n\nReceiving immunosuppressive therapy including systemic corticosteroids.\n\nMajor congenital malformations, including congenital cleft palate or cytogenetic abnormalities.\n\nSuspected or documented developmental disorder, delay, or other developmental problem.\n\nCardiac abnormality requiring treatment. Participants with clinically insignificant cardiac abnormalities (e.g., clinically insignificant patent foramen ovale) requiring no treatment may be enrolled.\n\nLung disease or reactive airway disease.\n\nHistory of wheezing episode\u002Fs or receipt of bronchodilator therapy\n\nPrevious receipt of supplemental oxygen therapy in a home setting.\n\nHistory of severe RSV infection or severe respiratory virus infection (e.g., requiring hospitalization).\n\nPrevious immunization with an investigational RSV vaccine.\n\nPrevious or planned administration of any anti-RSV antibody product within 6 months of receipt of study vaccine.\n\nPrevious receipt of immunoglobulin or any other antibody products within the past 6 months.\n\nPrevious receipt of any blood products within the past 6 months.\n\nPrevious anaphylactic reaction.\n\nPrevious serious vaccine-associated adverse reaction or one that was Grade 3 or above.\n\nKnown hypersensitivity to any study vaccine product component.\n\nHousehold contact with any of the following groups of individuals for the period up to 28 days after vaccination (including after each dose for cohorts receiving two doses of vaccine):\n\nMember of a household that contains an infant who is less than 6 months of age at the date of inoculation through the 28th day after inoculation. In groups assigned to two doses of vaccine, to include date of inoculation through the 28th day after the second inoculation.\n\nPregnant woman.\n\nPersons with hospitalization for asthma or other chronic respiratory disease in the past 5 years.\n\nMember of a household that, at the date of inoculation through the 28th day after inoculation (including second dose if scheduled), contains an immunocompromised individual including but not limited to:\n\nA person who is HIV-infected.\n\nA person who has cancer and has received chemotherapy within the 12 months prior to enrollment.\n\nA person with a solid organ or bone marrow transplant.\n\nA person currently receiving immunosuppressive agents.\n\nAttends a daycare facility that does not separate children by age and contains an infant\n\n\\\u003C6 months of age at the date of inoculation through the 28th day after inoculation.\n\nNeurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).\n\nHistory of postinfectious or postvaccine neurological sequelae.\n\nAutoimmune, inflammatory, vascular, or rheumatic disease.\n\nHousehold contact of another child enrolled into the trial.\n\nInadequate venous access for repeated phlebotomy.\n\nSubject's LAR\u002Fs who, in the opinion of the site investigator, are not suitable participants for the study, for any reason not previously delineated, including subjects with any condition that would in the opinion of the site investigator place the subject at unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.\n\nSubjects testing positive for infection with RSV, Influenza, or SARS-CoV-2 in the 3 months prior to enrollment.\n\nPlanned receipt of any of the following prior to planned trial vaccine receipt (Day 1 and Day 57 for group receiving 2 doses of vaccine):\n\nInactivated influenza vaccine within 14 days prior, or\n\nAny other inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days prior, or\n\nAny live vaccine, other than rotavirus vaccine, within the 28 days prior, or\n\nAnother investigational vaccine or investigational drug within 28 days prior.\n\nSalicylate (aspirin) or salicylate-containing products within 28 days prior.\n\nPlanned receipt of any of the following after planned trial vaccine receipt (Day 1 and Day 57 for groups receiving 2 doses of vaccine):\n\nInactivated vaccine or live-attenuated rotavirus vaccine within the 14 days after, or\n\nAny live vaccine other than rotavirus in the 28 days after, or\n\nAnother investigational vaccine or investigational drug in the 56 days after.\n\nPlanned receipt of any of the following medications within 7 days of trial enrollment and 7 days after trial vaccine (Day 1 and also Day 57 for groups receiving 2 doses of vaccine):\n\nSystemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or systemic or nasal steroid therapy for acute illness.\n\nAny other intranasal medications, or\n\nOther prescription medications except permitted concomitant medications. 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\nHistory of bleeding disorder or significant problem with bleeding\n\nAmerican Indian or Alaska Native Infants\u002FChildren (high risk for severe RSV infection) AND eligible to receive nirsevimab\n\nTemporary exclusion criteria for sero+ children, sero- children, and infants:\n\nThe following are temporary or self-limiting conditions, and once resolved, the subject may be enrolled, if otherwise eligible. If the period of temporary exclusion is greater than 30 days, sero- children will need to be rescreened for levels of RSV neutralizing antibody.\n\nAny of the following events at the time of enrollment:\n\nFever (temperature of ≥100.4°F per site standard based on age; e.g., oral for older children, rectal for infants, axillary screening), or\n\nUpper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis) or\n\nNasal congestion significant enough to interfere with successful vaccination.\n\nOtitis media.\n\nContact with a person diagnosed with RSV, Influenza, coronavirus disease-2 (COVID- 19) or other viral respiratory illnesses within the preceding 10 days.",true,"ALL","6 Months","5 Years",{"count":21,"type":22},137,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This Phase 1\u002F2a trial is a randomized, placebo-controlled trial to evaluate the safety, tolerability and immunogenicity of two ascending doses (10\\^6 PFU and 10\\^7 PFU) of intranasal BLB-201 (a recombinant parainfluenza virus type 5) administered in infants (8-24 months of age) and children (18-59 months of age) who may or may not have had prior respiratory syncytial virus (RSV) infection.",[29],"Respiratory Syncytial Virus Infections",[31,32],"Human respiratory syncytial virus (RSV)","Lower respiratory tract infection (LRTI)","RECRUITING","2026-06-01",{"date":36,"type":37},"2026-06-03","ACTUAL",{"date":39,"type":37},"2023-03-09",{"date":41,"type":22},"2028-12-30",{"name":43,"class":44},"Blue Lake Biotechnology Inc.","INDUSTRY",15,""]