Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
137 participants
INTERVENTIONAL
2023-03-09
2028-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
NCT04491877
A Study on the Immunogenicity and Safety of 3 Different Dose Concentrations of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers
NCT06705140
A Phase 1/2A Study to Evaluate the Safety, Immunogenicity, and Shedding of MEDI-560 in Infants 1 to < 12 Months of Age
NCT00508651
Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants
NCT05584202
Study of Palivizumab in Children With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease
NCT06851806
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 2, infants (age 18-59 months), RSV+, Placebo
4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
Placebo
The placebo used for the trial will be the same as the diluent (0.9% sterile saline) used for the low dose group (10\^6 PFU).
Group 3, children (age 8-24 months), RSV+ or RSV-, BLB201 10^6 PFU
16 participants will be administered BLB201 10\^6 PFU by intranasal route on Day 1
PIV5-vectored RSV Vaccine (BLB-201) Low Dose
BLB201 10\^6 PFU
Group 3, children (age 8-24 months), RSV+ or RSV-, Placebo
8 participants will be administered placebo by intranasal route on Day 1
Placebo
The placebo used for the trial will be the same as the diluent (0.9% sterile saline) used for the low dose group (10\^6 PFU).
Group 4, children (age 6-24 months), RSV+ or RSV-, BLB201 10^7 PFU
32 participants will be administered BLB201 10\^7 PFU by intranasal route on Day 1
PIV5-vectored RSV Vaccine (BLB-201) High Dose
BLB201 10\^7 PFU
Group 4, children (age 8-24 months), RSV+ or RSV-, Placebo
16 participants will be administered placebo by intranasal route on Day 1
Placebo
The placebo used for the trial will be the same as the diluent (0.9% sterile saline) used for the low dose group (10\^6 PFU).
Group 6, children (age 8-24 months), RSV+ or RSV-, BLB201 10^7 PFU
30 participants will be administered BLB201 10\^7 PFU by intranasal route on Day 1 and Day 57
PIV5-vectored RSV Vaccine (BLB-201) High Dose
BLB201 10\^7 PFU
Group 6, children (age 8-24 months), RSV+ or RSV-, Placebo
15 participants will be administered Placebo by intranasal route on Day 1 and Day 57
Placebo
The placebo used for the trial will be the same as the diluent (0.9% sterile saline) used for the low dose group (10\^6 PFU).
Group 1, infants (age 18-59 months), RSV+, Placebo
4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
Placebo
The placebo used for the trial will be the same as the diluent (0.9% sterile saline) used for the low dose group (10\^6 PFU).
Group 2, infants (age 18-59 months), RSV+, BLB201 10^7 PFU
6 RSV seropositive participants will be administered 10\^7 PFU BLB-201 by intranasal route on Day 1
PIV5-vectored RSV Vaccine (BLB-201) High Dose
BLB201 10\^7 PFU
Group 1, infants (age 18-59 months), RSV+, BLB201 10^6 PFU
6 RSV seropositive participants will be administered 10\^6 PFU BLB-201 by intranasal route on Day 1
PIV5-vectored RSV Vaccine (BLB-201) Low Dose
BLB201 10\^6 PFU
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PIV5-vectored RSV Vaccine (BLB-201) Low Dose
BLB201 10\^6 PFU
PIV5-vectored RSV Vaccine (BLB-201) High Dose
BLB201 10\^7 PFU
Placebo
The placebo used for the trial will be the same as the diluent (0.9% sterile saline) used for the low dose group (10\^6 PFU).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Determined 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.
Sero+ for RSV as defined by serum RSV antibody titer assay
Participant is expected to be available for the duration of the trial.
The 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.
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.
Healthy 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.
Determined 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.
Sero- OR sero+ for RSV antibody, defined by serum RSV antibody titer assay not more than 30 days prior to vaccination.
Participant is expected to be available for the duration of the trial.
The 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.
Growing normally for age as demonstrated on a World Health Organization (WHO) growth chart, AND
If \<1 year of age: has a current height and weight above the 5th percentile for age.
If ≥1 year of age: has a current height and weight above the 3rd percentile for age.
Exclusion Criteria
Born at less than 34 weeks gestation for subjects ≥ 1 year of age at enrollment
Born at less than 37 weeks gestation, and at the date of inoculation less than 1 year of age.
Maternal history of a positive HIV test before or during pregnancy.
Maternal history of illicit drug abuse or alcohol abuse.
Evidence of chronic disease except for chronic diseases that are mild, stable and not immune compromising or require recent change (\< 60 days) in management (e.g., mild stable eczema, mild allergic rhinitis)
Clinically 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.
Acute 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.
History of severe infection (e.g., requiring hospitalization).
Known or suspected impairment of immunological functions, bone marrow/solid organ transplant recipients.
Receiving immunosuppressive therapy including systemic corticosteroids.
Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities.
Suspected or documented developmental disorder, delay, or other developmental problem.
Cardiac abnormality requiring treatment. Participants with clinically insignificant cardiac abnormalities (e.g., clinically insignificant patent foramen ovale) requiring no treatment may be enrolled.
Lung disease or reactive airway disease.
History of wheezing episode/s or receipt of bronchodilator therapy
Previous receipt of supplemental oxygen therapy in a home setting.
History of severe RSV infection or severe respiratory virus infection (e.g., requiring hospitalization).
Previous immunization with an investigational RSV vaccine.
Previous or planned administration of any anti-RSV antibody product within 6 months of receipt of study vaccine.
Previous receipt of immunoglobulin or any other antibody products within the past 6 months.
Previous receipt of any blood products within the past 6 months.
Previous anaphylactic reaction.
Previous serious vaccine-associated adverse reaction or one that was Grade 3 or above.
Known hypersensitivity to any study vaccine product component.
Household 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):
Member 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.
Pregnant woman.
Persons with hospitalization for asthma or other chronic respiratory disease in the past 5 years.
Member 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:
A person who is HIV-infected.
A person who has cancer and has received chemotherapy within the 12 months prior to enrollment.
A person with a solid organ or bone marrow transplant.
A person currently receiving immunosuppressive agents.
Attends a daycare facility that does not separate children by age and contains an infant
\<6 months of age at the date of inoculation through the 28th day after inoculation.
Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
History of postinfectious or postvaccine neurological sequelae.
Autoimmune, inflammatory, vascular, or rheumatic disease.
Household contact of another child enrolled into the trial.
Inadequate venous access for repeated phlebotomy.
Subject's LAR/s 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.
Subjects testing positive for infection with RSV, Influenza, or SARS-CoV-2 in the 3 months prior to enrollment.
Planned receipt of any of the following prior to planned trial vaccine receipt (Day 1 and Day 57 for group receiving 2 doses of vaccine):
Inactivated influenza vaccine within 14 days prior, or
Any other inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days prior, or
Any live vaccine, other than rotavirus vaccine, within the 28 days prior, or
Another investigational vaccine or investigational drug within 28 days prior.
Salicylate (aspirin) or salicylate-containing products within 28 days prior.
Planned receipt of any of the following after planned trial vaccine receipt (Day 1 and Day 57 for groups receiving 2 doses of vaccine):
Inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days after, or
Any live vaccine other than rotavirus in the 28 days after, or
Another investigational vaccine or investigational drug in the 56 days after.
Planned 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):
Systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or systemic or nasal steroid therapy for acute illness.
Any other intranasal medications, or
Other 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.
History of bleeding disorder or significant problem with bleeding
American Indian or Alaska Native Infants/Children (high risk for severe RSV infection) AND eligible to receive nirsevimab
The 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.
Any of the following events at the time of enrollment:
Fever (temperature of ≥100.4°F per site standard based on age; e.g., oral for older children, rectal for infants, axillary screening), or
Upper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis) or
Nasal congestion significant enough to interfere with successful vaccination.
Otitis media.
Contact with a person diagnosed with RSV, Influenza, coronavirus disease-2 (COVID- 19) or other viral respiratory illnesses within the preceding 10 days.
6 Months
5 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Blue Lake Biotechnology Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hong Jin, MD
Role: PRINCIPAL_INVESTIGATOR
Blue Lake Biotechnology Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Paradigm Clinical Research
La Mesa, California, United States
Paradigm Clinical Research - Modesto
Modesto, California, United States
Velocity Clinical Research, Boise
Meridian, Idaho, United States
Clinical Research Prime
Rexburg, Idaho, United States
AMR Newton
Newton, Kansas, United States
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States
Velocity Clinical Research, Cleveland
Beachwood, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Velocity Clinical Research, Austin
Cedar Park, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BLB-201-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.