Actively Recruiting
A Phase 12a Trial of the Safety, Tolerability and Immunogenicity of PIV5-vectored RSV Vaccine BLB-201 in RSV Seronegative and Seropositive Infants and Children
Led by Blue Lake Biotechnology Inc. · Updated on 2026-06-03
137
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and immune response of an intranasal vaccine called BLB-201, which is designed to protect against respiratory syncytial virus RSV infection. This Phase 12a randomized, placebo-controlled trial includes infants aged 8 to 24 months and children aged 18 to 59 months, some of whom may have had prior RSV infection. The study aims to understand how different doses affect these young participants. Participants receive one or two doses of BLB-201 at either a low dose 106 PFU or a high dose 107 PFU given through the nose. Some children receive a placebo, which is a harmless saline solution, to compare effects. The doses are given on Day 1, and for some groups, a second dose is given on Day 57. The study includes groups based on age and prior RSV exposure to assess responses across different participant types. Throughout the trial, participants are closely monitored for any side effects from Day 1 to Day 29, including both expected and unexpected events. The study team also evaluates how well the vaccine triggers the immune system. Caregivers provide consent and ensure their child attends all scheduled visits. The entire study runs until late 2028, allowing researchers to gather thorough safety and immune response data over time.
CONDITIONS
Brief Title
A Study of BLB-201 RSV Vaccine in Infants and Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 18 to less than 60 months who are healthy and have RSV antibodies (sero+), with caregiver consent
- Children aged 8 to less than 25 months who are healthy and may be RSV antibody positive or negative, with caregiver consent
- Good overall health based on medical history and physical exam
- Routine immunizations up to date as per age recommendations
- Growing normally with height and weight above specified percentiles
- Available for the entire duration of the trial
You will not qualify if you...
- Younger than 8 months or older than 60 months at vaccination
- Born premature (less than 34 weeks if 1 year or older, less than 37 weeks if under 1 year)
- Maternal history of HIV or substance abuse
- Chronic diseases that are severe, unstable, or immune compromising
- Significant heart, lung, liver, or kidney abnormalities
- Recent or severe infections requiring hospitalization
- Immunosuppressive therapy or known immune disorders
- Major congenital malformations or developmental disorders
- History of wheezing episodes, bronchodilator use, or severe respiratory infections
- Previous RSV vaccine or antibody treatments within 6 months
- History of serious vaccine reactions or allergies to study vaccine components
- Household contact with infants under 6 months, pregnant women, immunocompromised individuals, or persons with recent severe respiratory illness
- Recent or planned receipt of certain vaccines or medications around the study period
- History of bleeding disorders
- Inadequate blood access for testing
- Positive test for RSV, influenza, or COVID-19 within 3 months prior to enrollment
- Any temporary illness such as fever, upper respiratory symptoms, or recent contact with someone with viral respiratory illness at enrollment
Research Team
H
Henry Radziewicz, MD PhD
N
Nubia Kaba
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