Actively Recruiting
A Phase 1/2a 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 1/2a 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 (10^6 PFU) or a high dose (10^7 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 weeks
Participants receive one or two doses of the BLB-201 RSV vaccine or placebo by intranasal route.
1 or 2 dosing visits on Day 1 and Day 57
Duration - Up to 29 days after last dose
Participants are monitored for safety and adverse events after vaccination.
Several visits for safety monitoring during days 1 to 29 after vaccination
Trial Site Locations
Total: 15 locations
1
Paradigm Clinical Research
La Mesa, California, United States, 91942
Actively Recruiting
2
Paradigm Clinical Research - Modesto
Modesto, California, United States, 95355
Actively Recruiting
3
Paradigm Clinical Research Centers, LLC - Colorado, 1550 South Potomac Street, Suite 340
Aurora, Colorado, United States, 80012
Actively Recruiting
4
Velocity Clinical Research, Boise
Meridian, Idaho, United States, 83642
Actively Recruiting
5
Clinical Research Prime
Rexburg, Idaho, United States, 83440
Actively Recruiting
6
AMR Newton
Newton, Kansas, United States, 67114
Actively Recruiting
7
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, United States, 70508
Actively Recruiting
8
Michigan Institute of Research
Allen Park, Michigan, United States, 48101
Actively Recruiting
9
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States, 68803
Actively Recruiting
10
Be Well Clinical Studies
Lincoln, Nebraska, United States, 68516
Actively Recruiting
11
Velocity Clinical Research, Cleveland
Beachwood, Ohio, United States, 44122
Actively Recruiting
12
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
13
Tribe Clinical Research, LLC Parkside Pediatrics
Greenville, South Carolina, United States, 29680
Actively Recruiting
14
Velocity Clinical Research, Austin
Cedar Park, Texas, United States, 78613
Actively Recruiting
15
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Henry Radziewicz, MD PhD
N
Nubia Kaba
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
10
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