Actively Recruiting
A Study of BLB-201 RSV Vaccine in Infants and Children
Led by Blue Lake Biotechnology Inc. · Updated on 2025-12-15
137
Participants Needed
11
Research Sites
281 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase 1/2a 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.
CONDITIONS
Official 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 whose parent or guardian understands and consents to the trial
- Children aged 8 to less than 25 months who are healthy and whose parent or guardian understands and consents to the trial
- Good general health based on medical history, physical exam, and investigator judgment
- RSV seropositive children aged 18 to 59 months or RSV seropositive or seronegative children aged 8 to 24 months as confirmed by serum antibody test
- Participants expected to be available for the duration of the trial
- Receipt of routine immunizations appropriate for age according to current recommended schedules
- Normal growth for age according to World Health Organization growth charts, with height and weight above the 3rd percentile for older children and above the 5th percentile if under 1 year old
You will not qualify if you...
- Children younger than 8 months or older than 60 months at planned vaccination
- Born before 34 weeks gestation if aged 1 year or older, or born before 37 weeks gestation if less than 1 year old
- Maternal history of HIV infection or substance abuse
- Chronic diseases that are not mild, stable, or require recent management changes
- Significant heart, lung, liver, or kidney problems or abnormal oxygen levels
- Acute or chronic medical conditions or lab abnormalities increasing study risk
- History of severe infections requiring hospitalization
- Immune system impairments or use of immunosuppressive therapy
- Major congenital malformations or developmental disorders
- History of wheezing, bronchodilator use, oxygen therapy, or severe RSV infection
- Prior receipt of investigational RSV vaccine or anti-RSV antibodies within 6 months
- Previous serious vaccine reactions or allergies to study vaccine components
- Household contact with infants under 6 months, pregnant women, immunocompromised individuals, or persons hospitalized for chronic respiratory disease in recent years
- Attendance at daycare without age separation containing infants under 6 months
- Neurological, autoimmune, inflammatory, or rheumatic diseases
- Inadequate venous access for blood draws
- Positive test for RSV, Influenza, or COVID-19 in the past 3 months
- Planned receipt of certain vaccines or medications near study vaccination dates
- History of bleeding disorders
- Certain ethnic groups eligible for other preventive treatments
- Temporary exclusion for fever, respiratory symptoms, otitis media, or recent contact with persons with viral respiratory illnesses
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 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
Velocity Clinical Research, Boise
Meridian, Idaho, United States, 83642
Actively Recruiting
4
Clinical Research Prime
Rexburg, Idaho, United States, 83440
Actively Recruiting
5
AMR Newton
Newton, Kansas, United States, 67114
Actively Recruiting
6
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, United States, 70508
Actively Recruiting
7
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States, 68803
Actively Recruiting
8
Velocity Clinical Research, Cleveland
Beachwood, Ohio, United States, 44122
Actively Recruiting
9
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
10
Velocity Clinical Research, Austin
Cedar Park, Texas, United States, 78613
Actively Recruiting
11
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Henry Radziewicz, MD PhD
CONTACT
N
Nubia Kaba
CONTACT
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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