NCT05655182 · Blue Lake Biotechnology Inc.
A Study of BLB-201 RSV Vaccine in Infants and Children
What this study is about
This Phase 1/2a trial is a randomly assigned, compared against an inactive treatment 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.
View original scientific description
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.
Interventions
BIOLOGICAL
PIV5-vectored RSV Vaccine (BLB-201) Low Dose
BLB201 10\^6 PFU
BIOLOGICAL
PIV5-vectored RSV Vaccine (BLB-201) High Dose
BLB201 10\^7 PFU
DRUG
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).
Primary outcome measures
Solicited Adverse Events
Time frame: Day 1-15
Frequencies and grades of solicited local and systemic AEs during a 14-day period after dosing.
Unsolicited Adverse Events
Time frame: Day 1-29
Frequencies and grades of unsolicited AEs during a 28-day period after dosing.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- for sero+ children 18 to 59 months of age enrolled in Groups 1 and 2: Healthy 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. 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
Where
- La Mesa, California
- Modesto, California
- Aurora, Colorado
- Meridian, Idaho
- Rexburg, Idaho
- Newton, Kansas
- Lafayette, Louisiana
- Allen Park, Michigan
- Grand Island, Nebraska
- Lincoln, Nebraska
- Beachwood, Ohio
- Cincinnati, Ohio
And 3 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations