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NCT05655182 · ClinicalTrials.gov registry record · Phase 1
A Study of BLB-201 RSV Vaccine in Infants and Children
A Phase 1 study of Respiratory Syncytial Virus Infections, sponsored by Blue Lake Biotechnology.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 137
- Enrollment target
- 11
- Study locations
NCT05655182: Recruiting Phase 1 study of Respiratory Syncytial Virus Infections, sponsored by Blue Lake Biotechnology.
NCT05655182 is a Phase 1 study of Respiratory Syncytial Virus Infections that is actively recruiting participants, run by Blue Lake Biotechnology. The registered enrollment target is 137 participants, below the 1,085-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (87% lower). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05655182, a Phase 1 study of Respiratory Syncytial Virus Infections, is actively recruiting participants, sponsored by Blue Lake Biotechnology.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 137 participants
- Enrollment target
- 11
- Study locations
Study Summary
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.
Primary Outcome
Frequencies and grades of solicited local and systemic AEs during a 14-day period after dosing.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL PIV5-vectored RSV Vaccine (BLB-201) Low Dose
- BIOLOGICAL PIV5-vectored RSV Vaccine (BLB-201) High Dose
Study Locations (11)
California
- Paradigm Clinical Research - La Mesa
- Paradigm Clinical Research - Modesto - Modesto
Idaho
- Velocity Clinical Research, Boise - Meridian
- Clinical Research Prime - Rexburg
Ohio
- Velocity Clinical Research, Cleveland - Beachwood
- Cincinnati Children's Hospital Medical Center - Cincinnati
Texas
- Velocity Clinical Research, Austin - Cedar Park
- Baylor College of Medicine - Houston
Kansas
- AMR Newton - Newton
Louisiana
- Velocity Clinical Research - Lafayette - Lafayette
Nebraska
- Velocity Clinical Research, Grand Island - Grand Island
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2023-03-09 |
| Est. Completion | 2028-07-30 |
| Phase | Phase 1 |
What NCT05655182 shows while recruiting
NCT05655182 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, below the 1,085-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Respiratory Syncytial Virus Infections appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05655182 lists 11 locations in 7 states (California, Idaho, Ohio).
Frequently Asked Questions
What is clinical trial NCT05655182 about?
NCT05655182 is a clinical study titled "A Study of BLB-201 RSV Vaccine in Infants and Children". 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 m...
What is the current status of trial NCT05655182?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 137 participants. The study started on 2023-03-09. Estimated completion is 2028-07-30.
What conditions does trial NCT05655182 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus Infections.
What interventions are being tested in trial NCT05655182?
The interventions under investigation include: Placebo (DRUG), PIV5-vectored RSV Vaccine (BLB-201) Low Dose (BIOLOGICAL), PIV5-vectored RSV Vaccine (BLB-201) High Dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT05655182?
This trial is sponsored by Blue Lake Biotechnology, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05655182 being conducted?
This trial has 11 study locations across California, Idaho, Kansas, Louisiana, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Respiratory Syncytial Virus Infections
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Where NCT05655182's enrollment target sits among peer trials
137 16th of 21 higher than 6 of 21 other Respiratory Syncytial Virus Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Syncytial Virus Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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