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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 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.

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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.

Conditions Studied

Respiratory Syncytial Virus Infections

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

FieldValue
Enrollment Target 137 participants
Start Date 2023-03-09
Est. Completion 2028-07-30
Phase Phase 1

Sponsor

Blue Lake Biotechnology

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05655182

The ClinicalTrials.gov registry entry for NCT05655182 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 137 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,085-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (87% lower). The listed sponsor is Blue Lake Biotechnology, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 11 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.