RecruitingPhase 1Phase 2NCT05655182

A Study of BLB-201 RSV Vaccine in Infants and Children

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

Sponsor

Blue Lake Biotechnology Inc.

Enrollment

137 participants

Start Date

Mar 9, 2023

Study Type

INTERVENTIONAL

Conditions

Respiratory Syncytial Virus Infections

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.

Eligibility

Min Age: 6 MonthsMax Age: 5 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called PIV5-vectored RSV Vaccine (BLB-201) High Dose, a biological treatment called PIV5-vectored RSV Vaccine (BLB-201) Low Dose, and others for people with respiratory syncytial virus infections. The study is currently recruiting participants at 16 locations. People eligible for this study include aged 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. to {"Phase 1","Phase 2"}.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALPIV5-vectored RSV Vaccine (BLB-201) Low Dose

BLB201 10\^6 PFU

BIOLOGICALPIV5-vectored RSV Vaccine (BLB-201) High Dose

BLB201 10\^7 PFU

DRUGPlacebo

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).

Locations(16)

Paradigm Clinical Research

La Mesa, California, United States

Paradigm Clinical Research - Modesto

Modesto, California, United States

University of California, San Diego

San Diego, California, United States

Paradigm Clinical Research Centers, LLC - Colorado, 1550 South Potomac Street, Suite 340

Aurora, Colorado, United States

Velocity Clinical Research, Boise

Meridian, Idaho, United States

Clinical Research Prime

Rexburg, Idaho, United States

AMR Newton

Newton, Kansas, United States

Velocity Clinical Research - Lafayette

Lafayette, Louisiana, United States

Michigan Institute of Research

Allen Park, Michigan, United States

Velocity Clinical Research, Grand Island

Grand Island, Nebraska, United States

Be Well Clinical Studies

Lincoln, Nebraska, United States

Velocity Clinical Research, Cleveland

Beachwood, Ohio, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Tribe Clinical Research, LLC Parkside Pediatrics

Greenville, South Carolina, United States

Velocity Clinical Research, Austin

Cedar Park, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05655182

Related Trials

A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease

NCT0721457180 locations

Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections

NCT063633701 location

A Study of Ziresovir (AK0529) in High-risk Adult With Respiratory Syncytial Virus (RSV) Infection.

NCT076585349 locations

Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokine Storm in Patients With Acute Respiratory Infection Caused by SARS-Cov-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV)

NCT066843793 locations

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

NCT0722010915 locations