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

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.

Conditions

Respiratory Syncytial Virus Infections

Study Overview

Study Details

Study overview

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.

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

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

Condition
Respiratory Syncytial Virus Infections
Intervention / Treatment

-

Contacts and Locations

La Mesa

Paradigm Clinical Research, La Mesa, California, United States, 91942

Rolling Hills Estates

Peninsula Research Associates, Rolling Hills Estates, California, United States, 90274

Meridian

Velocity Clinical Research, Boise, Meridian, Idaho, United States, 83642

Rexburg

Clinical Research Prime, Rexburg, Idaho, United States, 83440

Newton

AMR Newton, Newton, Kansas, United States, 67114

Lafayette

Velocity Clinical Research - Lafayette, Lafayette, Louisiana, United States, 70508

Southfield

Great Lakes Research Institute, Southfield, Michigan, United States, 48075

Hastings

Velocity Clinical Research, Hastings, Hastings, Nebraska, United States, 68901

Beachwood

Velocity Clinical Research, Cleveland, Beachwood, Ohio, United States, 44122

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    6 Months to 5 Years

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    Yes

    Collaborators and Investigators

    Blue Lake Biotechnology Inc.,

    Paul Spearman, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

    Study Record Dates

    2024-12-23