RECRUITING

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

Talk to us

Conditions

Respiratory Syncytial Virus InfectionsHuman respiratory syncytial virus (RSV)Lower respiratory tract infection (LRTI)

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-03-09
Study Completion:2024-12-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05655182

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.

Ages Eligible for Study:6 Months to 5 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Marinka Tellier
CONTACT
7062017798
mtellier@cyanvacllc.com
Henry Radziewicz, MD PhD
CONTACT
HRadziewicz@bluelakebiotechnology.com

Principal Investigator

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

Study Locations (Sites)

Paradigm Clinical Research
La Mesa, California, 91942
United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274
United States
Velocity Clinical Research, Boise
Meridian, Idaho, 83642
United States
Clinical Research Prime
Rexburg, Idaho, 83440
United States
AMR Newton
Newton, Kansas, 67114
United States
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, 70508
United States
Great Lakes Research Institute
Southfield, Michigan, 48075
United States
Velocity Clinical Research, Hastings
Hastings, Nebraska, 68901
United States
Velocity Clinical Research, Cleveland
Beachwood, Ohio, 44122
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Velocity Clinical Research, Austin
Cedar Park, Texas, 78613
United States
Baylor College of Medicine
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Blue Lake Biotechnology Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-09
Study Completion Date2024-12-23

Study Record Updates

Study Start Date2023-03-09
Study Completion Date2024-12-23

Terms related to this study

Keywords Provided by Researchers

  • Human respiratory syncytial virus (RSV)
  • Lower respiratory tract infection (LRTI)

Additional Relevant MeSH Terms

  • Respiratory Syncytial Virus Infections