A Study of BLB-201 RSV Vaccine in Infants and Children (NCT05655182)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Paradigm Clinical Research โ La Mesa, California
Age range: 6 Months to 5 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (16 Sites)
- Paradigm Clinical Research โ La Mesa, California
- Paradigm Clinical Research - Modesto โ Modesto, California
- University of California, San Diego โ San Diego, California
- Paradigm Clinical Research Centers, LLC - Colorado, 1550 South Potomac Street, Suite 340 โ Aurora, Colorado
- Velocity Clinical Research, Boise โ Meridian, Idaho
- Clinical Research Prime โ Rexburg, Idaho
- AMR Newton โ Newton, Kansas
- Velocity Clinical Research - Lafayette โ Lafayette, Louisiana
- Michigan Institute of Research โ Allen Park, Michigan
- Velocity Clinical Research, Grand Island โ Grand Island, Nebraska
- Be Well Clinical Studies โ Lincoln, Nebraska
- Velocity Clinical Research, Cleveland โ Beachwood, Ohio
- Cincinnati Children's Hospital Medical Center โ Cincinnati, Ohio
- Tribe Clinical Research, LLC Parkside Pediatrics โ Greenville, South Carolina
- Velocity Clinical Research, Austin โ Cedar Park, Texas
- Baylor College of Medicine โ Houston, Texas
๐ Contact the Study Coordinator
Phone: (585) 313-0027
Email: HRadziewicz@bluelakebiotechnology.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.