๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-27

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

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Blue Lake Biotechnology Inc.

๐Ÿฉบ 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

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ 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

๐Ÿ“ž 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.

๐Ÿ’ฐ 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—