NCT05655182

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 137 (estimated)
• Sponsor: Blue Lake Biotechnology Inc. · Industry
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Accepted

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.

Detailed description

This trial is designed to evaluate the safety, tolerability and immunogenicity of BLB-201 vaccine 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. One (Day 1) or two doses (Day 1 and Day 57) of low (10\^6 PFU) and high dosage (10\^7 PFU) of BLB-201 will be evaluated.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	PIV5-vectored RSV Vaccine (BLB-201) Low Dose	BLB201 10\^6 PFU
BIOLOGICAL	PIV5-vectored RSV Vaccine (BLB-201) High Dose	BLB201 10\^7 PFU
DRUG	Placebo	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).

Timeline

• Start date: 2023-03-09
• Primary completion: 2028-07-30
• Completion: 2028-07-30
• First posted: 2022-12-19
• Last updated: 2025-12-15

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study