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

Phase 1

Recruiting

• Conditions: Respiratory Syncytial Virus Infections
• Interventions: Biological: PIV5-vectored RSV Vaccine (BLB-201) Low Dose; Drug: Placebo; Biological: PIV5-vectored RSV Vaccine (BLB-201) High Dose

• Registration Number: NCT05655182
• Lead Sponsor: Blue Lake Biotechnology Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2022-12-08
• Study First Posted: 2022-12-19
• Study Start: 2023-03-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Primary Completion: 2024-09-14
• Study Completion: 2024-12-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 1, infants (age 18-59 months), RSV+, BLB201 10^6 PFU	PIV5-vectored RSV Vaccine (BLB-201) Low Dose	6 RSV seropositive participants will be administered 10\^6 PFU BLB-201 by intranasal route on Day 1
Group 1, infants (age 18-59 months), RSV+, Placebo	Placebo	4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
Group 2, infants (age 18-59 months), RSV+, BLB201 10^7 PFU	PIV5-vectored RSV Vaccine (BLB-201) High Dose	6 RSV seropositive participants will be administered 10\^7 PFU BLB-201 by intranasal route on Day 1
Group 2, infants (age 18-59 months), RSV+, Placebo	Placebo	4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
Group 3, children (age 8-24 months), RSV+ or RSV-, BLB201 10^6 PFU	PIV5-vectored RSV Vaccine (BLB-201) Low Dose	16 participants will be administered BLB201 10\^6 PFU by intranasal route on Day 1
Group 3, children (age 8-24 months), RSV+ or RSV-, Placebo	Placebo	8 participants will be administered placebo by intranasal route on Day 1
Group 4, children (age 6-24 months), RSV+ or RSV-, BLB201 10^7 PFU	PIV5-vectored RSV Vaccine (BLB-201) High Dose	32 participants will be administered BLB201 10\^7 PFU by intranasal route on Day 1
Group 4, children (age 8-24 months), RSV+ or RSV-, Placebo	Placebo	16 participants will be administered placebo by intranasal route on Day 1
Group 6, children (age 8-24 months), RSV+ or RSV-, BLB201 10^7 PFU	PIV5-vectored RSV Vaccine (BLB-201) High Dose	30 participants will be administered BLB201 10\^7 PFU by intranasal route on Day 1 and Day 57
Group 6, children (age 8-24 months), RSV+ or RSV-, Placebo	Placebo	15 participants will be administered Placebo by intranasal route on Day 1 and Day 57

Primary Outcome Measures

Name	Time	Method
Solicited Adverse Events	Day 1-15	Frequencies and grades of solicited local and systemic AEs during a 14-day period after dosing.
Unsolicited Adverse Events	Day 1-29	Frequencies and grades of unsolicited AEs during a 28-day period after dosing.

Trial Locations

Locations (12)

Peninsula Research Associates; 🇺🇸 Rolling Hills Estates, California, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Velocity Clinical Research, Hastings; 🇺🇸 Hastings, Nebraska, United States

Great Lakes Research Institute; 🇺🇸 Southfield, Michigan, United States

Velocity Clinical Research, Austin; 🇺🇸 Cedar Park, Texas, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Velocity Clinical Research, Cleveland; 🇺🇸 Beachwood, Ohio, United States

Paradigm Clinical Research; 🇺🇸 La Mesa, California, United States

Velocity Clinical Research, Boise; 🇺🇸 Meridian, Idaho, United States

Clinical Research Prime; 🇺🇸 Rexburg, Idaho, United States

AMR Newton; 🇺🇸 Newton, Kansas, United States

Velocity Clinical Research - Lafayette; 🇺🇸 Lafayette, Louisiana, United States