NCT05281263

Phase 1 Study of BLB-201 Vaccine in Healthy Young and Older Adults

A Phase 1 Trial of the Safety, Tolerability, and Immunogenicity of BLB-201 Vaccine in Healthy Young Adults and Older Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Blue Lake Biotechnology Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This Phase 1 trial is an open-label trial to evaluate the safety, tolerability and immunogenicity of a single dose (10\^7.5 PFU) of intranasal BLB-201 (a recombinant parainfluenza virus type 5) administered as a single dose in 15 healthy young adults ages 18-59 years, and 15 older adults ages 60-75 years.

Detailed description

This will be an open-label, age-escalation phase 1 trial of the PIV5 virus-vectored BLB-201 vaccine in healthy adults (males and nonpregnant females) 18 to 59 years of age (Group 1), and 60 to 75 years of age (Group 2). The trial is designed to assess the safety, tolerability, and immunogenicity of a single dose of intranasal BLB-201 at 10\^7.5 plaque- forming units (PFU) in both Group 1 and Group 2. The first 4 subjects in each group will be enrolled as sentinels and vaccination will proceed in a staged fashion.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	CPI-RSV-F Vaccine (BLB-201)	see arm/group description

Timeline

• Start date: 2022-07-20
• Primary completion: 2022-12-05
• Completion: 2023-05-03
• First posted: 2022-03-16
• Last updated: 2023-12-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study