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

NCT05281263 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-12-21

No results posted yet for this study

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.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

CPI-RSV-F Vaccine (BLB-201)

see arm/group description

Sponsors & Collaborators

  • Blue Lake Biotechnology Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Spearman, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2022-12-05
Completion
2023-05-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05281263 on ClinicalTrials.gov