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

NCT05655182 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2025-12-15

No results posted yet for this study

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.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

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).

Sponsors & Collaborators

  • Blue Lake Biotechnology Inc.

    lead INDUSTRY

Principal Investigators

  • Hong Jin, MD · Blue Lake Biotechnology Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-09
Primary Completion
2028-07-30
Completion
2028-07-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT05655182 on ClinicalTrials.gov