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Virus Therapy

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

Phase 1
Waitlist Available
Led By Paul Spearman, MD
Research Sponsored by Blue Lake Biotechnology Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 15, and day 29
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a nasal vaccine called BLB-201 in healthy adults aged 18-59 and 60-75. The vaccine uses a modified virus to help the immune system learn to fight infections. The study aims to see if the vaccine is safe and effective in these age groups.

Eligible Conditions
  • Respiratory Syncytial Virus Infection
  • Respiratory Syncytial Virus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 15, and day 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 15, and day 29 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Solicited Adverse Events
Unsolicited Adverse Events
Secondary study objectives
Serious Adverse Events through trial completion
Serious adverse events, new-onset chronic medical conditions, and adverse events of special interest
Serum IgG titers to RSV protein

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2, older adult cohort (age 60-75)Experimental Treatment1 Intervention
BLB-201 administered as a single dose of 10\^7.5 PFU by intranasal route on Day 1
Group II: Group 1, young adult cohort (age 18-59)Experimental Treatment1 Intervention
BLB-201 administered as a single dose of 10\^7.5 PFU by intranasal route on Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CPI-RSV-F Vaccine (BLB-201)
2022
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Blue Lake Biotechnology Inc.Lead Sponsor
1 Previous Clinical Trials
137 Total Patients Enrolled
Paul Spearman, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
4 Previous Clinical Trials
532 Total Patients Enrolled
~9 spots leftby Dec 2025
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