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NCT05281263 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of BLB-201 Vaccine in Healthy Young and Older Adults
A Phase 1 study, sponsored by Blue Lake Biotechnology.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT05281263: Completed Phase 1 study, sponsored by Blue Lake Biotechnology.
NCT05281263 is a Phase 1 study that has completed, run by Blue Lake Biotechnology. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05281263, a Phase 1 study, has completed, sponsored by Blue Lake Biotechnology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
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.
Primary Outcome
Frequencies and grades of solicited local and systemic AEs during a 7-day period after dosing.
Interventions
- BIOLOGICAL CPI-RSV-F Vaccine (BLB-201)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-07-20 |
| Est. Completion | 2023-05-03 |
| Phase | Phase 1 |
What the finished NCT05281263 record still lists
NCT05281263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which CPI-RSV-F Vaccine (BLB-201) is the first listed.
NCT05281263 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05281263 about?
NCT05281263 is a clinical study titled "Phase 1 Study of BLB-201 Vaccine in Healthy Young and Older Adults". 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 ...
What is the current status of trial NCT05281263?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2022-07-20. Estimated completion is 2023-05-03.
What interventions are being tested in trial NCT05281263?
The interventions under investigation include: CPI-RSV-F Vaccine (BLB-201) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05281263?
This trial is sponsored by Blue Lake Biotechnology, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05281263's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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