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NCT05397119 · ClinicalTrials.gov registry record · Phase 1
A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Pandemic Flu Vaccine in Healthy Adults
A Phase 1 study of Influenza, Pandemic, sponsored by BlueWillow Biologics.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05397119 is a Phase 1 study of Influenza, Pandemic that has completed, run by BlueWillow Biologics. The registered enrollment target is 40 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05397119, a Phase 1 study of Influenza, Pandemic, has completed, sponsored by BlueWillow Biologics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this clinical trial is to evaluate the safety and immunogenicity of BW-1014. BW-1014 is a nanoemulsion (NE) adjuvanted recombinant Hemagglutinin 5 (rH5) that would protect against pandemic flu. The study will be conducted in 40 healthy adults volunteers, age 18 - 45, in one center in the United States. The study will compare 3 different dose levels of rH5 (25µg, 50µg and 100µg rH5 in 20% NE adjuvant using a pipette dropper with rH5 control (100µg without NE adjuvant) and placebo control (saline). The investigational product will be administered in 2 doses intranasally (IN). This will be followed 6 months later with a licensed H5N1 IIV IM vaccine. In addition to safety outcome, homologous and heterologous immunological outcomes will be tested in nasal wash, serum, and blood cells.
Conditions Studied
Interventions
- BIOLOGICAL BW-1014: 25 µg rH5 in 20% NE - pipette - IN
- BIOLOGICAL BW-1014: 50 µg rH5 in 20% NE - pipette - IN
- BIOLOGICAL BW-1014: 100 µg rH5 in 20% NE - pipette - IN
- BIOLOGICAL rH5 (100 µg) control - pipette - IN
- BIOLOGICAL Saline (Placebo) - pipette - IN
Study Locations (1)
Maryland
- Center for Vaccine Development and Global Health, University of Maryland School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-07-07 |
| Est. Completion | 2023-10-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05397119
The ClinicalTrials.gov registry entry for NCT05397119 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BlueWillow Biologics, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Influenza, Pandemic appearing as the primary indexed condition, and to 5 interventions - of which BW-1014: 25 µg rH5 in 20% NE - pipette - IN is the first listed.
NCT05397119 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05397119 about?
NCT05397119 is a clinical study titled "A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Pandemic Flu Vaccine in Healthy Adults". The purpose of this clinical trial is to evaluate the safety and immunogenicity of BW-1014. BW-1014 is a nanoemulsion (NE) adjuvanted recombinant Hemagglutinin 5 (rH5) that would protect against pandemic flu. The study will be conducted in 40 healthy adults volunteers, age 18 - 45, in one center i...
What is the current status of trial NCT05397119?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2022-07-07. Estimated completion is 2023-10-12.
What conditions does trial NCT05397119 study?
This clinical trial studies the following conditions: Influenza, Pandemic.
What interventions are being tested in trial NCT05397119?
The interventions under investigation include: BW-1014: 25 µg rH5 in 20% NE - pipette - IN (BIOLOGICAL), BW-1014: 50 µg rH5 in 20% NE - pipette - IN (BIOLOGICAL), BW-1014: 100 µg rH5 in 20% NE - pipette - IN (BIOLOGICAL), rH5 (100 µg) control - pipette - IN (BIOLOGICAL), Saline (Placebo) - pipette - IN (BIOLOGICAL).
Who is sponsoring clinical trial NCT05397119?
This trial is sponsored by BlueWillow Biologics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05397119 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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