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NCT04148118 · ClinicalTrials.gov registry record · Phase 1
A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Anthrax Vaccine in Healthy Adults
A Phase 1 study, sponsored by BlueWillow Biologics.
- Completed
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
NCT04148118 is a Phase 1 study that has completed, run by BlueWillow Biologics. The registered enrollment target is 84 participants.
The verdict
NCT04148118, a Phase 1 study, has completed, sponsored by BlueWillow Biologics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
Study Summary
The purpose of this clinical trial is to evaluate the safety and immunogenicity of BW-1010. BW-1010 is a nanoemulsion adjuvanted recombinant protein (rPA) that would protect against fatal outcome resulting from exposure to anthrax. The vaccine will be administered intranasally (IN) to healthy adults, age 18 - 49. The study will be conducted in 84 volunteers in one center in the United States. The study will compare 2 different dose levels of rPA (50µg and 100µg rPA), and 2 different administration methods (a sprayer and dropper) with a negative control (saline) and a positive control (the injectable BioThrax licensed vaccine). The vaccines and negative controls will be administered in 2 IN doses (4 weeks apart). The positive control will be 3 subcutaneous doses, 2 weeks apart. All volunteers will be observed for 1 year after the last dose. Immunological outcome studied will be from the serum, blood cells and nasal washes.
Interventions
- BIOLOGICAL BW-1010: 50 µg - sprayer - IN
- BIOLOGICAL BW-1010: 50 µg - pipette - IN
- BIOLOGICAL BW-1010: 100 µg - sprayer - IN
- BIOLOGICAL BW-1010: 100 µg - pipette - IN
- BIOLOGICAL Saline (Placebo) - sprayer - IN
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2020-01-08 |
| Est. Completion | 2021-09-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04148118
The ClinicalTrials.gov registry entry for NCT04148118 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 84 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 0 conditions, and to 5 interventions - of which BW-1010: 50 µg - sprayer - IN is the first listed.
NCT04148118 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04148118 about?
NCT04148118 is a clinical study titled "A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Anthrax Vaccine in Healthy Adults". The purpose of this clinical trial is to evaluate the safety and immunogenicity of BW-1010. BW-1010 is a nanoemulsion adjuvanted recombinant protein (rPA) that would protect against fatal outcome resulting from exposure to anthrax. The vaccine will be administered intranasally (IN) to healthy adul...
What is the current status of trial NCT04148118?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2020-01-08. Estimated completion is 2021-09-02.
What interventions are being tested in trial NCT04148118?
The interventions under investigation include: BW-1010: 50 µg - sprayer - IN (BIOLOGICAL), BW-1010: 50 µg - pipette - IN (BIOLOGICAL), BW-1010: 100 µg - sprayer - IN (BIOLOGICAL), BW-1010: 100 µg - pipette - IN (BIOLOGICAL), Saline (Placebo) - sprayer - IN (BIOLOGICAL).
Who is sponsoring clinical trial NCT04148118?
This trial is sponsored by BlueWillow Biologics, which has 2 total clinical trials registered on ClinicalTrials.gov.
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