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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: Completed Phase 1 study, sponsored by BlueWillow Biologics.
NCT04148118 is a Phase 1 study that has completed, run by BlueWillow Biologics. The registered enrollment target is 84 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This will be conducted throughout the 2 hours in-clinic observation following each immunization, during the follow up Safety Phone Call conducted 1-3 days post immunization, during the review of the Symptom Diary Reminder Card that will be distributed to participants following immunization and during the 7 to 10 day visit following each immunization.
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 |
What the finished NCT04148118 record still lists
NCT04148118 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 5 interventions - of which BW-1010: 50 µg - sprayer - IN is the first listed.
NCT04148118 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04148118's enrollment target sits among peer trials
84 659th of 2000 higher than 1,336 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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