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NCT05997264 · ClinicalTrials.gov registry record · Phase 2
Anthrax AV7909 Boost Evaluation Study
A Phase 2 study of Anthrax, sponsored by Biomedical Advanced Research and Development Authority.
- Active
- Registry status
- Phase 2
- Development phase
- 220
- Enrollment target
- 7
- Study locations
NCT05997264: Active Phase 2 study of Anthrax, sponsored by Biomedical Advanced Research and Development Authority.
NCT05997264 is a Phase 2 study of Anthrax that is active but no longer recruiting, run by Biomedical Advanced Research and Development Authority. The registered enrollment target is 220 participants, below the 742-participant average among 6 other Anthrax trials with a reported enrollment target (70% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05997264, a Phase 2 study of Anthrax, is active but no longer recruiting, sponsored by Biomedical Advanced Research and Development Authority.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 220 participants
- Enrollment target
- 7
- Study locations
Study Summary
This randomized, phase 2, double-blinded, multicenter study is designed to assess the safety and immune response kinetics of CYFENDUS™ (henceforth AV7909) administered on 2 primary series vaccination schedules followed by 6- and 12-month boosters.
Conditions Studied
Interventions
- BIOLOGICAL AV7909 Full Dose (0.5 mL)
- BIOLOGICAL AV7909 Half Dose (0.25 mL)
- BIOLOGICAL Placebo: Sodium Chloride Injection, USP 0.9% (0.5 mL)
- BIOLOGICAL Placebo: Sodium Chloride Injection, USP 0.9% (0.25 mL)
Study Locations (7)
North Carolina
- Accellacare of Hickory - Hickory
- Accellacare of Salisbury - Salisbury
- Accellacare of Piedmont - Statesville
- Accellacare of Winston-Salem - Winston-Salem
Tennessee
- Accellacare Knoxville - Jefferson City
- Accellacare Knoxville - Knoxville
- Accellacare Knoxville - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2023-12-05 |
| Est. Completion | 2026-08 |
| Phase | Phase 2 |
What the registry record for NCT05997264 still lists
NCT05997264 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 742-participant average among 6 other Anthrax trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Anthrax appearing as the primary indexed condition, and to 4 interventions - of which AV7909 Full Dose (0.5 mL) is the first listed.
NCT05997264 lists 7 locations in 2 states (North Carolina, Tennessee).
Frequently Asked Questions
What is clinical trial NCT05997264 about?
NCT05997264 is a clinical study titled "Anthrax AV7909 Boost Evaluation Study". This randomized, phase 2, double-blinded, multicenter study is designed to assess the safety and immune response kinetics of CYFENDUS™ (henceforth AV7909) administered on 2 primary series vaccination schedules followed by 6- and 12-month boosters.
What is the current status of trial NCT05997264?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 220 participants. The study started on 2023-12-05. Estimated completion is 2026-08.
What conditions does trial NCT05997264 study?
This clinical trial studies the following conditions: Anthrax.
What interventions are being tested in trial NCT05997264?
The interventions under investigation include: AV7909 Full Dose (0.5 mL) (BIOLOGICAL), AV7909 Half Dose (0.25 mL) (BIOLOGICAL), Placebo: Sodium Chloride Injection, USP 0.9% (0.5 mL) (BIOLOGICAL), Placebo: Sodium Chloride Injection, USP 0.9% (0.25 mL) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05997264?
This trial is sponsored by Biomedical Advanced Research and Development Authority, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05997264 being conducted?
This trial has 7 study locations across North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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