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NCT01979406 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Ascending Dose Study to Assess the Safety and Immunogenicity of Adenovirus Anthrax Vector Candidate Vaccines
A Phase 1 study, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
NCT01979406: Completed Phase 1 study, sponsored by Emergent BioSolutions.
NCT01979406 is a Phase 1 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 120 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01979406, a Phase 1 study, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate 2 vaccine candidates against anthrax compared to the positive (vaccine) control as studied in normal healthy volunteers.
Primary Outcome
Safety will be measured by looking at safety labs, Adverse Events (AEs) and vaccine reactogenicity data from Baseline through Day 211. Immunogenicity will be measured by the peak serum antibody response to the PA transgene defined as the highest toxin-neutralizing antibody (TNA) titer achieved by a subject at any time between the first post-vaccination visit though Day 85 (and Day 211 if Day 85 is positive).
Interventions
- BIOLOGICAL AVA
- BIOLOGICAL Ad4-PA-1
- BIOLOGICAL Ad4-PA-GPI-1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-09 |
| Phase | Phase 1 |
What the finished NCT01979406 record still lists
NCT01979406 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher).
The record links to 0 conditions, and to 3 interventions - of which AVA is the first listed.
NCT01979406 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01979406 about?
NCT01979406 is a clinical study titled "A Phase 1 Ascending Dose Study to Assess the Safety and Immunogenicity of Adenovirus Anthrax Vector Candidate Vaccines". The purpose of this study is to evaluate 2 vaccine candidates against anthrax compared to the positive (vaccine) control as studied in normal healthy volunteers.
What is the current status of trial NCT01979406?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2013-11. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01979406?
The interventions under investigation include: AVA (BIOLOGICAL), Ad4-PA-1 (BIOLOGICAL), Ad4-PA-GPI-1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01979406?
This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01979406's enrollment target sits among peer trials
120 479th of 2000 higher than 1,503 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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