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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.

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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

FieldValue
Enrollment Target 120 participants
Start Date 2013-11
Est. Completion 2015-09
Phase Phase 1
Emergent BioSolutions

34 total trials

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.

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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Source: ClinicalTrials.gov NCT01979406, the US trial registry maintained by the National Library of Medicine. NCT01979406 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.