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NCT01317667 · ClinicalTrials.gov registry record · Phase 1

Safety and Immunogenicity Study of Recombinant Ricin Toxin A-Chain Vaccine (RVEc™)

A Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT01317667: Completed Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.

NCT01317667 is a Phase 1 study that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01317667, a Phase 1 study, has completed, sponsored by U.S. Army Medical Research and Development Command.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

This study is a Phase 1, escalating, multiple-dose, single-center study to evaluate the safety and immunogenicity of the RVEc vaccine. The two principal hypotheses to be tested are: RVEc vaccine will display an acceptable safety profile as determined by adverse event data and RVEc vaccine will elicit ELISA immunoglobulin G (IgG) titers greater than or equal to 1:500 and toxin-neutralizing antibody (TNA) anti-ricin toxin-neutralizing antibody titers greater than or equal to 1:50 in vaccine recipients.

Interventions

  • BIOLOGICAL RVEc

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2011-03
Est. Completion 2014-12
Phase Phase 1

What the finished NCT01317667 record still lists

NCT01317667 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 1 intervention - of which RVEc is the first listed.

NCT01317667 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01317667 about?

NCT01317667 is a clinical study titled "Safety and Immunogenicity Study of Recombinant Ricin Toxin A-Chain Vaccine (RVEc™)". This study is a Phase 1, escalating, multiple-dose, single-center study to evaluate the safety and immunogenicity of the RVEc vaccine. The two principal hypotheses to be tested are: RVEc vaccine will display an acceptable safety profile as determined by adverse event data and RVEc vaccine will elic...

What is the current status of trial NCT01317667?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2011-03. Estimated completion is 2014-12.

What interventions are being tested in trial NCT01317667?

The interventions under investigation include: RVEc (BIOLOGICAL).

Who is sponsoring clinical trial NCT01317667?

This trial is sponsored by U.S. Army Medical Research and Development Command, which has 77 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01317667's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 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 NCT01317667, the US trial registry maintained by the National Library of Medicine. NCT01317667 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.