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NCT01403155 · ClinicalTrials.gov registry record · Phase 1

A Follow-On Study With an H5 Influenza Vaccine for Subjects Who Participated in Study FLU-001

A Phase 1 study, sponsored by Inovio Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
22
Enrollment target

NCT01403155: Completed Phase 1 study, sponsored by Inovio Pharmaceuticals.

NCT01403155 is a Phase 1 study that has completed, run by Inovio Pharmaceuticals. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01403155, a Phase 1 study, has completed, sponsored by Inovio Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
22 participants
Enrollment target

Study Summary

DNA vaccines consist of small pieces of DNA also known as plasmids, and have several potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well tolerated in humans. The investigators have developed a DNA vaccine, INO-3401, which includes plasmids targeting the proteins of the H5N1 avian influenza virus. The vaccine will be delivered via electroporation (EP) which uses the CELLECTRA constant current device to deliver a small electric charge following injection, since animal studies have shown that this delivery method increases the immune response to vaccine. The vaccine will be given to up 30 healthy adult subjects who have participated in study FLU-001. It is hypothesized that a booster dose with INO-3401 + EP will be well tolerated and immunogenic.

Primary Outcome

Frequency and severity of local and systemic reactogenicity, signs and symptoms, adverse events and serious adverse events.

Interventions

  • BIOLOGICAL INO-3401 + EP

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2011-05
Est. Completion 2012-08
Phase Phase 1
Inovio Pharmaceuticals

28 total trials

What the finished NCT01403155 record still lists

NCT01403155 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).

The record links to 0 conditions, and to 1 intervention - of which INO-3401 + EP is the first listed.

NCT01403155 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01403155 about?

NCT01403155 is a clinical study titled "A Follow-On Study With an H5 Influenza Vaccine for Subjects Who Participated in Study FLU-001". DNA vaccines consist of small pieces of DNA also known as plasmids, and have several potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well tolerated in humans. The investigators have developed a DNA vaccine, INO-3401, which includes plasmids targeting the proteins ...

What is the current status of trial NCT01403155?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2011-05. Estimated completion is 2012-08.

What interventions are being tested in trial NCT01403155?

The interventions under investigation include: INO-3401 + EP (BIOLOGICAL).

Who is sponsoring clinical trial NCT01403155?

This trial is sponsored by Inovio Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01403155's enrollment target sits among peer trials

22 1601st of 2000 higher than 386 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 NCT01403155, the US trial registry maintained by the National Library of Medicine. NCT01403155 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.