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NCT01142362 · ClinicalTrials.gov registry record · Phase 1
Study of VGX-3400X, H5N1 Avian Influenza Virus DNA Plasmid + Electroporation in Healthy Adults
A Phase 1 study of Healthy, sponsored by Inovio Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 2
- Study locations
NCT01142362: Completed Phase 1 study of Healthy, sponsored by Inovio Pharmaceuticals.
NCT01142362 is a Phase 1 study of Healthy that has completed, run by Inovio Pharmaceuticals. The registered enrollment target is 32 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01142362, a Phase 1 study of Healthy, has completed, sponsored by Inovio Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 2
- Study locations
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, VGX-3400X, 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 30 healthy adult subjects. It is hypothesized that VGX-3400X + 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.
Conditions Studied
Interventions
- BIOLOGICAL VGX-3400X
Study Locations (2)
Kansas
- Vince & Associates - Overland Park
Maryland
- Accelovance - Rockville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-11 |
| Phase | Phase 1 |
What the finished NCT01142362 record still lists
NCT01142362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which VGX-3400X is the first listed.
NCT01142362 reports a single indexed study location in Kansas, Maryland.
Frequently Asked Questions
What is clinical trial NCT01142362 about?
NCT01142362 is a clinical study titled "Study of VGX-3400X, H5N1 Avian Influenza Virus DNA Plasmid + Electroporation in Healthy Adults". 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, VGX-3400X, which includes plasmids targeting the proteins...
What is the current status of trial NCT01142362?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2010-06. Estimated completion is 2011-11.
What conditions does trial NCT01142362 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01142362?
The interventions under investigation include: VGX-3400X (BIOLOGICAL).
Who is sponsoring clinical trial NCT01142362?
This trial is sponsored by Inovio Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01142362 being conducted?
This trial has 2 study locations across Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01142362's enrollment target sits among peer trials
32 647th of 1090 higher than 418 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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