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NCT01578889 · ClinicalTrials.gov registry record · Phase 1
Evaluating the Safety of and Immune Response to HIV-MAG DNA Vaccine With or Without Plasmid IL-12 Adjuvant Delivered Intramuscularly Via Electroporation Followed by VSV-gag HIV Vaccine Boost in Healthy, HIV-Uninfected Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT01578889: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01578889 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01578889, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study Summary
Some vaccines may work better when given together with another substance known as an adjuvant or when given with an experimental procedure called electroporation (EP). EP is a method where an electric pulse is administered to the same muscle where the vaccine injection is given. The addition of the adjuvant to the vaccine and the delivery with EP may increase a person's immune response to the vaccine. Combination approaches such as a DNA vaccine followed by live vector boost may also increase a person's immune response to the vaccine components. All of these interventions will be tested in this study. This study will evaluate the safety and tolerability of and immune response to an HIV DNA vaccine with or without plasmid IL-12 adjuvant, when given by EP and followed by a live vector vaccine given IM by needle and syringe in healthy, HIV-uninfected adults.
Primary Outcome
Pain, tenderness, erythema, induration, and maximum severity of pain and/or tenderness
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL IL-12 pDNA adjuvant
- BIOLOGICAL HIV-MAG vaccine
- BIOLOGICAL VSV HIV gag vaccine
- DEVICE Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2012-05 |
| Est. Completion | 2016-10 |
| Phase | Phase 1 |
What the finished NCT01578889 record still lists
NCT01578889 is an interventional study that assigns participants to a tested intervention. The registered 100 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 (67% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01578889 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01578889 about?
NCT01578889 is a clinical study titled "Evaluating the Safety of and Immune Response to HIV-MAG DNA Vaccine With or Without Plasmid IL-12 Adjuvant Delivered Intramuscularly Via Electroporation Followed by VSV-gag HIV Vaccine Boost in Healthy, HIV-Uninfected Adults". Some vaccines may work better when given together with another substance known as an adjuvant or when given with an experimental procedure called electroporation (EP). EP is a method where an electric pulse is administered to the same muscle where the vaccine injection is given. The addition of the ...
What is the current status of trial NCT01578889?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2012-05. Estimated completion is 2016-10.
What interventions are being tested in trial NCT01578889?
The interventions under investigation include: Placebo (BIOLOGICAL), IL-12 pDNA adjuvant (BIOLOGICAL), HIV-MAG vaccine (BIOLOGICAL), VSV HIV gag vaccine (BIOLOGICAL), Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) device (DEVICE).
Who is sponsoring clinical trial NCT01578889?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01578889's enrollment target sits among peer trials
100 546th of 2000 higher than 1,411 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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