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
Public ClinicalTrials.gov record NCT01578889. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an IL-12 pDNA Enhanced HIV-1 Multiantigen pDNA Vaccine Delivered Intramuscularly With Electroporation, With an HIV-1 rVSV Vaccine Boost, in Healthy HIV-Uninfected Adult Participants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01578889
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Interventions
- HIV-MAG vaccine Biological
- IL-12 pDNA adjuvant Biological
- VSV HIV gag vaccine Biological
- Placebo Biological
- Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) device Device
Biological · Device
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2012
- Primary completion
- Aug 31, 2014
- Completion
- Sep 30, 2016
- Last update posted
- Oct 14, 2021
2012 – 2016
United States locations
- U.S. sites
- 5
- U.S. states
- 3
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Columbia P&S CRS | New York | New York | 10032-3732 | — |
| New York Blood Center CRS | New York | New York | 10065 | — |
| University of Rochester Vaccines to Prevent HIV Infection CRS | Rochester | New York | 14642 | — |
| Penn Prevention CRS | Philadelphia | Pennsylvania | 19104 | — |
| Vanderbilt Vaccine (VV) CRS | Nashville | Tennessee | 37232-2582 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01578889, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2021 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01578889 live on ClinicalTrials.gov.