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NCT03181789 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA
A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 3
- Study locations
NCT03181789 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 56 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (87% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT03181789, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of two HIV-1 pDNA vaccines: p24CE1/2 pDNA and p55\^gag pDNA administered with IL-12 pDNA adjuvant, given by intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL p24CE1/2 pDNA Vaccine
- BIOLOGICAL p55^gag pDNA Vaccine
- BIOLOGICAL IL-12 pDNA Adjuvant
- DEVICE Ichor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) device
Study Locations (3)
California
- Bridge HIV CRS - San Francisco
Georgia
- The Hope Clinic of the Emory Vaccine Center CRS - Decatur
Ohio
- Case Clinical Research Site - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2017-10-18 |
| Est. Completion | 2020-04-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03181789
The ClinicalTrials.gov registry entry for NCT03181789 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (87% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT03181789 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Georgia, Ohio.
Frequently Asked Questions
What is clinical trial NCT03181789 about?
NCT03181789 is a clinical study titled "Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA". The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of two HIV-1 pDNA vaccines: p24CE1/2 pDNA and p55\^gag pDNA administered with IL-12 pDNA adjuvant, given by intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults.
What is the current status of trial NCT03181789?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2017-10-18. Estimated completion is 2020-04-29.
What conditions does trial NCT03181789 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT03181789?
The interventions under investigation include: Placebo (BIOLOGICAL), p24CE1/2 pDNA Vaccine (BIOLOGICAL), p55^gag pDNA Vaccine (BIOLOGICAL), IL-12 pDNA Adjuvant (BIOLOGICAL), Ichor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) device (DEVICE).
Who is sponsoring clinical trial NCT03181789?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03181789 being conducted?
This trial has 3 study locations across California, Georgia, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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