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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: Completed Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove
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 |
What the finished NCT03181789 record still lists
NCT03181789 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (87% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03181789's enrollment target sits among peer trials
56 341st of 542 higher than 200 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
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