CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 56 enrolled
Drug / intervention
p24CE1/2 pDNA Vaccine +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03181789
NCT03181789Phase 1Completed
CompareCT.gov

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA, in Healthy, HIV-Uninfected Adult Participants

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jun 9, 2017·Updated Feb 7, 2024

In Brief

A Phase 1 clinical trial evaluating p24CE1/2 pDNA Vaccine, p55^gag pDNA Vaccine, and 3 other interventions for HIV Infections. Completed, enrolled 56 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJun 9, 2017
Enrollment StartOct 18, 2017
Primary CompletionOct 25, 2019
Study CompletionApr 29, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.1 years ago

Interventions

p24CE1/2 pDNA Vaccinebiological

Administered bilaterally using the Ichor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) device

p55^gag pDNA Vaccinebiological

Administered bilaterally using the TDS-IM EP device

IL-12 pDNA Adjuvantbiological

Administered bilaterally using the TDS-IM EP device

Placebobiological

Administered bilaterally using the TDS-IM EP device

Ichor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) devicedevice

The TDS-IM EP device will be used to administer study product(s).