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Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA

NCT03181789 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-02-07

Study results available
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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

  • HIV Infections

Interventions

BIOLOGICAL

p24CE1/2 pDNA Vaccine

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

BIOLOGICAL

p55^gag pDNA Vaccine

Administered bilaterally using the TDS-IM EP device

BIOLOGICAL

IL-12 pDNA Adjuvant

Administered bilaterally using the TDS-IM EP device

BIOLOGICAL

Placebo

Administered bilaterally using the TDS-IM EP device

DEVICE

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

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Spyros Kalams · Vanderbilt University

  • Hyman Scott · Bridge HIV, SFDPH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-18
Primary Completion
2019-10-25
Completion
2020-04-29
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03181789 on ClinicalTrials.gov