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Evaluating the Safety and Immunogenicity of Env (A,B,C,A/E)/Gag (C) DNA and gp120 (A,B,C,A/E) Protein/GLA-SE HIV Vaccines, Given Individually or Co-administered, in Healthy, HIV-1-Uninfected Adults

NCT03409276 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-04-25

Study results available
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Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein/GLA-SE HIV-1 vaccines (PDPHV-201401) as a prime-boost regimen or co-administered in repeated doses, in healthy, HIV-1-uninfected adults.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

env (A,B,C,A/E)/gag (C) DNA Vaccine

Administered by intramuscular injection in the deltoid.

BIOLOGICAL

gp120 (A,B,C,A/E) Protein Vaccine

Administered by intramuscular injection in the deltoid.

BIOLOGICAL

Placebo

Sodium Chloride for Injection, USP 0.9%; Administered by intramuscular injection in the deltoid.

BIOLOGICAL

GLA-SE adjuvant

Administered by intramuscular injection in the deltoid.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Ian Frank · University of Pennsylvania

  • Turner Overton · University of Alabama at Birmingham

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
2018-03-16
Primary Completion
2020-05-11
Completion
2020-10-22
FDA Drug
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 NCT03409276 on ClinicalTrials.gov