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Evaluating the Safety and Immunogenicity of Polyvalent DNA/gp120 HIV Vaccine in Healthy, HIV-uninfected Adults

NCT04927585 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-04-09

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of polyvalent env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein vaccines (PDPHV201401) co-administered together with or without adjuvant in repeated doses in healthy, HIV-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

GLA-SE adjuvant

Administered by intramuscular injection in the deltoid.

BIOLOGICAL

Placebo

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

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Access to Advanced Health Institute (AAHI)

    collaborator OTHER

  • Worcester HIV Vaccine

    lead INDUSTRY

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
2021-07-08
Primary Completion
2023-12-07
Completion
2023-12-07
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 NCT04927585 on ClinicalTrials.gov