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Evaluating the Safety and Immunogenicity of a Prime-boost Vaccine Regimen of GEO-D02 DNA and MVA/HIV62B With and Without B63521^11 gp120 and IHV01 gp120 Env Proteins in Healthy, HIV-uninfected Adult Participants

NCT04041674 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-10-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and immunogenicity of a prime-boost vaccine regimen of GEO-D02 DNA and MVA/HIV62B with and without B63521\^11 gp120 and IHV01 gp120 Env proteins in healthy, HIV-uninfected adult participants.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

GEO-D02 DNA

Administered by IM injection into the vastus lateralis

BIOLOGICAL

MVA/HIV62B Vaccine

Administered by IM injection into the vastus lateralis

BIOLOGICAL

B63521^11 gp120

Administered as a IM or SC injection into the vastus lateralis or overlying subcutaneous tissue as the MVA dose

BIOLOGICAL

IHV01 Protein

Administered as a IM or SC injection into the vastus lateralis or overlying subcutaneous tissue as the MVA dose

BIOLOGICAL

Protein Placebo

Sodium Chloride for Injection, 0.9% USP Administered as a IM or SC injection into the vastus lateralis or overlying subcutaneous tissue as the MVA dose

Sponsors & Collaborators

  • HIV Vaccine Trials Network (HVTN), Fred Hutch / University of Washington

    collaborator UNKNOWN

  • GeoVax Labs, Inc

    collaborator UNKNOWN

  • Duke University

    collaborator OTHER

  • University of Maryland, Baltimore

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Michael Keefer · University of Rochester

  • Mark Pilkinton · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2022-09-30
Completion
2023-05-31
FDA Drug
Yes

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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 NCT04041674 on ClinicalTrials.gov