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A Clinical Trial in Healthy, HIV-1-Uninfected Adult Participants to Compare the Safety, Tolerability and Immunogenicity of CH505TF gp120 Produced From Stably Transfected Cells to CH505TF gp120 Produced From Transiently Transfected Cells

NCT03856996 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-07-12

Study results available
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Summary

The purpose of this study is to compare the safety, tolerability, and immunogenicity of CH505TF gp120 produced from stably transfected cells to CH505TF gp120 produced from transiently transfected cells in healthy, HIV-1-uninfected adult participants.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

Stable CH505TF gp120

Administered by IM injection in the deltoid of the non-dominant arm

BIOLOGICAL

Transient CH505TF gp120

Administered by IM injection in the deltoid of the non-dominant arm

BIOLOGICAL

Glucopyranosyl Lipid Adjuvant-Stable Emulsion (GLA-SE)

Admixed with Stable CH505TF gp120 or Transient CH505TF gp120 for IM injection in the deltoid of the non-dominant arm

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Greg Wilson · Vanderbilt Medical Center

  • Colleen Kelley · Emory 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
2019-05-23
Primary Completion
2021-03-16
Completion
2021-09-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03856996 on ClinicalTrials.gov