NCT03856996

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

A Phase 1 Double-blind, Randomized, Controlled 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will compare the safety, tolerability, and immunogenicity of two experimental HIV vaccines in healthy, HIV-1-uninfected adult participants. The study vaccines are called Stable CH505TF gp120 and Transient CH505TF gp120. The vaccines are mixed with an adjuvant called GLA-SE. Participants will be randomly assigned to two groups. Participants in Group 1 will receive Stable CH505TF gp120; participants in Group 2 will receive Transient CH505TF. Depending on their group, participants will receive Stable CH505TF gp120 or Transient CH505TF gp120 by injection at Months 0, 2, and 6. Additional study visits will occur at Months 0.5, 2.5, 6.5, 9, and 12. Study visits may include physical examinations, medical history, vaccine injections, blood and urine collection, risk reduction counseling, and questionnaires. Participants will also be contacted for health information at Month 18.

Conditions

• HIV Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-05-23
• Primary completion: 2021-03-16
• Completion: 2021-09-07
• First posted: 2019-02-27
• Last updated: 2024-07-12
• Results posted: 2022-07-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study