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Adjuvant

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

Phase 1

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at months 2.5 and 6.5

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

HIV Suppression
Human Immunodeficiency Virus Infection

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at months 2.5 and 6.5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at months 2.5 and 6.5

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at months 2.5 and 6.5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events of Special Interest (AESIs)

Area Under Titration Curve of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins

Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L

+9 more

Secondary study objectives

Neutralization Titers of nAB Responses Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods

Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2: Transient CH505TF gp120 + GLA-SEExperimental Treatment2 Interventions

Participants in Group 2 will receive 100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE by IM injection at Months 0, 2, and 6.

Group II: Group 1: Stable CH505TF gp120 + GLA-SEExperimental Treatment2 Interventions

Participants in Group 1 will receive 100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE by intramuscular (IM) injection at Months 0, 2, and 6.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stable CH505TF gp120

2019

Completed Phase 1

~30

Transient CH505TF gp120

2019

Completed Phase 1

~30