Safety and Immunogenicity of Stabilized CH505 TF chTrimer Vaccination in Adults Living With HIV-1 on Suppressive Antiretroviral Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2028-04-14

Brief Summary

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A5422 is a phase 1, randomized, double-blind, placebo-controlled clinical trial to assess the safety, tolerability, and immunogenicity of a vaccination with stabilized CH505 TF chTrimer admixed with 3M-052-AF + Aluminum hydroxide (Alum), to assess the effect of CH505 TF chTrimer vaccine as a therapeutic vaccine in adults living with HIV-1 on suppressive antiretroviral therapy (ART) with the aim of inducing new HIV-1 Envelope (Env) B-cell neutralizing immune responses. Participants will be on study for up to 100 weeks (52 weeks on study treatment plus 48 weeks follow-up).

Detailed Description

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Conditions

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HIV-1

Keywords

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HIV Therapeutic vaccine bNab-inducing vaccine Trimer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Randomized (2:1), 20 participants in Arm 1 and 10 participants in Arm 2

Study Groups

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Study Arm 1: CH505 TF chTrimer (300 mcg) admixed with 3M-052-AF (3 mcg) and Alum (500 mcg)

Group Type EXPERIMENTAL

CH505 TF chTrimer

Intervention Type BIOLOGICAL

Stabilized CH505 TF chTrimer, 300 mcg

3M-052-AF

Intervention Type BIOLOGICAL

3 mcg

Aluminum Hydroxide Suspension

Intervention Type BIOLOGICAL

500 mcg

Study Arm 2: Placebo (sodium chloride for injection, 0.9% USP)

Group Type PLACEBO_COMPARATOR

Sodium Chloride for Injection

Intervention Type OTHER

Sodium chloride for injection, 0.9% USP volume-matched placebo injection.

Interventions

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CH505 TF chTrimer

Stabilized CH505 TF chTrimer, 300 mcg

Intervention Type BIOLOGICAL

3M-052-AF

3 mcg

Intervention Type BIOLOGICAL

Aluminum Hydroxide Suspension

500 mcg

Intervention Type BIOLOGICAL

Sodium Chloride for Injection

Sodium chloride for injection, 0.9% USP volume-matched placebo injection.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* HIV-1 infection
* On a suppressive ART regimen for at least 24 months with no changes in the 90 days prior to study entry
* CD4+ cell count greater than 200 cells/mm3 obtained within 56 days prior to study entry
* HIV-1 RNA \<200 copies/mL obtained within 56 days prior to study entry
* Plasma HIV-1 RNA levels \<200 copies/mL for at least 12 months on ART prior to study entry
* The following laboratory values obtained within 56 days prior to study entry

* White blood cell count ≥2,500 cells/mm3
* Absolute neutrophil count (ANC) \>750/mm3
* Hemoglobin ≥11 g/dL for cisgender men/transgender women and ≥10 g/dL for cisgender women/transgender men
* Platelet count ≥100,000/mm3
* Creatinine \<1.5x upper limit of normal (ULN)
* Alanine aminotransferase (ALT) (SGPT) ≤1.5 ULN
* Hepatitis C Virus (HCV) antibody-negative or HCV RNA negative result if indicated, within 56 days prior to study entry
* Negative hepatitis B surface antigen (HBsAg) result obtained within 56 days prior to study entry
* For study candidates of child-bearing potential, negative serum or urine pregnancy test at screening and within 48 hours prior to study entry
* No participation in conception process and agree to use at least one reliable form of contraception if participating in sexual activity that could lead to pregnancy during the study and for 8 weeks following the final study vaccine

Exclusion Criteria

* Known to have started ART during acute HIV infection
* Known to have HIV-related opportunistic infections within the last 2 years prior to study entry.
* History of malignancy within the last 5 years prior to study entry.
* Currently breastfeeding
* History of or active autoimmune disorders
* HIV vaccination (prophylactic and/or therapeutic) within 1 year prior to study entry
* Receipt of any anti-HIV-1 bNAbs within 2 years prior to study entry
* Vaccination within 4 weeks prior to study entry
* Use of any infusion blood product or immune globulin within 16 weeks prior to study entry (Exception: COVID-19-specific monoclonal antibodies are allowed)
* Use of systemic immunomodulators, systemic cytotoxic chemotherapy, or non-FDA approved investigational therapy within 60 days prior to study entry
* Intent to use immunomodulators during the course of the study
* Immune deficiency other than HIV
* HCV antiviral therapy within 90 days prior to screening
* Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation
* Active drug or alcohol use or dependence that would interfere with adherence to study requirements
* Acute or serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry
* Conditions that would preclude injection site reaction assessments (e.g., extensive tattoos, scarring, skin conditions).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Madhu Choudhary, MD

Role: STUDY_CHAIR

University of Pittsburgh

Houston, Texas, United States

Site Status NOT_YET_RECRUITING

University of Washington Positive Research CRS

Seattle, Washington, United States

Site Status NOT_YET_RECRUITING

Countries

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Identifier Type: OTHER

Identifier Source: secondary_id

A5422

Identifier Type: -

Identifier Source: org_study_id

Safety and Immunogenicity of Stabilized CH505 TF chTrimer Vaccination in Adults Living With HIV-1 on Suppressive Antiretroviral Therapy

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Study Arm 1: CH505 TF chTrimer (300 mcg) admixed with 3M-052-AF (3 mcg) and Alum (500 mcg)

CH505 TF chTrimer

3M-052-AF

Aluminum Hydroxide Suspension

Study Arm 2: Placebo (sodium chloride for injection, 0.9% USP)

Sodium Chloride for Injection

Interventions

CH505 TF chTrimer

3M-052-AF

Aluminum Hydroxide Suspension

Sodium Chloride for Injection

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Duke University

Access to Advanced Health Institute (AAHI)

National Institute of Allergy and Infectious Diseases (NIAID)

Responsible Party

Principal Investigators

Madhu Choudhary, MD

Locations

University of California, Los Angeles CARE Center CRS

UCSD Antiviral Research Center CRS

University of California, San Francisco HIV/AIDS CRS

Harbor University of California Los Angeles Center CRS

University of Colorado Hospital CRS

The Ponce de Leon Center CRS

Northwestern University CRS

Johns Hopkins University CRS

Massachusetts General Hospital CRS (MGH CRS)

Washington University Therapeutics (WT) CRS

New Jersey Medical School Clinical Research Center CRS

Weill Cornell Chelsea CRS

Columbia Physicians & Surgeons (P&S) CRS

Weill Cornell Uptown CRS

University of Rochester Adult HIV Therapeutic Strategies Network CRS

Chapel Hill CRS

Greensboro CRS

Cincinnati CRS

Case CRS

Ohio State University CRS

Penn Therapeutics CRS

University of Pittsburgh CRS

Vanderbilt Therapeutics (VT) CRS

Houston Advancing Research Team CRS

University of Washington Positive Research CRS

Countries

Facility Contacts

Aleen Khodabakhshian

Steven Hendrickx

Jay Dwyer

Mario Guerrero

Nicola Haakonsen

Ericka R. Patrick

Baiba Berzins

Rebecca L. Becker

Amy Sbrolla

Michael Klebert

Christie Lyn Costanza

Rebecca Fry

Anyelina Cantos

Jonathan Berardi

Susan Hulse

Erin Elizabeth Hoffman

Kim Epperson

Michelle Saemann

Julie Pasternak

Lindsay Summers

Erin Logue-Chamberlain

Stacey Edick