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

Description

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).

Conditions

HIV-1

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
HIV-1
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of California, Los Angeles CARE Center CRS, Los Angeles, California, United States, 90035

San Diego

UCSD Antiviral Research Center CRS, San Diego, California, United States, 92103

San Francisco

University of California, San Francisco HIV/AIDS CRS, San Francisco, California, United States, 94110

Torrance

Harbor University of California Los Angeles Center CRS, Torrance, California, United States, 90502-2052

Aurora

University of Colorado Hospital CRS, Aurora, Colorado, United States, 80045

Atlanta

The Ponce de Leon Center CRS, Atlanta, Georgia, United States, 30308-2012

Chicago

Northwestern University CRS, Chicago, Illinois, United States, 60611

Baltimore

Johns Hopkins University CRS, Baltimore, Maryland, United States, 21287

Boston

Massachusetts General Hospital CRS (MGH CRS), Boston, Massachusetts, United States, 02114

Saint Louis

Washington University Therapeutics (WT) CRS, Saint Louis, Missouri, United States, 63110-1010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

National Institute of Allergy and Infectious Diseases (NIAID),

Madhu Choudhary, MD, STUDY_CHAIR, University of Pittsburgh

Study Record Dates

2027-08-13