RECRUITING

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

Conditions

HIV-1 HIV Therapeutic vaccine bNab-inducing vaccine Trimer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2025-04-01

Study Completion:2027-08-13

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06680479

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).

Inclusion Criteria

Exclusion 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).

Contacts and Locations

Principal Investigator

Madhu Choudhary, MD

STUDY_CHAIR

University of Pittsburgh

Study Locations (Sites)

University of California, Los Angeles CARE Center CRS

Los Angeles, California, 90035

United States

UCSD Antiviral Research Center CRS

San Diego, California, 92103

United States

University of California, San Francisco HIV/AIDS CRS

San Francisco, California, 94110

United States

Harbor University of California Los Angeles Center CRS

Torrance, California, 90502-2052

United States

University of Colorado Hospital CRS

Aurora, Colorado, 80045

United States

The Ponce de Leon Center CRS

Atlanta, Georgia, 30308-2012

United States

Northwestern University CRS

Chicago, Illinois, 60611

United States

Johns Hopkins University CRS

Baltimore, Maryland, 21287

United States

Massachusetts General Hospital CRS (MGH CRS)

Boston, Massachusetts, 02114

United States

Washington University Therapeutics (WT) CRS

Saint Louis, Missouri, 63110-1010

United States

New Jersey Medical School Clinical Research Center CRS

Newark, New Jersey, 07103

United States

Weill Cornell Chelsea CRS

New York, New York, 10010

United States

Columbia Physicians & Surgeons (P&S) CRS

New York, New York, 10032

United States

Weill Cornell Uptown CRS

New York, New York, 10065

United States

University of Rochester Adult HIV Therapeutic Strategies Network CRS

Rochester, New York, 14642

United States

Chapel Hill CRS

Chapel Hill, North Carolina, 27599-7215

United States

Greensboro CRS

Greensboro, North Carolina, 27401-1020

United States

Cincinnati CRS

Cincinnati, Ohio, 45267-0405

United States

Case CRS

Cleveland, Ohio, 44106

United States

Ohio State University CRS

Columbus, Ohio, 43210

United States

Penn Therapeutics CRS

Philadelphia, Pennsylvania, 19104

United States

University of Pittsburgh CRS

Pittsburgh, Pennsylvania, 15213

United States

Vanderbilt Therapeutics (VT) CRS

Nashville, Tennessee, 37204

United States

Houston Advancing Research Team CRS

Houston, Texas, 77030

United States

University of Washington Positive Research CRS

Seattle, Washington, 98104

United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Madhu Choudhary, MD, STUDY_CHAIR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01

Study Completion Date2027-08-13

Study Record Updates

Study Start Date2025-04-01

Study Completion Date2027-08-13

Terms related to this study

Keywords Provided by Researchers

HIV
Therapeutic vaccine
bNab-inducing vaccine
Trimer

Additional Relevant MeSH Terms

HIV-1