Safety and Immunogenicity of Stabilized CH505 TF chTrimer Vaccination in Adults Living With HIV-1 on Suppressive Antiretroviral Therapy
NCT ID: NCT06680479
Last Updated: 2025-12-31
Study Results
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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SUSPENDED
PHASE1
30 participants
INTERVENTIONAL
2025-04-01
2028-04-14
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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)
CH505 TF chTrimer
Stabilized CH505 TF chTrimer, 300 mcg
3M-052-AF
3 mcg
Aluminum Hydroxide Suspension
500 mcg
Study Arm 2: Placebo (sodium chloride for injection, 0.9% USP)
Sodium Chloride for Injection
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
3M-052-AF
3 mcg
Aluminum Hydroxide Suspension
500 mcg
Sodium Chloride for Injection
Sodium chloride for injection, 0.9% USP volume-matched placebo injection.
Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Access to Advanced Health Institute (AAHI)
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Madhu Choudhary, MD
Role: STUDY_CHAIR
University of Pittsburgh
Locations
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University of California, Los Angeles CARE Center CRS
Los Angeles, California, United States
UCSD Antiviral Research Center CRS
San Diego, California, United States
University of California, San Francisco HIV/AIDS CRS
San Francisco, California, United States
Harbor University of California Los Angeles Center CRS
Torrance, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
The Ponce de Leon Center CRS
Atlanta, Georgia, United States
Northwestern University CRS
Chicago, Illinois, United States
Johns Hopkins University CRS
Baltimore, Maryland, United States
Massachusetts General Hospital CRS (MGH CRS)
Boston, Massachusetts, United States
Washington University Therapeutics (WT) CRS
St Louis, Missouri, United States
New Jersey Medical School Clinical Research Center CRS
Newark, New Jersey, United States
Weill Cornell Chelsea CRS
New York, New York, United States
Columbia Physicians & Surgeons (P&S) CRS
New York, New York, United States
Weill Cornell Uptown CRS
New York, New York, United States
University of Rochester Adult HIV Therapeutic Strategies Network CRS
Rochester, New York, United States
Chapel Hill CRS
Chapel Hill, North Carolina, United States
Greensboro CRS
Greensboro, North Carolina, United States
Cincinnati CRS
Cincinnati, Ohio, United States
Case CRS
Cleveland, Ohio, United States
Ohio State University CRS
Columbus, Ohio, United States
Penn Therapeutics CRS
Philadelphia, Pennsylvania, United States
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, United States
Vanderbilt Therapeutics (VT) CRS
Nashville, Tennessee, United States
Houston Advancing Research Team CRS
Houston, Texas, United States
University of Washington Positive Research CRS
Seattle, Washington, United States
Countries
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Other Identifiers
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39037
Identifier Type: OTHER
Identifier Source: secondary_id
A5422
Identifier Type: -
Identifier Source: org_study_id