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

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California, Los Angeles CARE Center CRS
NOT_YET_RECRUITING
Los Angeles
UCSD Antiviral Research Center CRS
NOT_YET_RECRUITING
San Diego
University of California, San Francisco HIV/AIDS CRS
NOT_YET_RECRUITING
San Francisco
Harbor University of California Los Angeles Center CRS
NOT_YET_RECRUITING
Torrance
Colorado
University of Colorado Hospital CRS
RECRUITING
Aurora
Georgia
The Ponce de Leon Center CRS
NOT_YET_RECRUITING
Atlanta
Illinois
Northwestern University CRS
NOT_YET_RECRUITING
Chicago
Massachusetts
Massachusetts General Hospital CRS (MGH CRS)
RECRUITING
Boston
Maryland
Johns Hopkins University CRS
NOT_YET_RECRUITING
Baltimore
Missouri
Washington University Therapeutics (WT) CRS
NOT_YET_RECRUITING
St Louis
North Carolina
Chapel Hill CRS
NOT_YET_RECRUITING
Chapel Hill
Greensboro CRS
NOT_YET_RECRUITING
Greensboro
New Jersey
New Jersey Medical School Clinical Research Center CRS
NOT_YET_RECRUITING
Newark
New York
Columbia Physicians & Surgeons (P&S) CRS
NOT_YET_RECRUITING
New York
Weill Cornell Chelsea CRS
RECRUITING
New York
Weill Cornell Uptown CRS
NOT_YET_RECRUITING
New York
University of Rochester Adult HIV Therapeutic Strategies Network CRS
NOT_YET_RECRUITING
Rochester
Ohio
Cincinnati CRS
RECRUITING
Cincinnati
Case CRS
NOT_YET_RECRUITING
Cleveland
Ohio State University CRS
NOT_YET_RECRUITING
Columbus
Pennsylvania
Penn Therapeutics CRS
RECRUITING
Philadelphia
University of Pittsburgh CRS
NOT_YET_RECRUITING
Pittsburgh
Tennessee
Vanderbilt Therapeutics (VT) CRS
NOT_YET_RECRUITING
Nashville
Texas
Houston Advancing Research Team CRS
NOT_YET_RECRUITING
Houston
Washington
University of Washington Positive Research CRS
NOT_YET_RECRUITING
Seattle
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2027-08-13
Participants
Target number of participants: 30
Treatments
Experimental: Study Arm 1: CH505 TF chTrimer (300 mcg) admixed with 3M-052-AF (3 mcg) and Alum (500 mcg)
Placebo_comparator: Study Arm 2: Placebo (sodium chloride for injection, 0.9% USP)
Related Therapeutic Areas
Sponsors
Leads: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Access to Advanced Health Institute (AAHI), Duke University

This content was sourced from clinicaltrials.gov

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