Safety and Immunogenicity of Stabilized CH505 TF chTrimer Vaccination in Adults Living With HIV-1 on Suppressive Antiretroviral Therapy
Purpose
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).
Condition
- HIV-1
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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).
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- Randomized (2:1), 20 participants in Arm 1 and 10 participants in Arm 2
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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) |
|
Recruiting Locations
Massachusetts General Hospital CRS (MGH CRS)
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)