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

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).