safety and immunogenicity of stabilized ch505 tf chtrimer vaccination in adults living with hiv-1 on suppressive antiretroviral therapy

Conditions: HIV-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 criteria:
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).

Keywords: hiv therapeutic vaccine bnab-inducing vaccine trimer