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