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

About

Brief 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).

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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).