Current Studies

HIV Vaccine Studies

In the United States HIV disproportionately affects certain groups and populations; however, HIV can affect anyone. Worldwide there are currently over 40 million people living with HIV. That number is growing.

The Vanderbilt HIV Vaccine Program is looking for healthy adults (ages 18-55) from all walks of life who are not living with HIV to participate in an HIV prevention study.

You cannot get HIV from participating in the study.

Volunteers must be available locally for approximately 12 months. Volunteers will be compensated.

You can help fight the HIV/AIDS epidemic

Call 615-936-7327 or email vic.sorrell@vumc.org for more information.

In order to develop HIV prevention methods that will work for everyone, we need help from everyone!

ALL RACIAL AND ETHNIC GROUPS ARE ENCOURAGED TO CONTACT OUR PROGRAM.

(www.hivvaccineresearch.com)

Current Studies

HVTN 144: is a Phase 1/2 clinical trial evaluating the safety and immunogenicity of an HIV-1 vaccine regimen using adenovirus vectors. The study assesses the ability of the vaccine to induce strong antibody and T-cell responses, with the goal of offering broad protection against multiple HIV-1 subtypes. HVTN 206: is a phase 1 clinical trial to evaluate the safety, pharmacokinetics, and in vitro neutralization of ePGT121v1-LS, VRC07-523LS, and PGDM1400LS administered in multiple doses, and routes to adult participants without HIV-1. HVTN 307: is a Phase 1 clinical trial evaluating the safety and immunogenicity of a novel HIV-1 vaccine regimen using lipid nanoparticle-encapsulated mRNA technology. The study aims to assess the vaccine’s ability to elicit broad and potent antibody and T-cell responses to prevent HIV-1 infection across diverse viral strains. HVTN 318: is a phase 1 open-label. Non-randomized, clinical trial to evaluate the safety and immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in adult participants who previously participated in the HVTN706/MOSAICO study and remain without HIV. HVTN 319: is a Phase 1 clinical trial designed to evaluate the safety, tolerability, and immunogenicity of an HIV-1 vaccine regimen based on mosaic and trimeric antigens. The trial aims to determine the vaccine’s ability to elicit broad, cross-clade antibody and T-cell responses to protect against diverse HIV-1 strains. HVTN 321: is the first-in-human (FIH) phase 1 open-label clinical trial will evaluate a prime-boost regimen of immunogens designed to induce multiple specificities of HIV-1 envelope (Env) V3-glyca-specific broadly neutralizing antibodies (V3G bnAbs). Both vaccine components consist of a modified messenger RNA (mRNA) encapsulated in lipid nanoparticles (LNPs) that, when translated in cells, produces HIV-1 Env gp150 transmembrane trimers and will be administered in a dose-escalation approach. (An upcoming study is HVTN 141, projected to open in Q1 of 2026.)

Upcoming Studies

HVTN 309: A phase 1 clinical trial in adult participants without HIV and in overall good health to evaluate the safety and immunogenicity of CD4BS CH505M5 Pr-NP1 followed by CH505 TF chTrimer boost both adjuvanted with either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum

HVTN 318: A Phase 1 open-label, non-randomized clinical trial to evaluate the safety and immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in adult participants who previously participated in the HVTN706/MOSAICO study and remain without HIV. (Projected start September 2025)

HVTN 321: A first-in-human (FIH) Phase 1 open-label clinical trial evaluating a prime-boost regimen of immunogens designed to induce multiple specificities of HIV-1 envelope (Env) V3-glyca-specific broadly neutralizing antibodies (V3G bnAbs). Both vaccine components consist of modified mRNA encapsulated in lipid nanoparticles (LNPs) that, when translated in cells, produce HIV-1 Env gp150 transmembrane trimers and will be administered in a dose-escalation approach.

HVTN 318: A Phase 1 open-label clinical trial to evaluate the safety and immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env in adult participants who previously participated in the HVTN706/MOSAICO study and remain without HIV.

HVTN 321: A Phase 1 clinical trial to evaluate the safety and immunogenicity of the V3 region-directed immunogens DV700P-RNA (prime) followed by DV701B1/1-RNA (boost) in adult participants without HIV.

HVTN 206: A randomized, double-blind, controlled, Phase 2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS broadly neutralizing monoclonal antibodies given intravenously in adult participants without HIV.