Uvax Bio, a clinical-stage vaccine company, has announced interim results from its Phase 1 clinical trial of the HIV-1 vaccine candidates UVAX-1107 and UVAX-1197. The trial, conducted in healthy volunteers in Australia, evaluated the safety and immunogenicity of the vaccines. Interim analysis showed that UVAX-1107 was well-tolerated and induced robust antibody responses after two priming doses.
The first stage of the trial involved subjects receiving either UVAX-1107 adjuvanted with CpG 1018® (Dynavax) and aluminum hydroxide or a placebo. UVAX-1107 utilizes Uvax Bio’s 1c-SApNP® vaccine development platform to generate virus-like particles (VLPs), closely resembling the target virus in size and shape. These VLPs display 20 copies of the native-like, prefusion-stabilized trimeric HIV-1 antigen.
Safety and Tolerability
According to Pedro Garbes, M.D., Vice President and Global Clinical Lead of Uvax Bio, the UVAX-1107 vaccine was well-tolerated at all doses, with no vaccine-related serious adverse events reported. Local and systemic adverse events were mild to moderate, transient, and resolved within two days, aligning with expectations for an adjuvanted protein-based vaccine.
Immunogenicity
The interim analysis demonstrated that UVAX-1107 was immunogenic, generating robust IgG responses to the vaccine antigen derived from the HIV-1 strain BG505. Notably, 100% of subjects in the vaccine group exhibited antibody responses after two priming vaccinations. Antibody response titers increased >200-fold 14 days after the second dose compared to the same period following the first dose.
UVAX-HIV-101 Trial Details
The UVAX-HIV-101 trial (ClinicalTrials.gov ID NCT06541093) is evaluating two different regimens of UVAX-1107 and UVAX-1197 vaccines in 34 healthy adult volunteers. The primary endpoints focus on measuring the safety and immunogenicity of the vaccines after priming and boosting dose series. The study also aims to determine whether either vaccine, or a combination, produces the optimal immunological response. Topline data from a second interim analysis after the first booster vaccination is expected in the first quarter of 2025.
Addressing the Unmet Need for an HIV Vaccine
Globally, there remains a significant unmet need for a vaccine to protect against HIV-1 infection. The Joint United Nations Programme on HIV/AIDS estimates that 39 million people worldwide are living with HIV. The World Health Organization (WHO) reports that approximately 1.3 million new HIV infections occur annually, with 9.2 million people living with HIV not receiving treatment. The majority of new infections stem from undiagnosed or undertreated HIV patients.
About UVAX-1107 and UVAX-1197
The UVAX-1197 HIV-1 vaccine, like UVAX-1107, is designed using Uvax Bio’s 1c-SApNP® technology. These vaccines utilize uncleaved prefusion-optimized (UFO) HIV-1 envelope (Env) trimers displayed on a self-assembled, multi-layered protein nanoparticle. UVAX-1107 incorporates “glycan-trimming” to enhance access to conserved neutralizing epitopes on HIV-1 Env. This glycan trimming strategy was recognized as one of the Top Ten Emerging Technologies in Chemistry for 2023 by the International Union of Pure and Applied Chemistry (IUPAC).
