Uvax Bio has received approval from the Australian Human Research Ethics Committee (HREC) to commence a Phase I clinical trial of its HIV-1 vaccine candidates in healthy subjects in the country. 

For the trial, which is anticipated to commence in January next year, the company will collaborate with regional clinical research partners Avance Clinical and the Nucleus Network study site.

The company will evaluate the two vaccines, UVAX-1197 and UVAX-1107, which leverage its 1c-SApNP technology, presenting 20 uncleaved, prefusion-optimised (UFO) HIV envelope (Env) trimers in wild-type and glycan-trimmed forms, respectively. 

Intended for active vaccination to prevent HIV-1 infection, the vaccines will also contain CpG 1018 adjuvant and aluminium hydroxide.

The trial will enrol 34 healthy adult participants to evaluate the safety of two varying regimes of the vaccines.

Assessing the reactogenicity, safety, and immunogenicity of the vaccines following the primary vaccination and booster dose regimen will be the trial’s primary endpoints.

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In addition, the trial will analyse if one of the vaccines or their combination can induce the ideal immunological response in trial subjects.

UVAX-1107 and 1197, plus CpG 1018 and aluminium hydroxide, were demonstrated to be safe in preclinical toxicology research, without any serious adverse events. 

This data is in line with those of already approved protein-based vaccines.

In another preclinical immunogenicity study, the HIV-1 vaccine candidates were shown to induce strong neutralising antibody responses against the vaccine-matched virus in 99% of the animals. 

Uvax Bio CEO Ji Li said: “The body of evidence from our preclinical studies and GMP manufacturing runs was instrumental in facilitating this authorisation to begin preparation for our first Phase I trial. 

“Our clinical team will immediately begin the preparation to initiate this trial in January 2024.”

The company focuses on the development and marketing of prophylactic vaccines for various infectious diseases. It has a portfolio comprising 12 patented vaccine candidates in the preclinical stage.