Uvax Bio, LLC, a reputable clinical-stage vaccine company, has recently received approval from the Australian Therapeutic Goods Administration and the Human Research Ethics Committee (HREC) to conduct an upcoming Phase 1 study of their promising HIV-1 vaccine candidates. Uvax Bio's HIV-1 vaccines are combined with CpG 1018® adjuvant and aluminium hydroxide, which demonstrates enormous potential in the fight against HIV.
{alcircleadd}This study is expected to commence in January 2024, and Uvax Bio is pleased to be collaborating with their esteemed clinical research partners, Avance Clinical and the Nucleus Network study site.
Uvax Bio LLC's flagship 1c-SApNP® technology
The company has developed two innovative vaccines utilising its proprietary 1c-SApNP® technology, which are presently undergoing testing. These vaccines incorporate 20 uncleaved, prefusion-optimised (UFO) HIV envelope (Env) trimers in both wildtype and glycan-trimmed forms, called UVAX-1197 and UVAX-1107, respectively.
Use of aluminium hydroxide in vaccine production
This is an incredible breakthrough in the field of vaccine development! Preclinical studies have shown that UVAX-1107 & 1197 combined with CpG 1018® and aluminium hydroxide are safe and well-tolerated, with minimal or nil harmful incidents recorded. It is truly amazing to become familiar with the most intricate medicinal applications of aluminium, as it makes us wonder about the true potential of this most abundantly found non-ferrous material on the earth's crust. Aluminium Hydroxide is conventionally used in antacids.
Additionally, Uvax Bio's HIV-1 vaccine candidates have elicited robust neutralising antibody responses in 99% of animals, paving the way for even more exciting advancements in the future. These results are truly inspiring and offer hope for a healthier, safer world for all.
Words from Uvax Bio's CEO
The CEO of Uvax Bio, Ji Li, PhD, illustrated: "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 1 trial."
"Our clinical team will immediately begin the preparation to initiate this trial in January 2024," he concluded positively.
Footnote on the ongoing Research and Development (R&D)
The study is fundamental in determining the safety and efficacy of two different regimens of UVAX-1107 and UVAX-1197 vaccines designed to prevent HIV-1 infection. Both vaccines utilise Uvax Bio's 1c-SApNP® platform and are intended for active immunisation. While UVAX-1197 retains the virus' "wildtype" glycan shield, UVAX-1107 has a portion of the glycan shield removed through "glycan trimming" to allow better access to the conserved neutralising epitopes on HIV-1 Env.
Selected Individuals for initial tests
The study will administer the Uvax Bio HIV-1 vaccines to 34 healthy adult subjects and measure the safety, reactogenicity, and immunogenicity of the vaccines after the primary and boosting dose series. The primary endpoints of the study will investigate whether either vaccine or the combination of both produces the optimal immunological response.
If the world of aluminium intrigues you, to have a better purview of the ongoing activities in the industry go through AL Circle's special report, Global Aluminium Industry - Key Trends to 2030.
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