Vaxxinity has concluded subject enrolment in its Phase III pivotal clinical trial of Covid-19 vaccine, UB-612, as a heterologous booster.
UB-612 is being analysed as a booster following an initial regimen with messenger ribonucleic acid (mRNA), adeno-vectored, and inactivated vaccines.
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The international trial will assess the safety and immunogenicity of the UB-612 booster in subjects who have received mRNA, adenovirus vector, or inactivated virus vaccines as an initial regimen, versus a booster dose with the shot used in the initial series.
Vaxxinity commenced a rolling submission to the Australian Therapeutic Goods Administration (TGA) seeking provisional approval for UB-612 as a heterologous booster.
In September this year, the regulatory agency granted provisional determination.
The company anticipates reporting topline findings from the trial in the fourth quarter of this year.
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By GlobalDataA multitope subunit protein/peptide-based Covid-19 vaccine candidate, UB-612 could activate the immune system’s B- and T-cell arms.
It is created to enhance immunity against Covid-19 in individuals aged 16 years or above.
Vaxxinity CEO Mei Mei Hu said: “We look forward to announcing topline immunogenicity data that will serve as the basis for future authorisation applications.
“Our regulatory progress continues with the initiation of a rolling submission to the TGA in Australia, following the previously announced initiation of the rolling submission to MHRA in the UK.
“The review and potential approval by these two regulatory agencies will allow us to pursue our mission of democratising health by bringing UB-612 to the countries that are most in need of next generation Covid-19 vaccines.”
In March this year, the company commenced participant dosing in a Phase III trial of UB-612.
Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.
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