Vaxxinity has commenced dosing of subjects in a Phase III pivotal clinical trial of its next-generation Covid-19 booster vaccine candidate, UB-612.
The trial has enrolled and dosed subjects at the PanAmerican Clinical Research trial site in Brownsville, Texas, US. The company plans to report topline data from the trial in the second half of this year.
A first multitope subunit protein/peptide-based vaccine candidate for Covid-19, UB-612 can potentially activate the immune system’s B and T-cell arms.
The multicentre, active-controlled, randomised, head-to-head global platform heterologous booster trial will assess UB-612’s potential in boosting immunity against Covid-19 in individuals fully vaccinated with any of the three comparator vaccines.
Pfizer-BioNTech’s mRNA vaccine BNT162b2, AstraZeneca’s adenovirus vector vaccine, ChAdOx1-S and Sinopharm’s inactivated virus Covid-19 vaccine are the three comparator vaccines.
The trial will enrol subjects aged 16 years above who have received the initial two-dose vaccine series with an authorised comparator vaccine.
Determining non-inferiority of heterologous boosting with a single dose of UB-612 versus three comparator Covid-19 shots is the primary objective of the trial.
Furthermore, neutralising antibodies against Omicron and other variants of the virus, non-neutralising functional antibodies and T cell responses will be assessed as secondary and exploratory objectives.
It has entered an agreement with various regulatory agencies globally on trial design and data package needed for obtaining authorisation for the vaccine.
On obtaining positive data from the Phase III trial, the company may seek conditional approval for UB-612.
In Phase I and II trials, UB-612 was demonstrated to be well-tolerated without any substantial safety issues.
Vaxxinity CEO Mei Mei Hu said: “We are excited at the prospects for UB-612 to meet this challenge, having demonstrated UB-612 safety and tolerability in subjects receiving two and three doses of the vaccine candidate and that when used as a homologous booster, UB-612 elicits neutralising antibodies against multiple variants, including the Omicron variant at similar or greater titers than those reported by an approved mRNA vaccine booster.”
In June last year, Vaxxinity and Aurobindo Pharma sought approval from the Drugs Controller General of India to conduct Phase II/III trials of UB-612 in the country.