The trial enrolled a total of 944 subjects aged 16 years and above at seven centres in the US, Panama, and the Philippines.
Individuals previously inoculated with three vaccine platforms which are authorised worldwide, namely Pfizer-BioNTech’s BNT162b2, AstraZeneca’s ChAdOx1-S, and Sinopharm’s BIBP, were part of the trial.
The randomised, global, active-controlled platform trial is designed to analyse the safety and immunogenicity of the UB-612 booster against the other three vaccines administered as homologous boosters.
Safety, tolerability, and live virus-neutralising antibody titers against the SARS-CoV-2 virus’ Wuhan strain at day 29 are the trial’s primary endpoints.
Neutralising antibody titers against the Omicron variant, as well as seroconversion rates at day 29 and kinetics of neutralising and RBD binding IgG antibody responses till one year, comprise the secondary immunogenicity endpoints of the trial.
According to positive topline data from the pivotal, international trial, the vaccine given as a single heterologous booster dose induced robust neutralising antibodies against Covid-19 versus the three authorised platform vaccines given as homologous boosters.
The initial safety findings showed that the UB-612 vaccine was generally well tolerated, without any serious adverse events occurring.
Anticipated to conclude in the second half of next year, the study is underway to evaluate the long-term safety profile of the vaccine.
A multitope subunit protein/peptide-based Covid-19 vaccine candidate, UB-612 can induce the immune system’s B- and T-cell arms.
Vaxxinity CEO Mei Mei Hu said: “Given these Phase III topline results, and UB-612’s generally lower cost structure and ease of distribution, we believe UB-612 has the potential to serve as an optimal choice for boosting, especially in developing countries, as Covid-19 enters an endemic stage.”
The company plans to conclude rolling submissions with the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the Australian Therapeutic Goods Administration (TGA) to obtain conditional and provisional marketing authorisations, respectively, for the UB-612 vaccine in the first half of next year.
In October this year, Vaxxinity completed enrolment of subjects in the Phase III trial of UB-612 as a heterologous booster.