It is composed of SARS-CoV-2
S1-RBD protein and synthetic peptides representing
T cell (
Th and
CTL) epitopes on the
nucleocapsid,
spike and
membrane proteins. The multitope composition is differentiated from other solely spike-protein based vaccines. By recognition against epitopes on Spike (S1-RBD and S2) and non-Spike (N and M) structure proteins, UB-612 provides
B-cell and T-cell memory immunity and offers a potential as a
universal vaccine to fend off the
Omicron variant and new emerging
variants of concern.[4][5] Vaxxinity began seeking regulatory approval for UB-612 for use as a booster vaccine in the United Kingdom and Australia in 2022.[6][7]
In September 2020, phase I clinical trials of UB-612 started in Taiwan.[8] and in January 2021, phase II clinical trials began in Taiwan.[9]
In February 2021, phase II/III clinical trials began.[10] Results from clinical trials showing positive safety and efficacy data were published in May 2022,[4] and in May-June 2023.[11][12]
In March 2022, Vaxxinity started an international phase III clinical trial of UB-612 as a heterologous booster vaccine against three approved platforms: mRNA, adenovirus vector, and inactivated virus.[13] The company announced positive topline data of the trial in December 2022[14] and positive results were published in January 2024.[15]
^Clinical trial number NCT04545749 for "A Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine" at
ClinicalTrials.gov
^Clinical trial number NCT04683224 for "A Study to Evaluate the Safety, Immunogenicity, and Efficacy of UB-612 COVID-19 Vaccine" at
ClinicalTrials.gov
^Clinical trial number NCT04773067 for "A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers" at
ClinicalTrials.gov
^Clinical trial number NCT05293665 for "Platform Trial to Compare Homologous Boost of Authorized COVID-19 Vaccines and Heterologous Boost With UB-612 Vaccine" at
ClinicalTrials.gov