It is composed of SARS-CoV-2S1-RBD protein and synthetic peptides representingT cell (Th andCTL) epitopes on thenucleocapsid,spike andmembrane 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 providesB-cell and T-cell memory immunity and offers a potential as auniversal vaccine to fend off theOmicron variant and new emergingvariants of concern.[5][6] Vaxxinity began seeking regulatory approval for UB-612 for use as a booster vaccine in the United Kingdom and Australia in 2022.[7][8]
In September 2020, phase I clinical trials of UB-612 started in Taiwan.[9] and in January 2021, phase II clinical trials began in Taiwan.[10]In February 2021, phase II/III clinical trials began.[11] Results from clinical trials showing positive safety and efficacy data were published in May 2022,[5] and in May-June 2023.[12][13]
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.[14] The company announced positive topline data of the trial in December 2022[15] and positive results were published in January 2024.[16] A Phase III international trial[17] conducted from March to September 2023, found that UB‑612, given as a heterologous third‑dose booster after primary vaccines, met non‑inferiority versus homologous boosters, outperformedChAdOx1 andSinopharm BIBP COVID-19 vaccines on neutralizing antibody responses (including Omicron subvariants), showed durability comparable toPfizer–BioNTech COVID-19 vaccine through 12 months, and had a similar safety profile.[18]
^Clinical trial numberNCT04545749 for "A Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine" atClinicalTrials.gov
^Clinical trial numberNCT04683224 for "A Study to Evaluate the Safety, Immunogenicity, and Efficacy of UB-612 COVID-19 Vaccine" atClinicalTrials.gov
^Clinical trial numberNCT04773067 for "A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers" atClinicalTrials.gov
^Clinical trial numberNCT05293665 for "Platform Trial to Compare Homologous Boost of Authorized COVID-19 Vaccines and Heterologous Boost With UB-612 Vaccine" atClinicalTrials.gov
^Clinical trial numberNCT05293665 for "Platform Trial to Compare Homologous Boost of Authorized COVID-19 Vaccines and Heterologous Boost With UB-612 Vaccine" atClinicalTrials.gov
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