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]
In June 2021, a report revealed that the UB-612 vaccine was developed in part by the US-based Covaxx, a for-profit venture initiated by Blackwater founderErik Prince. In a series of text messages to Paul Behrends, the close associate recruited for the Covaxx project, Prince described the profit-making possibilities of selling the COVID-19 vaccines. At the time, Covaxx had not yet provided any data from the clinical trials on safety or efficacy it conducted in Taiwan. The responsibility of creating distribution networks was assigned to an Abu Dhabi-based entity, which was mentioned as "Windward Capital" on the Covaxx letterhead but was actually Windward Holdings. The firm's sole shareholder, who handled "professional, scientific and technical activities", was Erik Prince. In March 2021, Covaxx raised $1.35 billion in a private placement.[19]
^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
^Wang CY, Kuo BS, Lee YH, Ho YH, Pan YH, Yang YT, et al. (June 2023). "Targeting Multiple Conserved T-Cell Epitopes for Protection against COVID-19 Moderate-Severe Disease by a Pan-Sarbecovirus Vaccine".medRxiv10.1101/2023.06.28.23291948.
^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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