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UB-612
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UB-612
Vaccine description
TargetSARS-CoV-2
Vaccine typePeptide subunit
Clinical data
Routes of
administration
Intramuscular
Identifiers
CAS Number
DrugBank

UB-612 is a COVID-19 vaccine candidate developed by United Biomedical Asia [zh], and Vaxxinity, Inc.[2] It is a peptide vaccine.[3][4]

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.[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]

Technology

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UB-612 is a peptide vaccine incorporating multiple epitopes, including the spike protein receptor binding domain as well as other virus structural proteins.[2][4] The spike protein peptide is fused to an Fc domain of single-chain IgG1, and the other six peptides are derived from highly conserved sequences from the spike, nucleocapsid, and membrane proteins of SARS-CoV-1 and SARS-CoV-2. It also contains a proprietary UBITh1 peptide derived from the measles virus fusion protein, CpG oligonucleotides, and aluminum phosphate adjuvant to improve the immune response. It is produced in CHO cells.[3]

Clinical trials

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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, outperformed ChAdOx1 and Sinopharm BIBP COVID-19 vaccines on neutralizing antibody responses (including Omicron subvariants), showed durability comparable to Pfizer–BioNTech COVID-19 vaccine through 12 months, and had a similar safety profile.[18]

References

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