UB-612

UB-612
Vaccine description
Target	SARS-CoV-2
Vaccine type	Peptide subunit
Clinical data
Routes of; administration	Intramuscular
Identifiers
DrugBank	DB16444;

UB-612 is a COVID-19 vaccine candidate developed by United Biomedical Asia, and Vaxxinity, Inc.[1] It is a peptide vaccine.[2][3]

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]

Technology

UB-612 is a peptide vaccine incorporating multiple epitopes, including the spike protein receptor binding domain as well as other virus structural proteins.[1][3] 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.[2]

Clinical trials

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]

References

Liao G (27 June 2021). "Taiwan's second domestic COVID vaccine's midterm performance in phase II trials inferior to local competitor: experts". Taiwan News. Retrieved 8 July 2021.
Martínez-Flores D, Zepeda-Cervantes J, Cruz-Reséndiz A, Aguirre-Sampieri S, Sampieri A, Vaca L (12 July 2021). "SARS-CoV-2 Vaccines Based on the Spike Glycoprotein and Implications of New Viral Variants". Frontiers in Immunology. 12: 701501. doi:10.3389/fimmu.2021.701501. PMC 8311925. PMID 34322129.
"COVID-19 Vaccine". Vaxxinity. Archived from the original on 9 October 2021. Retrieved 9 October 2021.
Wang CY, Hwang KP, Kuo HK, Peng WJ, Shen YH, Kuo BS, et al. (May 2022). "A multitope SARS-CoV-2 vaccine provides long-lasting B cell and T cell immunity against Delta and Omicron variants". The Journal of Clinical Investigation. 132 (10). doi:10.1172/JCI157707. PMC 9106357. PMID 35316221.
Guirakhoo F, Wang S, Wang CY, Kuo HK, Peng WJ, Liu H, et al. (October 2022). "High Neutralizing Antibody Levels Against Severe Acute Respiratory Syndrome Coronavirus 2 Omicron BA.1 and BA.2 After UB-612 Vaccine Booster". The Journal of Infectious Diseases. 226 (8): 1401–1406. doi:10.1093/infdis/jiac241. PMC 9278180. PMID 35723969.
Lynch R (9 February 2023). "Vaxxinity moves HQ, jobs to Florida's Space Coast from Texas". Orlando Business Journal. American City Business Journals. Retrieved 26 February 2023.
Lorenz J (2 November 2022). "Phase 3 Trial of Vaxxinity's COVID-19 Vaccine as a Heterologous Booster Advances". ContagionLive. Retrieved 26 February 2023.
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
Wang CY, Peng WJ, Kuo BS, Ho YH, Wang MS, Yang YT, et al. (April 2023). Krammer F (ed.). "Toward a pan-SARS-CoV-2 vaccine targeting conserved epitopes on spike and non-spike proteins for potent, broad and durable immune responses". PLOS Pathogens. 19 (4): e1010870. doi:10.1371/journal.ppat.1010870. PMC 10153712. PMID 37079651.
"Targeting Multiple Conserved T-Cell Epitopes for Protection against COVID-19 Moderate-Severe Disease by a Pan-Sarbecovirus Vaccine". June 2023.
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
"Vaxxinity's Phase III Covid-19 booster trial meets endpoints". Clinical Trials Arena. 5 December 2022. Retrieved 25 February 2023.

External links

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[:0-1] Liao G (27 June 2021). "Taiwan's second domestic COVID vaccine's midterm performance in phase II trials inferior to local competitor: experts". Taiwan News. Retrieved 8 July 2021.

[:1-2] Martínez-Flores D, Zepeda-Cervantes J, Cruz-Reséndiz A, Aguirre-Sampieri S, Sampieri A, Vaca L (12 July 2021). "SARS-CoV-2 Vaccines Based on the Spike Glycoprotein and Implications of New Viral Variants". Frontiers in Immunology. 12: 701501. doi:10.3389/fimmu.2021.701501. PMC 8311925. PMID 34322129.

[:2-3] "COVID-19 Vaccine". Vaxxinity. Archived from the original on 9 October 2021. Retrieved 9 October 2021.

[Wang_2022-4] Wang CY, Hwang KP, Kuo HK, Peng WJ, Shen YH, Kuo BS, et al. (May 2022). "A multitope SARS-CoV-2 vaccine provides long-lasting B cell and T cell immunity against Delta and Omicron variants". The Journal of Clinical Investigation. 132 (10). doi:10.1172/JCI157707. PMC 9106357. PMID 35316221.

[Guirakhoo_2022-5] Guirakhoo F, Wang S, Wang CY, Kuo HK, Peng WJ, Liu H, et al. (October 2022). "High Neutralizing Antibody Levels Against Severe Acute Respiratory Syndrome Coronavirus 2 Omicron BA.1 and BA.2 After UB-612 Vaccine Booster". The Journal of Infectious Diseases. 226 (8): 1401–1406. doi:10.1093/infdis/jiac241. PMC 9278180. PMID 35723969.

[Lynch_2023-6] Lynch R (9 February 2023). "Vaxxinity moves HQ, jobs to Florida's Space Coast from Texas". Orlando Business Journal. American City Business Journals. Retrieved 26 February 2023.

[Lorenz_2022-7] Lorenz J (2 November 2022). "Phase 3 Trial of Vaxxinity's COVID-19 Vaccine as a Heterologous Booster Advances". ContagionLive. Retrieved 26 February 2023.

[8] Clinical trial number NCT04545749 for "A Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine" at ClinicalTrials.gov

[9] Clinical trial number NCT04683224 for "A Study to Evaluate the Safety, Immunogenicity, and Efficacy of UB-612 COVID-19 Vaccine" at ClinicalTrials.gov

[10] Clinical trial number NCT04773067 for "A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers" at ClinicalTrials.gov

[11] Wang CY, Peng WJ, Kuo BS, Ho YH, Wang MS, Yang YT, et al. (April 2023). Krammer F (ed.). "Toward a pan-SARS-CoV-2 vaccine targeting conserved epitopes on spike and non-spike proteins for potent, broad and durable immune responses". PLOS Pathogens. 19 (4): e1010870. doi:10.1371/journal.ppat.1010870. PMC 10153712. PMID 37079651.

[12] "Targeting Multiple Conserved T-Cell Epitopes for Protection against COVID-19 Moderate-Severe Disease by a Pan-Sarbecovirus Vaccine". June 2023.

[13] 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

[CTA_2022-14] "Vaxxinity's Phase III Covid-19 booster trial meets endpoints". Clinical Trials Arena. 5 December 2022. Retrieved 25 February 2023.