Biology:UB-612
| Vaccine description | |
|---|---|
| Target disease | SARS-CoV-2 |
| Type | peptide |
| Clinical data | |
| Routes of administration | Intramuscular |
| Identifiers | |
| DrugBank | |
UB-612 is a COVID-19 vaccine candidate developed by United Biomedical Asia (zh), 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
- ↑ 1.0 1.1 "Taiwan's second domestic COVID vaccine's midterm performance in phase II trials inferior to local competitor: experts". Taiwan News. 27 June 2021. https://www.taiwannews.com.tw/en/news/4233956.
- ↑ 2.0 2.1 "SARS-CoV-2 Vaccines Based on the Spike Glycoprotein and Implications of New Viral Variants". Frontiers in Immunology 12: 701501. 2021-07-12. doi:10.3389/fimmu.2021.701501. PMID 34322129.
- ↑ 3.0 3.1 "COVID-19 Vaccine" (in en-US). https://vaxxinity.com/covid-19-vaccine/.
- ↑ 4.0 4.1 "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). May 2022. doi:10.1172/JCI157707. PMID 35316221.
- ↑ "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. October 2022. doi:10.1093/infdis/jiac241. PMID 35723969.
- ↑ "Vaxxinity moves HQ, jobs to Florida's Space Coast from Texas". American City Business Journals. 9 February 2023. https://www.bizjournals.com/orlando/news/2023/02/09/vaxxinity-florida-space-coast-hq.html.
- ↑ "Phase 3 Trial of Vaxxinity's COVID-19 Vaccine as a Heterologous Booster Advances". 2 November 2022. https://www.contagionlive.com/view/phase-3-trial-of-vaxxinity-s-covid-19-vaccine-as-a-heterologous-booster-advances.
- ↑ 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
- ↑ "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. April 2023. doi:10.1371/journal.ppat.1010870. PMID 37079651.
- ↑ "Targeting Multiple Conserved T-Cell Epitopes for Protection against COVID-19 Moderate-Severe Disease by a Pan-Sarbecovirus Vaccine". June 2023. https://app.dimensions.ai/details/publication/pub.1160210192.
- ↑ 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". 5 December 2022. https://www.clinicaltrialsarena.com/news/vaxxinity-covid-booster-trial/.
External links
 |  |
