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UVOD

VBI Vaccines Inc. je biofarmacevtsko podjetje, ki ga poganja imunologija in si prizadeva za močno preprečevanje in zdravljenje bolezni. S svojim inovativnim pristopom k virusom podobnim delcem ("VLP"), vključno s tehnologijo platforme VLP ("eVLP"), VBI razvija kandidate za cepiva, ki posnemajo naravno predstavitev virusov, namenjene izvabljanju prirojene moči človeškega imunskega sistema.

KAJ JE VBI-2902a CEPIVO

VBI-2902a je kandidat za preskusno cepivo, ki uporablja ekspresijo virusnih podobnih delcev modificirano verzijo glikoproteina spike SARS-CoV-2 in je zasnovan tako, da inducira nevtralizirajoča protitelesa in imunski odziv, ki ga povzročajo celice, proti SARS-CoV-2 spike proteinu. VBI-2902a z vsebnostjo do 10 μg proteinov in dodatkom aluminijevega fosfata se daje z intramuskularno injekcijo.

KLINIČNE ŠTUDIJE

Študija faze 1/2 bo ovrednotila varnost, prenašanje in imunogenost zdravila VBI-2902a v režimu enega in dveh odmerkov ter dve ravni odmerka (5 μg in 10 μg spike proteina) v primerjavi s placebom (fiziološka raztopina) pri zdravih odrasli, stari 18 let ali več. Število udeležencev je 780.

Začetna študija faze 1/2 VBI-2902a, se je začela 15. marca 2021 in naj bi bila končana junija 2022.

LITERATURA

[1] Jeff Baxter, CEO; David E. Anderson, CSO Preclinical Coronavirus Program Data (https://1o976r1jw2eculmeoxz46ig6-wpengine.netdna-ssl.com/wp-content/uploads/2020/08/August-2020-VBI-2900-Preclinical-Data-Announcement_Final.pdf)

[2] View ORCID ProfileAnne-Catherine Fluckiger, View ORCID ProfileBarthelemy Ontsouka, Jasminka Bozic, Abebaw Diress, Tanvir Ahmed, Tamara Berthoud, Anh Tran, Diane Duque, Mingmin Liao, Michael McCluskie, View ORCID ProfileFrancisco Diaz-Mitoma, David E. Anderson, Catalina Soare, “An enveloped virus-like particle vaccine expressing a stabilized prefusion form of the SARS-CoV-2 spike protein elicits potent immunity after a single dose” bioRxiv, 28.4.2021 (https://www.biorxiv.org/content/10.1101/2021.04.28.441832v1.full)

[3] A. B. Ryzhikov et al., “Immunogenicity and protectivity of the peptide candidate vaccine against SARS-CoV-2,” Ann. Russ. Acad. Med. Sci., vol. 76, no. 1, pp. 5–19, 2021.

[4] VBI-2902 – Wikipedia https://en.wikipedia.org/wiki/VBI-2902 (pridobljeno 5. 5. 2021)

[5] VBIVACCINE – VBI Vaccines Announces Publication of Preclinical and Challenge Study Data of its eVLP Vaccine Candidate Against COVID-19 (VBI-2902) April 28, 2021 https://www.vbivaccines.com/press-releases/vbi-2902-preclinical-and-challenge-study-data/ (pridobljeno 6. 5. 2021)

[6] VBIVACCINE - VBI Vaccines Announces Preclinical Coronavirus Program Data and Selection of Clinical Candidates with Potential as One-Dose Vaccines https://www.vbivaccines.com/press-releases/preclinical-coronavirus-data-candidate-selection/ (pridobljeno: 7. 5. 2021)

[7] VBI-2902a - ClinicalTrials.gov, Safety, Tolerability, and Immunogenicity of the COVID-19 Vaccine Candidate (VBI-2902a) https://clinicaltrials.gov/ct2/show/NCT04773665 (pridobljeno: 7. 5. 2021)