Značilnosti cepiva EpiVacCorona (peptidno)

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UVOD

Cepivo EpiVacCorona je peptidno cepivo raziskovalnega centra Vector State Research Center of Virology and Biotechnology v Rusiji. Temelji na treh kemijsko sintetiziranih peptidih, ki predstavljajo epitope proteina bodice, ki jih prepoznavajo B-celice. Peptidi so kovalentno vezani na proteinski nosilec, cepivo pa poleg sintetiziranih peptidov in nosilnega proteina vsebuje še adjuvans aluminijev hidroksid.

KLINIČNE ŠTUDIJE

1. in 2. klinična faza sta potekali do oktobra 2020 v Rusiji, pri čemer je sodelovalo 100 prostovoljcev, starih med 18 in 60 let. Trenutno poteka 3. klinična faza, v katero je vključenih okoli 3000 ljudi, predvidoma pa naj bi trajala do avgusta 2021. Cepivo je že odobreno za uporabo v Rusiji in Turkmenistanu.

IZDELAVA CEPIVA

Peptide, ki so jih v nadaljevanju sintetizirali, so izbrali na podlagi znanih podatkov o 3D-strukturi in zaporedju, ki zapisuje za protein bodice. Pri tem so dobili tri ustrezne peptide, dolge med 20 in 31 aminokislinskih ostankov, ki so podobni epitopom virusnega proteina bodice, in jih prepoznavajo B-celice. Izbrane peptide so sintetizirali s standardnimi kemijskimi postopki za sintezo peptidov s trdno fazo. Tako pripravljene peptide so kovalentno vezali na proteinski nosilec, ki so ga pripravili v ekspresijskem sistemu E.coli. Proteinski nosilec predstavlja fuzijski protein, sestavljen iz proteina virusne nukleokapside in bakterijskega vezavnega proteina za maltozo (MBP). S tem so omogočili povečano stabilnost in imunogenost peptidov, mešanici peptidov in nosilnega proteina pa so na koncu dodali še adjuvans aluminijev hidroksid.

Pripravljeno cepivo vsebuje v eni dozi 260 ug aktivne učinkovine, administrira pa se v dveh dozah, ki se injicirata intramuskularno z 21 do 28-dnevnim zamikom med obema dozama. Cepivo se lahko shranjuje pri temperaturi hladilnika.

LITERATURA

[1] Ryzhikov AB, Ryzhikov EA, Bogryantseva MP, Gavrilova EV, Danilenko ED, Imatdinov IR, Maksyutov RA, Nechaeva EA, Popova AYu, Pyankov OV, Pyankova OG, Suloparov IM. Peptide immunogens and vaccine composition against COVID-19 coronavirus infection using peptide immunogens. Patent RU 2738081. 2020. (https://patentscope.wipo.int/search/en/detail.jsf?docId=RU313243384&tab=PCTDESCRIPTION)

[2] A. B. Ryzhikov et al., “A single blind, placebo-controlled randomized study of the safety, reactogenicity and immunogenicity of the ‘EpiVacCorona’ Vaccine for the prevention of COVID-19, in volunteers aged 18–60 years (phase I–II),” Russ. J. Infect. Immun., vol. 11, no. 2, pp. 283–296, 2021.

[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] EpiVacCorona – Wikipedia https://en.wikipedia.org/wiki/EpiVacCorona (pridobljeno 5. 5. 2021)

[5] EpiVacCorona Vaccine – precision vaccinations https://www.precisionvaccinations.com/vaccines/epivaccorona-vaccine (pridobljeno 4. 5. 2021)

[6] Study of the Safety, Reactogenicity and Immunogenicity of "EpiVacCorona" Vaccine for the Prevention of COVID-19 (EpiVacCorona) https://clinicaltrials.gov/ct2/show/NCT04527575 (pridobljeno: 4. 5. 2021)

[7] Study of the Tolerability, Safety, Immunogenicity and Preventive Efficacy of the EpiVacCorona Vaccine for the Prevention of COVID-19. https://www.clinicaltrials.gov/ct2/show/NCT04780035?id=NCT04780035&draw=2&rank=1&load=cart (pridobljeno: 4. 5. 2021)

[8] G. B. Fields “Introduction to peptide synthesis.” Current protocols in protein science vol. Chapter 18 (2002): Unit 18.1. doi:10.1002/0471140864.ps1801s26