Статья

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)

A. Ryzhikov, E. Ryzhikov, M. Bogryantseva, S. Usova, E. Danilenko, E. Nechaeva, O. Pyankov, O. Pyankova, A. Gudymo, S. Bodnev, G. Onkhonova, E. Sleptsova, V. Kuzubov, N. Ryndyuk, Z. Ginko, V. Petrov, A. Moiseeva, P. Torzhkova, S. Pyankov, T. Tregubchak, D. Antonec, E. Gavrilova, R. Maksyutov,
2021

Vaccination of the population is one of the most effective countermeasures in responding to the pandemic caused by novel coronavirus infection. Therefore, scientists all over the world have been working to develop effective and safe vaccines. We have developed a synthetic peptide vaccine, EpiVacCorona, against novel SARS-CoV-2 coronavirus, which is a suspension for intramuscular administration containing a composition of chemically synthesized peptide immunogens of the S protein of SARS-CoV-2 coronavirus conjugated to a carrier protein and adsorbed on aluminum hydroxide. Phase I–II clinical trials of the vaccine have started that consist of two stages: Stage 1 is an open study of the safety, reactogenicity, and immunological activity of the vaccine with the involvement of 14 volunteers aged 18–30 years; Stage 2 is a single blind, comparative, randomized placebo-controlled study with the involvement of 86 volunteers. The study involved volunteers aged 18–60 years; the vaccine was injected intramuscularly twice, spaced 21 days apart between injections. All local reactions in response to vaccine administration were mild, such as a short-term pain at the injection site. There were no signs of development of local or systemic adverse reactions. The two-dose vaccination scheme induced the production of antibodies, specific to the antigens that make up the vaccine, in 100% of the volunteers. Seroconversion with a neutralizing antibody titer ≥ 1:20 was reported in 100% of the volunteers 21 days following the second immunization dose. No seroconversion was reported in the groups of volunteers vaccinated with a placebo. The peptide-based EpiVacCorona Vaccine has low reactogenicity and is a safe, immunogenic product. Clinical Trials Identifier: NCT04527575.

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  • 1. Version of Record от 2021-01-01

Метаданные

Об авторах
  • A. Ryzhikov
    State Research Center of Virology and Biotechnology VECTOR
  • E. Ryzhikov
    LLC “EpiVac”
  • M. Bogryantseva
    State Research Center of Virology and Biotechnology VECTOR
  • S. Usova
    State Research Center of Virology and Biotechnology VECTOR
  • E. Danilenko
    State Research Center of Virology and Biotechnology VECTOR
  • E. Nechaeva
    State Research Center of Virology and Biotechnology VECTOR
  • O. Pyankov
    State Research Center of Virology and Biotechnology VECTOR
  • O. Pyankova
    State Research Center of Virology and Biotechnology VECTOR
  • A. Gudymo
    State Research Center of Virology and Biotechnology VECTOR
  • S. Bodnev
    State Research Center of Virology and Biotechnology VECTOR
  • G. Onkhonova
    State Research Center of Virology and Biotechnology VECTOR
  • E. Sleptsova
    LLC “EpiVac”
  • V. Kuzubov
    Medical and Sanitary Part № 163 of the Federal Medical and Biological Agency
  • N. Ryndyuk
    Medical and Sanitary Part № 163 of the Federal Medical and Biological Agency
  • Z. Ginko
    Medical and Sanitary Part № 163 of the Federal Medical and Biological Agency
  • V. Petrov
    State Research Center of Virology and Biotechnology VECTOR
  • A. Moiseeva
    State Research Center of Virology and Biotechnology VECTOR
  • P. Torzhkova
    State Research Center of Virology and Biotechnology VECTOR
  • S. Pyankov
    State Research Center of Virology and Biotechnology VECTOR
  • T. Tregubchak
    State Research Center of Virology and Biotechnology VECTOR
  • D. Antonec
    State Research Center of Virology and Biotechnology VECTOR
  • E. Gavrilova
    State Research Center of Virology and Biotechnology VECTOR
  • R. Maksyutov
    State Research Center of Virology and Biotechnology VECTOR
Название журнала
  • Russian Journal of Infection and Immunity
Том
  • 11
Выпуск
  • 1
Страницы
  • 283-296
Номер гранта
  • undefined
Тип документа
  • journal article
Тип лицензии Creative Commons
  • CC BY
Правовой статус документа
  • Свободная лицензия
Источник
  • scopus