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)

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Abstract

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.

About the authors

A. B. Ryzhikov

State Scientific Center of Virology and Biotechnology “Vector” of Rospotrebnadzor

Author for correspondence.
Email: ryzhik@vector.nsc.ru

Aleksandr B. Ryzhikov - PhD (Biology), Head of the Department of Zoonotic Infections and Influenza.

630559, Novosibirsk Region, Koltsovo.

Phone: +7 (383) 363-47-00 (add. 27-62)

Fax: +7 (383) 336-74-09

Russian Federation

Е. А. Ryzhikov

LLC “EpiVac”

Email: e.a.ryzhikov@gmail.com

Director of LLC “EpiVac”.

Koltsovo, Novosibirsk Region.

Russian Federation

M. P. Bogryantseva

State Scientific Center of Virology and Biotechnology “Vector” of Rospotrebnadzor

Email: bogryantseva@vector.nsc.ru

PhD (Biology), Head of the Biological and Technology Supervision Department.

630559, Novosibirsk Region, Koltsovo.

Russian Federation

S. V. Usova

State Scientific Center of Virology and Biotechnology “Vector” of Rospotrebnadzor

Email: usova_sv@vector.nsc.ru

PhD (Medicine), Leading Researcher.

630559, Novosibirsk Region, Koltsovo.

Russian Federation

E. D. Danilenko

State Scientific Center of Virology and Biotechnology “Vector” of Rospotrebnadzor

Email: danilenko_ed@vector.nsc.ru

PhD (Biology), Director of the Medical Biotechnology Institute.

630559, Novosibirsk Region, Koltsovo.

Russian Federation

E. A. Nechaeva

State Scientific Center of Virology and Biotechnology “Vector” of Rospotrebnadzor

Email: nechaeva@vector.nsc.ru

PhD (Medicine), Deputy Director.

630559, Novosibirsk Region, Koltsovo.

Russian Federation

O. V. Pyankov

State Scientific Center of Virology and Biotechnology “Vector” of Rospotrebnadzor

Email: pyankov@vector.nsc.ru

PhD (Biology), Head of the Microorganisms Collection Department.

630559, Novosibirsk Region, Koltsovo.

Russian Federation

O. G. Pyankova

State Scientific Center of Virology and Biotechnology “Vector” of Rospotrebnadzor

Email: pyankova_og@vector.nsc.ru

Leading Researcher.

630559, Novosibirsk Region, Koltsovo.

Russian Federation

A. S. Gudymo

State Scientific Center of Virology and Biotechnology “Vector” of Rospotrebnadzor

Email: gudymo_as@vector.nsc.ru

Junior Researcher.

630559, Novosibirsk Region, Koltsovo.

Russian Federation

S. A. Bodnev

State Scientific Center of Virology and Biotechnology “Vector” of Rospotrebnadzor

Email: bodnev@vector.nsc.ru

PhD (Medicine), Leading Researcher.

630559, Novosibirsk Region, Koltsovo.

Russian Federation

G. S. Onkhonova

State Scientific Center of Virology and Biotechnology “Vector” of Rospotrebnadzor

Email: onhonova_gs@vector.nsc.ru

Junior Researcher.

630559, Novosibirsk Region, Koltsovo.

Russian Federation

E. S. Sleptsova

LLC “EpiVac”

Email: katyuss@yandex.ru

Head of the Quality Control Department.

Koltsovo, Novosibirsk Region.

Russian Federation

V. I. Kuzubov

Medical Unit No. 163 of the Federal Medical and Biological Agency of Russia

Email: msch163@fmbamail.ru

Head of the Medical Unit No. 163.

Koltsovo, Novosibirsk Region.

Russian Federation

N. N. Ryndyuk

Medical Unit No. 163 of the Federal Medical and Biological Agency of Russia

Email: help70@mail.ru

Deputy Head of the Medical Unit, Neurologist.

Koltsovo, Novosibirsk Region.

Russian Federation

Z. I. Ginko

Medical Unit No. 163 of the Federal Medical and Biological Agency of Russia

Email: ginko1948@mail.ru

Head of the Especially Dangerous Infections Facility, Plague Control Station, Infectologist.

Koltsovo, Novosibirsk Region.

Russian Federation

V. N. Petrov

State Scientific Center of Virology and Biotechnology “Vector” of Rospotrebnadzor

Email: vnpetrov@vector.nsc.ru

Head of the Information and Analytical Department.

630559, Novosibirsk Region, Koltsovo.

Russian Federation

A. A. Moiseeva

State Scientific Center of Virology and Biotechnology “Vector” of Rospotrebnadzor

Email: chalaya_aa@vector.nsc.ru

Junior Researcher.

630559, Novosibirsk Region, Koltsovo.

Russian Federation

P. Yu. Torzhkova

State Scientific Center of Virology and Biotechnology “Vector” of Rospotrebnadzor

Email: torzhkova_pyu@vector.nsc.ru

Researcher.

630559, Novosibirsk Region, Koltsovo.

Russian Federation

S. A. Pyankov

State Scientific Center of Virology and Biotechnology “Vector” of Rospotrebnadzor

Email: pyankov_sa@vector.nsc.ru

Leading Researcher.

630559, Novosibirsk Region, Koltsovo.

Russian Federation

T. V. Tregubchak

State Scientific Center of Virology and Biotechnology “Vector” of Rospotrebnadzor

Email: treg-@mail.ru

Leading Researcher.

630559, Novosibirsk Region, Koltsovo.

Russian Federation

D. V. Antonec

State Scientific Center of Virology and Biotechnology “Vector” of Rospotrebnadzor

Email: antonec@yandex.ru

PhD (Biology), Senior Researcher.

630559, Novosibirsk Region, Koltsovo.

Russian Federation

E. V. Gavrilova

State Scientific Center of Virology and Biotechnology “Vector” of Rospotrebnadzor

Email: gavrilova_ev@vector.nsc.ru

PhD (Biology), Deputy Director for Academic Affairs.

630559, Novosibirsk Region, Koltsovo.

Russian Federation

R. A. Maksyutov

State Scientific Center of Virology and Biotechnology “Vector” of Rospotrebnadzor

Email: maksyutov_ra@vector.nsc.ru

PhD, MD (Biology), Director General.

630559, Novosibirsk Region, Koltsovo.

Russian Federation

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

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