Preview

User

Not a user? Register with this site Forgot your password?

Epidemiology and Vaccinal Prevention

Advanced search

Preventive Efficacy of an Inactivated Whole-Virion Vaccine against Coronavirus infection in volunteers aged 18–60 years

https://doi.org/10.31631/2073-3046-2026-26-2-84-111

Abstract

Relevance. COVID-19 continues to be a significant burden on global healthcare. For aerosol-transmitted infections, including COVID19, vaccination is recognized as the most effective protective measure. The accumulation of an immune layer causes changes in the SARS-CoV-2 virion surface protein and its antigenic properties. The epidemiology of the infection, as well as preparation for future pandemics, require studies of the prophylactic properties of vaccines in the context of the circulation of antigenically distinct virus variants.

Aims. To study the prophylactic efficacy of an inactivated whole-virion vaccine for the prevention of coronavirus infection, prepared using the prototype B.1.1 strain, in the context of the circulation of a heterologous virus variant.

Materials and Methods. The prophylactic efficacy of the vaccine was studied in an open, non-comparative, multicenter prospective study involving volunteers aged 18–60 years for 6 months after the vaccination course (two doses/two doses + booster/three doses). The comparison group consisted of unvaccinated infected individuals from a large industrial city.

Results. Among fully vaccinated individuals, cases of COVID-19 were registered less frequently, and these cases were mostly mild (1.2 times more often), less often lasted more than 18 days (1.7 times less often), and less often led to hospitalization (not a single patient among the vaccinated was hospitalized). The prophylactic efficacy of the studied inactivated whole-virus vaccine against coronavirus infection was 51.1 % [95 % CI 46.0–56.8 %].

Conclusion. A full course of vaccination helps to reduce the number of COVID-19 cases, as well as the proportion of moderate and severe forms, as well as the proportion of patients with prolonged infection and the number of hospitalizations.

About the Authors

A. A. Siniugina
Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (Institute of Poliomyelitis)
Russian Federation

Aleksandra A. Siniugina – Cand. Sci. (Med.), Head of Quality and Innovation Development 

Moscow


I. V. Gordeychuk
Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (Institute of Poliomyelitis); Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation

Moscow


S. S. Andretsova
Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (Institute of Poliomyelitis)
Russian Federation

Svetlana S. Andretsova – Junior researcher at the Laboratory for Modeling Immunobiological Processes with the Experimental Clinic of Igruncov Monkeys 

Moscow


N. V. Yagovkina
Federal State Budgetary Educational Institution of Higher Education «Kirov State Medical University» of the Ministry of Healthcare of the Russian Federation
Russian Federation

Nadezhda V. Yagovkina – Cand. Sci. (Med.), Associate Professor of the Department of Obstetrics and Gynecology

Kirov


A. G. Obrezan
Limited Liability Company «My Medical Center» (MMC LLC)
Russian Federation

Andrei G. Obrezan – Dr. Sci. (Med.), Professor, Chief Doctor 

St. Petersburg


A. G. Chuchalin
State Budgetary Healthcare Institution of the city of Moscow «D.D. Pletnev City Clinical Hospital of the Department of Health of the City of Moscow» (GBUZ «GKB named after D.D. Pletnev DZM»)
Russian Federation

Aleksandr G. Chuchalin – the RAS Academician, Dr. Sci. (Med), consultant of the Department of Intensive Care and Intensive care Unit 

Moscow


M. P. Kostinov
Federal State Budgetary Scientific Institution «I.I. Mechnikov Vaccine and Serum Research Institute»; Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation

Mikhail P. Kostinov – the RAS Corresponding Member, Dr. Sci. (Med), Professor, Honored Scientist of the Russian Federation, Head of the Laboratory of the I.I. Mechnikov Federal State Budgetary Scientific Research Institute; Head of the Department of Epidemiology and Modern Vaccination Technologies, Sechenov First Moscow State Medical (Sechenovskiy University)

Moscow


V. V. Popov
Private healthcare institution «Clinical Hospital «RZD-Medicine named after N.A. Semashko» (CHUZ KB RZD-Medicine named after Semashko)
Russian Federation

Vladimir V. Popov – Dr. Sci. (Med), Professor, doctor of clinical Pharmacology

Moscow


I. V. Feldblum
The Federal State Budgetary Scientific Institution «Izmerov Research Institute of Occupational Health»; Federal State Budgetary Educational Institution of Higher Education «Perm State Medical University named after Academician E.A.Wagner» of the Ministry of Health of the Russian Federation
Russian Federation

Irina V. Feldblum –Dr. Sci. (Med), Professor, Leading Researcher at the Federal State Budgetary Budgetary Institution «Scientific Research Institute of MT», Moscow; Federal State Budgetary Educational Institution of Higher Education «Perm State Medical University named after Academician E.A. Wagner» of the Ministry of Health of the Russian Federation

Moscow, Perm


U. M. Tomaev
The State Budgetary healthcare Institution of the Moscow region «Elektrostal Central City Hospital»
Russian Federation

Uruzmag M. Tomaev – allergist-immunologist 

Moscow region


A. N. Galustyan
Limited Liability Company «Medical Technologies» (LLC «Medical Technologies»); State Budgetary Institution of Higher Professional Education «Saint-Petersburg state pediatric Medical University» Head of the Department of Pharmacology with the course of clinical pharmacology and pharmacoeconomics
Russian Federation

Anna N. Galustyan – Cand. Sci. (Med.), Chief Physician of Medical Technologies LLC

St. Petersburg


N. N. Ryndyuk
Federal State Budgetary Healthcare Institution Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency of Russia
Russian Federation

Natalia N. Ryndyuk – Neurologist, deputy chief of medical department 

Novosibirsk


A. K. Korduban
Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (Institute of Poliomyelitis)
Russian Federation

Anastasia K. Korduban – Head of Clinical Trials team

Moscow


A. A. Kovpak
Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (Institute of Poliomyelitis)
Russian Federation

Anastasia A. Kovpak – Head of the group of purification processes and formulation of finished dosage forms

Moscow


G. A. Malkin
Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (Institute of Poliomyelitis)
Russian Federation

Gennady A. Malkin – Deputy Head of the Department for Development and Implementation of Innovative and Semi-Industrial Technologies

Moscow


A. N. Piniaeva
Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (Institute of Poliomyelitis)
Russian Federation

Anastasia N. Piniaeva – Cand. Sci. (Biol.), Chief technology Officer 

Moscow


Yu. Yu. Ivin
Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (Institute of Poliomyelitis)
Russian Federation

Yury Yu. Ivin, Cand. Sci. (Biol.), Head of the Department for Development and Implementation of Innovative and SemiIndustrial Technologies

8, building 1, Poliomyelitis Institute settlement, internal territorial city, Filimonkovsky municipal district, Moscow, 108819


E. A. Korduban
Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (Institute of Poliomyelitis)
Russian Federation

Ekaterina A. Korduban – Head of Regulatory Affairs and Sales

Moscow


A. A. Ishmukhametov
Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (Institute of Poliomyelitis); Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation

Aydar A. Ishmukhametov – the RAS Academician, Dr. Sci. (Med), professor, General manager Chumakov FSC R&D IBP RAS (Institute of Poliomyelitis)

Moscow


References

1. Pylaeva SK, Sinyugina AA, Kozlovskaya LI, et al. Neutralising and non-neutralising antibodies to SARS-CoV-2: role during infection and in the evolution of antigenic structure. Epidemiology and Vaccinal Prevention. 2024;23(6):169–176 (In Russ.). https://doi:10.31631/2073-3046-2024-23-6-169-176

2. Logunov D.Y., Dolzhikova I.V., Shcheblyakov D.V., et al. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: An interim analysis of a randomised controlled phase 3 trial in Russia. Lancet 2021, 397, 671–681.

3. Nextstrain. Available at: https://nextstrain.org/ncov/gisaid/global/all-time

4. Perlman S, Masters PS. Coronaviridae: The Viruses and Their Replication in Fields Virology: Emerging Viruses, 7th Ed., Eds. Howley PM, Knipe DM, Whelan S, Wolters Kluwer, 2020:410–448.

5. Drapkina O. M., Gorshkov A. Yu. Procedure for vaccination against a new coronavirus infection (COVID-19). Temporary methodological recommendations / M. – 2022.

6. Kozlovskaya LI, Piniaeva AN, Ignatyev GM, et al. Long-term humoral immunogenicity, safety and protective efficacy of inactivated vaccine against COVID-19 (CoviVac) in preclinical studies. Emerg Microbes Infect. 2021 Dec;10(1):1790–1806. doi: 10.1080/22221751.2021.1971569.

7. Available at: https://www.rospotrebnadzor.ru/

8. Antonelli M., Penfold RS, Merino J, et al. Risk factors and disease profile of post-vaccination SARS-CoV-2 infection in UK users of the COVID Symptom Study app: a prospective, community-based, nested, case-control study. Lancet Infect Dis. 2022 Jan;22(1):43–55. doi: 10.1016/S1473-3099(21)00460-6.

9. Linets YuP, Artyukhov SV, Kazantsev AN, et al. COVID-19 Course In Vaccinated Patients. Sklifosovsky Journal of Emergency Medical Care. 2021;10(4):636–641. https://doi.org/10.23934/2223-9022-2021-10-4-636-641

10. Ozdemir Y. E., Kizilcay B, Sonmezisik M, et al. Evaluation of clinical outcomes of vaccinated and unvaccinated patients with hospitalization for COVID-19. Acta Microbiol Immunol Hung. 2022 Sep 21;69(4):270–276. doi: 10.1556/030.2022.01860. Print 2022 Dec 6.

11. Kostinov MP, Zhang Chen, Khrapunova IA, et al. Rationale for vaccination against COVID-19 among elderly and senile people with comorbid conditions. Epidemiology and Vaccinal Prevention. 2023;22(6):133–138 (In Russ.). https://doi:10.31631/2073-3046-2023-22-6-133-138

12. Fatima S, Zafar A, Afzal H. et al. (2022) COVID-19 infection among vaccinated and unvaccinated: Does it make any difference? PLoS ONE 17(7): e0270485. https://doi.org/10.1371/journal.pone.0270485


Review

For citations:

Siniugina A.A., Gordeychuk I.V., Andretsova S.S., Yagovkina N.V., Obrezan A.G., Chuchalin A.G., Kostinov M.P., Popov V.V., Feldblum I.V., Tomaev U.M., Galustyan A.N., Ryndyuk N.N., Korduban A.K., Kovpak A.A., Malkin G.A., Piniaeva A.N., Ivin Yu.Yu., Korduban E.A., Ishmukhametov A.A. Preventive Efficacy of an Inactivated Whole-Virion Vaccine against Coronavirus infection in volunteers aged 18–60 years. Epidemiology and Vaccinal Prevention. 2026;25(2):84-111. (In Russ.) https://doi.org/10.31631/2073-3046-2026-26-2-84-111

Views: 301

JATS XML


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2073-3046 (Print)
ISSN 2619-0494 (Online)

Editorial of the journal журнала «Epidemiology and Vaccinal Prevention»
Verkhnyaya Krasnoselskaya 10, office 57. Moscow, Russia 107140
E-mail: epidemvac@yandex.ru

Processing of personal data
supported by NEICON (Elpub lab)