Evaluation of effectiveness of humoral immune response after vaccination with ‘CoviVaс’

Determining the efficiency of the principal means of specific immunoprophylaxis in forming thepost-vaccinal immunity against the new coronavirus infection (СOVID‑19) is a very important and topical problem. Solving it involves the evaluation of the efficiency and choosing the laboratory diagnostics technique for an adequate estimation of the nature and the level of thepost-vaccinal immune response (PIR).

Research objectives. Evaluating efficiency of the humoral PIR involving theproduction of specific antibodies in patients vaccinated with ‘CoviVac’using quantitative andsemi-quantitative test systems developed by Russian and international companies.

Material and methods. The level of antibodies matching the principal known antigens of the SARS-CoV‑2 virus was measured. The probes were taken in a group of 103 persons 22–30 days after vaccination. The techniques used were the principal immunochemical ones (enzymelinkedimmunosorbent assay (ELISA) and chemiluminescent microparticle immunoassay (CMIA)). The nature and the level of the PIR in terms of these antibodies’ production was studied, and the adequacy of the diagnostic techniques applied was evaluated, wherefore the result convergence was studied, and the techniques’ cross-sensitivity and specificity were determined.

Results. Insufficient level of PIR in terms of producing antibodies against SARS-CoV‑2 after vaccination with‘CoviVac’was established. The levels of antibodies were found to be not highenough to ensure a reliable immunity against the Covid‑19. However, a highdegree of correlation between the results of different quantitative techniques for measuring theantibodies matching the S-protein and its BRD of the SARS-CoV‑2 virus was determined. Arather high convergence of the results of the quantitative and semi-quantitative techniques usedfor studying this type of antibodies was found.

Conclusions. The PR upon the vaccination with the ‘CoviVac’ is characterized by insufficientintensity level in terms of forming the long-living IgG antibodies with surface antigens of SARS-CoV‑2. In particular, the antibody count, which is generally considered capable of ensuringreliable protection, was not reached. Efficiency of the immunochemical testsystems used in this study is high enough and can provide an adequate estimate of the PIR after the vaccination with ‘CoviVac’ .

1. Interim guidelines "Prevention, diagnosis and treatment of a new coronavirus infection (COVID-19)". Version 14 (12/27/2021). Moscow: Ministry of Health of the Russian Federation; 2021. 232 p.

2. Izvekov A.A., Kapto O.V., Khritinin D.F., et al. The use of reflexotherapy techniques in the treatment of transient post-vaccination reactions after immunization against COVID 19. Bulletinofneurology, psychiatryandneurosurgery.2021;(7):504–510. https://doi.org/10.33920/med 01–2107–02.

3. Ignatiev S.A., Alekseev I.B., Kazakov S.P., et al. Some Features of the Development of AMD and Other Diseases of the Posterior Pole Associated with the Virus Carrier and the Novel Coronavirus Disease COVID 19. International Journal of Clinical and Experimental Medical Sciences. 2021;7(5):127–137. https://doi.org/10.11648/j.ijcems.20210705.11

4. Logunov D.Y., Dolzhikova I.V., Zubkova O.V., et al. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID 19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia. Lancet. 2020;396(10255):887–897. https://doi.org/10.1016/S0140–6736(20)31866–3

5. Rossi A.H., Ojeda D. S., Varese A., et al. Sputnik V vaccine elicits seroconversion and neutralizing capacity to SARS-CoV 2 after a single dose. Cell Rep Med. 2021;2(8):100359. https://doi.org/10.1016/j.xcrm.2021.100359

6. Kozlovskaya L.I., Piniaeva A.N., Ignatyev G.M., et al. Long-term humoral immunogenicity, safety and protective efficacy of inactivated vaccine against COVID 19 (CoviVac) in preclinical studies. Emerg Microbes Infect. 2021;10(1):1790–1806. https://doi.org/10.108 0/22221751.2021.1971569

7. Tukhvatulin A.I., Dolzhikova I.V., Shcheblyakov D.V., et al. An open, non-randomised, phase 1/2 trial on the safety, tolerability, and immunogenicity of single-dose vaccine ‘‘Sputnik Light’’ for prevention of coronavirus infection in healthy adults. The Lancet Regional Health Europe. 2021;11:100241. https://doi.org/10.1016/j.lanepe.2021.100241

8. Interim guidelines "Procedure for vaccination of the adult population against COVID-19". M.: Ministry of Health of the Russian Federation, Federal State Budgetary Institution "NMITsTPM" of the Ministry of Health of Russia; 2021. 65 p

9. Shen C., Wang Z., Zhao F., et al. Treatment of 5 Critically Ill Patients WithCOVID 19 With Convalescent Plasma. JAMA. 2020;323(16):1582–1589. https://doi.org/10.1001/jama.2020.4783

10. Kazakov S. P., Alimbarova L. M., Chirkova E. Yu., et al. Study of the effectiveness of test systems based on the immunochemical method for the determination of specific antibodies of the JgM, IgG classes to SARS-CoV 2 coronavirus. Journal of Infectology. 2021;13(1 S1):53–54..

11. DomBourian M.G., Annen K., Huey L., Andersen G. Analysis of COVID 19 convalescent plasma for SARS-CoV 2 IgG using two commercial immunoassays.J Immunol Methods. 2020;486:112837. https://doi.org/10.1016/j.jim.2020.112837

12. Meschi S., Colavita F., Bordi L., et al. Performance evaluation of Abbott ARCHITECT SARSCoV 2 IgG immunoassay in comparison with indirect immunofluorescence and virus microneutralization test. J Clin Virol. 2020;129:104539. https://doi.org/10.1016/j.jcv.2020.104539

13. SARS-CoV 2 IgG II –kolichestvennyereagentydlya «Architect» (SARS-CoV 2 IgG II Quant Reagent Kit): instruktsiyadlya test-sistemykompanii «Abbott», December 2020.

14. Feng S., Phillips D.J., White T., et al. Correlates of protection against symptomatic and asymptomatic SARS-CoV 2 infection. Nat Med. 2021;27(11):2032–2040. https://doi. org/10.1038/s41591–021–01540–1

15. Komissarov A.A., Dolzhikova I.V., Efimov G.A., et al. Boosting of the SARS-CoV 2-specific immune response after vaccination with single-dose Sputnik Light vaccine. MedRxiv. 2021. https://doi.org/10.1101/2021.10.26.21265531

16. Xiao A.T., Gao C., Zhang S. Profile of specific antibodies to SARS-CoV 2: The firstreport. J Infect. 2020;81(1):147–178. https://doi.org/10.1016/j.jinf.2020.03.012

17. Ng D.L., Goldgof G.M., Shy B.R., et al. SARS-CoV 2 seroprevalence and neutralizing activity in donor and patient blood. Nat Commun. 2020;11(1):4698. https://doi.org/10.1038/ s41467–020–18468–8

18. Charlton C.L., Kanji J.N., Johal K., et al. Evaluation of Six Commercial Mid- to High-Volume Antibody and Six Point-of-Care Lateral Flow Assays for Detection of SARS-CoV 2 Antibodies. J ClinMicrobiol. 2020;58(10): e01361–20. https://doi.org/10.1128/JCM.01361–20

19. Okba N.M.A., Müller M. A., Li W., et al. Severe Acute Respiratory Syndrome Coronavirus 2-Specific Antibody Responses in Coronavirus Disease Patients. EmergInfectDis. 2020;26(7):1467–1488. https://doi.org/10.3201/eid2607.200841

20. Grzelak L., Temmam S., Planchais C., et al. A comparison of four serological assays for detecting anti-SARS-CoV 2 antibodies in human serum samples from different populations. SciTransl Med. 2020;12(559): eabc3103. https://doi.org/10.1126/scitranslmed.abc3103

21. Luchsinger L.L., Ransegnola B.P., Jin D.K., et al. Serological Assays Estimate Highly Variable SARS-CoV 2 Neutralizing Antibody Activity in Recovered COVID 19 Patients. J ClinMicrobiol. 2020;58(12): e02005–20. https://doi.org/10.1128/JCM.02005–20

22. Joyner M. J., Bruno K. A., Klassen S. A., et al. Safety Update: COVID 19 Convalescent Plasma in 20,000 Hospitalized Patients. Mayo Clin Proc. 2020;95(9):1888–1897. https://doi. org/10.1016/j.mayocp.2020.06.028

23. Khoury D.S., Cromer D., ReynaldiА., et al. Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV 2 infection. Nat Med. 2021;27(7):1205– 1211. https://doi.org/10.1038/s41591–021–01377–8

24. Muecksch F., Wise H., Batchelor B., et al. Longitudinal Serological Analysis and Neutralizing Antibody Levels in Coronavirus Disease 2019 Convalescent Patients. JInfectDis. 2021;223(3):389–398. https://doi.org/10.1093/infdis/jiaa659

25. van Kampen J.J.A., van de Vijver D.A.M.C., Fraaij P.L.A., et al. Duration and key determinants of infectious virus shedding in hospitalized patients with coronavirus disease 2019 (COVID 19). Nat Commun. 2021;12(1):267. https://doi.org/10.1038/s41467–020–20568–4

26. Dimeglio C., Herin F., Martin-Blondel G., et al. Antibody titers and protection against a SARSCoV 2 infection. J Infect. 2021 Sep 21: S0163–4453(21)00483–7. https://doi.org/10.1016/j. jinf.2021.09.013