Study on Immunogenicity, Reactogenicity and Safety of the VACΔ6 Vaccine in Volunteers Aged 18-60 Years

Summary

The Aim: Study immunogenicity, confirm the safety and tolerability of different schedules of vaccination with "live cell-based vaccine against smallpox and other orthopoxvirus infections (VAC∆6 vaccine) based on vaccinia virus" using a complex of clinical and laboratory-instrumental techniques. The research tasks are to: 1. To study the immunological activity of a single VAC∆6 vaccine dose of 1x10⁷ plaque-forming units (PFU). 2. To study the immunological activity of two VAC∆6 vaccine doses (given 28 days apart) of 1x10⁶ PFU. 3. Assess the safety of different VAC∆6 vaccination schedules using a set of clinical and laboratory-instrumental techniques (thermometry, measurement of blood pressure, heart and lung auscultation, ECG, common blood and urine tests, biochemical, immunological and virological studies). 4. Assess the reactogenicity of different VAC∆6 vaccination schedules (number of local and systemic reactions, the percentage of those vaccinated with systemic and local reactions of various severity degrees). 5. To identify VAC∆6 vaccine-associated adverse events. 6. Study cell-mediated immunity induced by different VAC∆6 vaccination schedules. 7. Determine the presence of the virus in specific skin formations (crusts, pustules), saliva, blood and urine. 8. Evaluate the protective efficacy of one and two doses of the studied VAC∆6 vaccine.

Timeline

Start

2021-10-01

Primary completion

2021-12-31

Completion

2022-04-01

Publications

• Background Yakubitskiy SN, Kolosova IV, Maksyutov RA, Shchelkunov SN. Attenuation of Vaccinia Virus. Acta Naturae. 2015 Oct-Dec;7(4):113-21.
• Background Maksyutov RA, Yakubitskyi SN, Kolosova IV, Shchelkunov SN. Comparing New-Generation Candidate Vaccines against Human Orthopoxvirus Infections. Acta Naturae. 2017 Apr-Jun;9(2):88-93.
• Background Olson VA, Shchelkunov SN. Are We Prepared in Case of a Possible Smallpox-Like Disease Emergence? Viruses. 2017 Aug 27;9(9):242. doi: 10.3390/v9090242.
• Background Shchelkunova GA, Shchelkunov SN. Smallpox, Monkeypox and Other Human Orthopoxvirus Infections. Viruses. 2022 Dec 29;15(1):103. doi: 10.3390/v15010103.
• Background Shchelkunova GA, Shchelkunov SN. 40 Years without Smallpox. Acta Naturae. 2017 Oct-Dec;9(4):4-12.
• Background Shchelkunov SN, Shchelkunova GA. Genes that Control Vaccinia Virus Immunogenicity. Acta Naturae. 2020 Jan-Mar;12(1):33-41. doi: 10.32607/actanaturae.10935.
• Background Shchelkunov SN, Shchelkunova GA. [We should be prepared to smallpox re-emergence.]. Vopr Virusol. 2019;64(5):206-214. doi: 10.36233/0507-4088-2019-64-5-206-214. Russian.
• Background Maksyutov RA, Yakubitskiy SN, Kolosova IV, Tregubchak TV, Shvalov AN, Gavrilova EV, Shchelkunov SN. Genome stability of the vaccine strain VACDelta6. Vavilovskii Zhurnal Genet Selektsii. 2022 Jul;26(4):394-401. doi: 10.18699/VJGB-22-48.
• Background Marennikova S.S., Shchelkunov S.N. Orthopoxviruses pathogenic for humans (monograph) // KMK Scientific Press Ltd., M. - 1998, - 386 p (in Russian).
• Background Kolosova I.V., Babkina I.N., Yakubitsky S.N., Maksyutov R.A., Safronov P.F., Shchelkunov S.N. Recombinant strain L-IVP 1421ABJCN of vaccinia virus with deleted virulence genes A56R, B8R, J2R, C3L, N1L to obtain a live cell-based attenuated vaccine against smallpox and other orthopoxviruses pathogenic to humans // RF Patent No. 2588388, priority 20.04.2015 (in Russian).
• Background Yakubitsky S.N., Kolosova I.V., Maksyutov R.A., Shchelkunov S.N. Recombinant strain VACΔ6 of vaccinia virus with deleted virulence genes C3L, N1L, J2R, A35R, A56R, B8R for obtaining a live cell-based attenuated vaccine against smallpox and other human orthopoxvirus infections // RF Patent No. 2621868, priority 24.06.2016 (in Russian).

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Indications