FIELD: biotechnology.
SUBSTANCE: what is described is a pharmaceutical composition for inducing a specific immune response against the acute respiratory syndrome virus SARS-CoV-2, containing the nucleocapsid protein SARS-CoV-2. Vaccine has the following composition per 1 ml: nucleocapsid protein NSARS-CoV-2, having the amino acid sequence SEQ ID NO: 1 20–100 mcg; squalane 15–40 mg; α-tocopherol 5–15 mg; polysorbate 80 1–10 mg; disodium phosphate 0.1–2.0 mg; monopotassium phosphate 0.01–0.25 mg; potassium chloride 0.01–0.2 mg; sodium chloride 0.1–8.5 mg; water for injections up to 1 ml. Also disclosed is a method of producing said composition, which involves: providing a nucleocapsid protein NSARS-CoV-2, having the amino acid sequence SEQ ID NO: 1, in amount of 20 to 100 mcg/ml; dissolving the protein in the aqueous solvent and bringing the protein N content in the solution to the required concentration; preparation of an aqueous solution of an adjuvant; mixing an aqueous solution containing protein N and an aqueous solution of an adjuvant; homogenizing the obtained mixture until a color-uniform solution is obtained; adjusting the pH of the obtained composition to 7.2–7.6.
EFFECT: invention enables to obtain a stable composition which, when introduced into the body, can induce an immune response and induce a specific immune response against SARS-CoV-2.
10 cl, 3 dwg, 8 tbl, 7 ex
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Authors
Dates
2022-03-14—Published
2021-08-05—Filed