Search

RU-2025122879-A - mRNA and recombinant protein vaccines against infection caused by SARS-COV-2 or its variants and their uses

RU2025122879ARU 2025122879 ARU2025122879 ARU 2025122879ARU-2025122879-A

Inventors

  • ВЭЙ, Сявэй
  • ЧЖАО, Чживэй
  • ЯН, Цзиньлян
  • ЛУ, Гуанвэнь
  • ЧЭН, Пин
  • Ян, Ли
  • ЛИ, Цзюн
  • ЯН, Цзинюнь
  • ВАН, Вэй
  • Вэй, Юйцюань
  • ВАН, Чжэньлин

Assignees

  • ВестВак Биофарма Ко., Лтд.

Dates

Publication Date
20260507
Application Date
20231221
Priority Date
20230120

Claims (18)

  1. 1. An mRNA vaccine for the prevention and/or treatment of infections caused by SARS-CoV-2 or a mutant thereof, characterized in that it includes an mRNA vaccine against infections caused by a mutant SARS-CoV-2 as an active ingredient.
  2. 2. A recombinant protein-based vaccine for the prevention and/or treatment of infection caused by SARS-CoV-2 or its variant, characterized in that it includes a recombinant protein-based vaccine as an active component against infection caused by SARS-CoV-2 variants.
  3. 3. The mRNA vaccine of claim 1, wherein the mRNA sequence comprises a full-length nucleic acid sequence encoding the S protein of the SARS-CoV-2 variants.
  4. 4. The mRNA vaccine according to claim 1, wherein the full-length nucleic acid sequence encoding the S protein of the SARS-CoV-2 variants is shown in the sequence of SEQ ID NO: 1 and/or SEQ ID NO: 2, or is a variant that exhibits homology and the same or similar biological activity with the sequence of SEQ ID NO: 1 and/or SEQ ID NO: 2, and is obtained by substitution and/or deletion and/or insertion of at least one amino acid in the sequence of SEQ ID NO: 1 and/or SEQ ID NO: 2; preferably, the sequence variant is a variant obtained by substitution and/or deletion and/or insertion of 1-400 amino acids in the sequence of SEQ ID NO: 1 and/or SEQ ID NO: 2; and preferably, the sequence variant is a variant obtained by substitution and/or deletion and/or insertion of 5-30 amino acids in the sequence of SEQ ID NO: 1.
  5. 5. The recombinant protein vaccine of claim 2, wherein the protein and/or protein precursor comprises a protein having at least one RBD sequence and at least one HR sequence derived from the SARS-CoV-2 S protein or a variant thereof.
  6. 6. The recombinant protein vaccine of claim 2, wherein the protein and/or protein precursor comprises the amino acid sequence shown in the sequence SEQ ID NO: 4, or comprises a variant that exhibits homology and the same or similar biological activity with the sequence SEQ ID NO: 4, and is obtained by substitution and/or deletion and/or insertion of at least one amino acid in the sequence SEQ ID NO: 4; preferably, the RBD sequence is a variant obtained by substitution and/or deletion and/or insertion of 1-400 amino acids in the sequence SEQ ID NO: 4; and preferably, the RBD sequence is a variant obtained by substitution and/or deletion and/or insertion of 5-30 amino acids in the sequence SEQ ID NO: 4.
  7. 7. A composition against infection caused by SARS-CoV-2 or a variant thereof, comprising a preparation with an mRNA vaccine and a recombinant protein-based vaccine as active components, wherein said mRNA vaccine is an mRNA vaccine according to claims 1, 3 or 4, and the recombinant protein-based vaccine is a recombinant protein-based vaccine according to claims 2, 5 or 6.
  8. 8. A combination medicinal product against infection caused by SARS-CoV-2 or a variant thereof, comprising an mRNA vaccine and a recombinant protein vaccine against SARS-CoV-2 or a variant thereof, wherein the mRNA vaccine and the recombinant protein vaccine are administered, respectively, simultaneously or sequentially, wherein the mRNA vaccine is the mRNA vaccine according to claims 1, 3 or 4, and the recombinant protein vaccine is the recombinant protein vaccine according to claims 2, 5 or 6.
  9. 9. The mRNA vaccine according to claim 1 or the recombinant protein vaccine according to claim 2, or the combination medicinal product according to claim 8, wherein the mRNA vaccine, recombinant protein vaccine or combination medicinal product is prepared in the form of intramuscular injections, nasal drops, sprays, nasal sprays or inhalation agents.
  10. 10. The combination medicinal product according to claim 8, wherein the protein formed by the RBD sequence and the HR sequence in the recombinant S protein spontaneously forms a trimer.
  11. 11. The combination medicinal product according to claim 8, wherein the homologous amino acid sequence is selected from at least one RBD sequence Alpha, Beta, Gamma, Delta, Omicron.
  12. 12. The combination medicinal product according to claim 10, characterized in that: the protein precursor is linked to a signal peptide and/or a protein tag on a protein that counteracts infection caused by SARS-CoV-2 or a mutant thereof; preferably, the signal peptide comprises a native signal peptide of the S protein or a variant thereof and/or a human tPA signal peptide additionally added before the native signal peptide; preferably, the protein tag is selected from at least one of a histidine tag, a thioredoxin tag, a glutathione transferase-based tag, a ubiquitin-like modifier-based protein tag, a maltose-binding protein-based tag, a c-Myc protein-based tag, and an Avi protein tag; and more preferably, the protein tag is a Trx tag and/or a 6His tag.
  13. 13. The combination medicinal product according to claim 8, wherein the protease recognition site for cutting out the protein tag is further linked to a protein against infection caused by SARS-CoV-2 or a variant thereof; and preferably, the protease is selected from at least one of enterokinase, TEV protease, thrombin, blood coagulation factor Xa, carboxypeptidase A and rhinovirus 3c protease.
  14. 14. Host cells used in the recombinant protein vaccine of claim 2, wherein said host cells are selected from at least one of the following: insect cells, mammalian cells, Escherichia coli, and yeast; preferably, the insect cells are selected from at least one of sf9 cells, sf21 cells, and Hi5 cells; and preferably, the mammalian cells are either CHO cells or HEK293 cells.
  15. 15. The mRNA vaccine according to claim 1 or the recombinant protein-based vaccine according to claim 2, wherein the mRNA vaccine and/or the recombinant protein-based vaccine additionally contain(s) a pharmaceutically acceptable auxiliary substance or adjuvant component.
  16. 16. The combination medicinal product of claim 13, wherein the recombinant protein-based vaccine further comprises a pharmaceutically acceptable auxiliary substance or an adjuvant component; wherein the adjuvant component is an immunological adjuvant; preferably, the immunological adjuvant is selected from at least one of the following: an oil-in-water squalene-based emulsion, an aluminum salt, a calcium salt, a phytosaponin, a phytopolysaccharide, lipid A-monophosphate, a muramyl dipeptide, a muramyl tripeptide, a bacterial toxin, a GM-CSF cytokine, a lipid and a cationic liposomal substance; in addition, the immunological adjuvant satisfies at least one of the following requirements: the oil-in-water squalene-based emulsion is MF59, the aluminum salt is selected from at least one of aluminum hydroxide and alum; the calcium salt is tricalcium phosphate, the phytosaponin is either QS-21 or ISCOM, the phytopolysaccharide is astragalus polysaccharide; the bacterial toxin is selected from at least one of recombinant cholera toxin and diphtheria toxin; the lipid is selected from at least one of the following: phosphatidylethanolamine, phosphatidylcholine, cholesterol, dioleoylphosphatidylethanolamine; the cationic liposomal substance is selected from at least one of the following: (2,3-dioleoyloxypropyl) trimethylammonium chloride, N-[1-(2,3-dioleoyl chloride)propyl]-N,N,N-trimethylamine chloride, cationic cholesterol, dimethyl-2,3-dioleyloxypropyl-2-(2-spermidinecarboxamido)ethylammonium trifluoroacetate, trimethyldodecylammonium bromide, trimethyltetradecylammonium bromide, trimethylhexadecylammonium bromide, dimethyldioctadecylammonium bromide and CpG ODN.
  17. 17. The use of an mRNA vaccine according to any one of claims 1, 3, 4 and 9, a recombinant protein vaccine according to any one of claims 2, 5, 6 and 9, a composition according to claim 7 or a combination medicinal product according to any one of claims 8, 9-13 in the production of medicinal products for the prevention and/or treatment of infection caused by SARS-CoV-2 or a variant thereof.
  18. 18. The use of an mRNA vaccine according to any one of claims 1, 3, 4 and 9, a recombinant protein vaccine according to any one of claims 2, 5, 6 and 9, a composition according to claim 7 or a combination medicinal product according to any one of claims 8, 9-13 in the production of medicinal products for the treatment and/or prevention of infection or pathogenicity caused by variant strains of SARS-CoV-2, wherein the variant strains of SARS-CoV-2 include at least one of Alpha, Beta, Gamma, Delta and Omicron.