| abstract |
The present invention provides a biomolecule preparation for inducing specific immunity against SARS-CoV-2, a lyophilized (freeze-dried) form of severe acute respiratory syndrome virus, containing a single active ingredient, human adenovirus serotype 26 or a genome of a recombinant strain of 5, wherein the E1 and E3 regions are deleted, and an integrated expression cassette selected from SEQ ID NO: 1, SEQ ID NO: 2 or SEQ ID NO: 3, or recombination of simian adenovirus serotype 25 and an expression vector comprising the genome of the strain, wherein E1 and E3 are deleted, and an integrated expression cassette selected from SEQ ID NO:4, SEQ ID NO:2 or SEQ ID NO:3. The genome of the recombinant strain of human adenovirus serotype 26 may comprise an ORF6-Ad26 region replaced by ORF6-Ad5. Buffers for reconstitution of preparations in lyophilized form may contain the following mass%: Tris of 0.0180-0.0338; 0.1044-0.1957 sodium chloride; sucrose from 5.4688-10.2539; 0.0015-0.0028 magnesium chloride hexahydrate; EDTA of 0.0003-0.0005; polysorbate-80 from 0.0037-0.0070; and a fill amount of water. The formulation may be administered via the intranasal and/or intramuscular route. The present invention promotes humoral and cell-mediated immune responses against SARS-CoV-2 virus among broad layers of a population. |