The present disclosure provides compositions and methods for detecting the presence of neutralizing antibodies in a sample. Unlike conventional assays, the methods provided herein do not require the use of live virus or virus pseudoparticles to identify neutralizing antibodies.

Provided is a strain that is effective as an active ingredient of a vaccine against betacoronavirus. This SARS-CoV-2 includes non-structural protein(s) that has the following responsible mutation(s): a mutation in the amino acid residue corresponding to the L of position 445 of SEQ ID NO: 1 in NSP3; a mutation in the amino acid residues corresponding to the G of position 248 and the G of position 416 of SEQ ID NO: 2 in NSP14; and/or a mutation in the amino acid residue corresponding to the V of position 67 of SEQ ID NO: 3 in NSP16.

The present invention is directed to a nucleic acid suitable for use in treatment or prophylaxis of an infection with a coronavirus, preferably with a Coronavirus SARS-CoV-2, or a disorder related to such an infection, preferably COVID-19. The present invention is also directed to compositions, polypeptides, and vaccines. The compositions and vaccines preferably comprise at least one of said nucleic acid sequences, preferably nucleic acid sequences in association a lipid nanoparticle (LNP). The invention is also directed to first and second medical uses of the nucleic acid, the composition, the polypeptide, the combination, the vaccine, and the kit, and to methods of treating or preventing a coronavirus infection, preferably a Coronavirus infection.

Timely development of vaccines and antiviral drugs is critical to control the COVID-19 pandemic. Current methods for quantifying vaccine-induced neutralizing antibodies involve the use of pseudoviruses, such as the SARS-CoV-2 spike protein (S) pseudotyped lentivirus. However, these pseudoviruses contain structural proteins foreign to SARS-CoV-2, and require days to infect and express reporter genes. Here, the present application discloses composition and methodology for making and using a new hybrid alphavirus-SARS-CoV-2 (Ha-CoV-2) particle for rapid and accurate quantification of neutralization antibodies and viral variants.

Attenuated isolates of the Arkansas serotype of infectious bronchitis virus (IBV), including the IBV isolate ArkGA p40 deposited at the ATCC under Patent Designation PTA-126834, and compositions thereof are presented. Methods for administering the isolates or compositions as vaccines to the prevent virulent IBV infection in birds of the order Galliformes are also presented.

The invention relates to a biomolecule agent for inducing specific immunity against severe acute respiratory syndrome virus SARS-CoV-2, in liquid form, which contains a single active component, comprising the expression vector including either: the genome of the recombinant strain of human adenovirus serotype 26 or 5, wherein the E1 and E3 regions are deleted, the vector with an integrated expression cassette is selected from SEQ ID NO:1, SEQ ID NO:2, or SEQ ID NO:3; or the recombinant strain of simian adenovirus serotype 25, wherein the E1 and E3 regions are deleted, the vector with an integrated expression cassette selected from SEQ ID NO:4, SEQ ID NO:2, or SEQ ID NO:3. The recombinant strain of human adenovirus serotype 26 may include the ORF6-Ad26 region replaced by ORF6-Ad5.

A buffer solution of the agent in liquid form contains the following, by mass %: tris from 0.1831 to 0.3432; sodium chloride from 0.3313-0.6212; sucrose from 3.7821-7.0915; magnesium chloride hexahydrate from 0.0154-0.0289; EDTA from 0.0029-0.0054; polysorbate-80 from 0.0378-0.0709; ethanol 95% from 0.0004-0.0007; and water to fill.

The agent can be administered via intranasal and/or intramuscular routes. The invention promotes humoral and cell-mediated immune responses against SARS-CoV-2 virus among broad strata of the population.

The present inventors discovered that antibodies having weaker antigen-binding activity at the early endosomal pH in comparison with that at the pH of plasma are capable of binding to multiple antigen molecules with a single antibody molecule, have long half-lives in plasma, and have improved durations of time in which they can bind to antigen.

The present disclosure provides compositions and methods for detecting the presence of neutralizing antibodies in a sample. Unlike conventional assays, the methods provided herein do not require the use of live virus or virus pseudoparticles to identify neutralizing antibodies.

Covalently modified polypeptide antigens having improved immunogenicity and/or stability, as well as compositions, cells, and methods relating thereto, are described herein. Polypeptide antigens are covalently conjugated to a one or more of steroid acid moieties to improve their stability and/or to trigger improved cellular immunity, or improved cellular and humoral immunity, against the antigen upon administration to a subject. The steroid acids include bile acids and bile acid analogs that enhance endocytosis and/or endosomal escape of endosomally trapped cargoes by potentiating enzymatic cleavage of sphingomyelin to ceramide within endosomal membranes. The steroid acid moieties may be pre-conjugated to a peptide, and the steroid acid-peptide moiety subsequently conjugated to the polypeptide antigen. The peptide may comprise one or more domains that impart an additional functionality to the modified polypeptide antigen.

The invention relates to immunogenic compositions and vaccines containing a coronavirus (e.g., Wuhan coronavirus (2019-nCoV; also referred to as SARS-CoV-2)) protein or a polynucleotide encoding a coronavirus (e.g., Wuhan coronavirus (2019-nCoV; SARS-CoV-2)) protein and uses thereof. The invention also provides methods of treating and/or preventing a coronavirus (e.g., Wuhan coronavirus (2019-nCoV; SARS-CoV-2)) infection by administering an immunogenic composition or vaccine to a subject (e.g., a human). The invention also provides methods of detecting and/or monitoring a protective anti-coronavirus (e.g., Wuhan coronavirus (2019-nCoV; SARS-CoV-2)) antibody response (e.g., anti-coronavirus antibody response, e.g., anti-2019-nCoV antibody response, e.g., anti-Spike antibody response, e.g., anti-Spike neutralizing antibody response). The present invention relates to isolated nucleic and/or recombinant nucleic acid encoding a coronavirus S protein, in particular a SARS-CoV-2 S protein, and to the coronavirus S proteins, as well as to the use of the nucleic acids and/or proteins thereof in vaccines.