# US 11,998,597 B2 · Vaccine against RSV > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,998,597 B2 - Document ID: US11998597B2 - Status: Granted - Kind: B2 - Application number: 17/572,097 - Filed: 2022-01-10 - Published: 2022-04-28 - Granted: 2024-06-04 - Earliest claimed: 2015-07-07 - Assignees: Janssen Vaccines & Prevention B.V. - Applicants: Janssen Vaccines & Prevention B.V. - Inventors: Johannes Petrus Maria Langedijk; Dirk André Emmy Roymans - Web page: https://patentgrep.com/patent/US11998597B2 ## CPC - A61K 39/155: Paramyxoviridae, e.g. parainfluenza virus - A61K 39/12: Viral antigens - A61P 31/14: for RNA viruses - C07K 14/005: from viruses - C07K 2319/00: Fusion polypeptide - C12N 2760/18522: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes - C12N 2760/18534: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) ## Abstract Compositions including a recombinant respiratory syncytial virus (RSV) Fusion (F) polypeptide that is stabilized in the pre-fusion conformation are described. The RSV F polypeptide includes at least one mutation as compared to a wild type RSV F polypeptide and the at least one mutation is a) a mutation of the amino acid aspartic acid (D) on position 486, b) a mutation of the amino acid aspartic acid (D) on position 489, or c) a mutation of the amino acid serine (S) on position 398 and/or the amino acid lysine (K) on position 394. Compositions including an isolated nucleic acid molecule encoding the stable RSV F polypeptides are also described. ## Claims ### Claim 1 An adenovirus type 26 (Ad26) vector comprising a nucleic acid encoding a recombinant respiratory syncytial virus (RSV) Fusion (F) polypeptide, wherein, as compared to a wild type RSV F polypeptide, the recombinant RSV F polypeptide comprises: (i) a mutation of the amino acid at position 486 from aspartic acid (D) to asparagine (N), (ii) at least one of a. a mutation of the amino acid residue at position 67 from asparagine (N) or threonine (T) to isoleucine (I), and b. a mutation of the amino acid residue at position 215 from serine (S) to proline (P), and (iii) one or more additional mutations. ### Claim 2 (depends on 1) The Ad26 vector of claim 1, wherein the recombinant RSV F polypeptide comprises at least one epitope that is recognized by a pre-fusion specific monoclonal antibody comprising a heavy chain variable region having a heavy chain complementary determining region (HCDR)1 of the amino acid sequence of SEQ ID NO: 4, a HCDR2 of the amino acid sequence of SEQ ID NO: 5, and a HCDR3 of the amino acid sequence of SEQ ID NO: 6, and a light chain variable region having a light chain complementary determining region (LCDR)1 of the amino acid sequence of SEQ ID NO: 7, a LCDR2 of the amino acid sequence of SEQ ID NO: 8, and a LCDR3 of the amino acid sequence of SEQ ID NO: 9. ### Claim 3 (depends on 1) The Ad26 vector according to claim 1, wherein the recombinant RSV F polypeptide comprises: (i) the mutation of the amino acid residue at position 486 from aspartic acid (D) to asparagine (N), (ii) the mutation of the amino acid residue at position 67 from asparagine (N) or threonine (T) to isoleucine (I), and (iii) the mutation of the amino acid residue at position 215 from serine (5) to proline (P). ### Claim 4 (depends on 2) The Ad26 vector according to claim 2, wherein the pre-fusion specific monoclonal antibody comprises the heavy chain variable region having amino acids 1-125 of SEQ ID NO: 16, and the light chain variable region having amino acids 1-107 of SEQ ID NO: 17. ### Claim 5 (depends on 1) A composition comprising the Ad26 vector according to claim 1 and a pharmaceutically acceptable carrier. ### Claim 6 (depends on 2) A composition comprising the Ad26 vector according to claim 2 and a pharmaceutically acceptable carrier. ### Claim 7 (depends on 3) A composition comprising the Ad26 vector according to claim 3 and a pharmaceutically acceptable carrier. ### Claim 8 (depends on 4) A composition comprising the Ad26 vector according to claim 4 and a pharmaceutically acceptable carrier. ### Claim 9 (depends on 1) A method of inducing an immune response against RSV in a subject in need thereof, the method comprising administering to the subject a composition comprising the Ad26 vector according to claim 1 and a pharmaceutically acceptable carrier. ### Claim 10 (depends on 9) The method of claim 9, wherein the composition is administered to the subject intramuscularly. ### Claim 11 (depends on 9) The method according to claim 9, wherein the composition is administered to the subject more than once. ### Claim 12 (depends on 9) The method according to claim 9, wherein the induced immune response comprises inducing neutralizing antibodies to RSV. ### Claim 13 (depends on 2) A method of inducing an immune response against RSV in a subject in need thereof, the method comprising administering to the subject a composition comprising the Ad26 vector according to claim 2 and a pharmaceutically acceptable carrier. ### Claim 14 (depends on 13) The method of claim 13, wherein the composition is administered to the subject intramuscularly. ### Claim 15 (depends on 13) The method according to claim 13, wherein the composition is administered to the subject more than once. ### Claim 16 (depends on 13) The method according to claim 13, wherein the induced immune response comprises inducing neutralizing antibodies to RSV. ### Claim 17 (depends on 3) A method of inducing an immune response against RSV in a subject in need thereof, the method comprising administering to the subject a composition comprising the Ad26 vector according to claim 3 and a pharmaceutically acceptable carrier. ### Claim 18 (depends on 17) The method of claim 17, wherein the composition is administered to the subject intramuscularly. ### Claim 19 (depends on 17) The method according to claim 17, wherein the composition is administered to the subject more than once. ### Claim 20 (depends on 17) The method according to claim 17, wherein the induced immune response comprises inducing neutralizing antibodies to RSV.