# US 8,771,709 B2 · Therapeutic vaccination against active Tuberculosis > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,771,709 B2 - Document ID: US8771709B2 - Status: Granted - Kind: B2 - Application number: 13/822,593 - Filed: 2011-09-19 - Published: 2013-07-04 - Granted: 2014-07-08 - Earliest claimed: 2010-09-20 - Assignees: Crucell Holland B.V. - Applicants: Jerald Sadoff; Anisah Alyahya - Inventors: Jerald Sadoff; Anisah Alyahya - Web page: https://patentgrep.com/patent/US8771709B2 ## CPC - A61K 39/04: Mycobacterium, e.g. Mycobacterium tuberculosis - A61K 31/133: having hydroxy groups, e.g. sphingosine - A61K 31/455: Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides - A61K 31/496: Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin - A61K 31/4965: Non-condensed pyrazines - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 31/06: for tuberculosis - C07K 14/35: from Mycobacteriaceae (F) - A61K 2039/5254: {avirulent or attenuated} - A61K 2039/5256: {expressing foreign proteins} - A61K 2039/53: {DNA (RNA) vaccination} - A61K 2039/545: {characterised by the dose, timing or administration schedule} - A61K 2039/57: {characterised by the type of response, e.g. Th1, Th2} - 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) ## Abstract The invention provides a method for therapeutic treatment of a patient having active tuberculosis (TB), the method comprising: administering to the patient a recombinant adenovirus vector that comprises nucleic acid encoding the Ag85A, Ag85B and TB10.4 antigens of Mycobactium tuberculosis (Mtb). Advantageously, the method can be used to shorten conventional drug therapy for treating active TB. ## Claims ### Claim 1 A method of treating a patient having active tuberculosis (TB), the method comprising: administering to the patient a recombinant adenovirus vector comprising nucleic acid encoding Ag85A, Ag85B, and TB10.4 antigens of Mycobacterium tuberculosis, and treating the patient further with drug therapy for tuberculosis, wherein the drug therapy comprises: administration of isoniazid, rifampin, pyrazinamide, and ethambutol to the patient. ### Claim 2 A method of treating a patient having active tuberculosis (TB), the method comprising: administering to the patient a recombinant adenovirus vector comprising nucleic acid encoding Ag85A, Ag85B, and TB10.4 antigens of Mycobacterium tuberculosis (Mtb), and treating the patient further with drug therapy for tuberculosis, wherein the bacterial burden of Mtb as measured in a group of patients at a given time after the initiation of drug therapy is lower as compared to the burden at the same time point without the administration of said recombinant adenovirus vector. ### Claim 3 (depends on 1) The method according to claim 1, wherein the nucleic acid encodes Ag85A, Ag85B and TB10.4 antigens as a fusion protein. ### Claim 4 (depends on 1) The method according to claim 1, wherein the recombinant adenovirus vector is a replication-deficient human adenovirus of serotype 35. ### Claim 5 A method of treating a patient having active tuberculosis, the method comprising: administering to the patient a recombinant adenovirus vector comprising nucleic acid encoding Ag85A, Ag85B, and TB10.4 antigens of Mycobacterium tuberculosis, wherein the recombinant adenovirus vector is a replication-deficient human adenovirus of serotype 26. ### Claim 6 A method of treating a patient having active tuberculosis (TB), the method comprising: administering to the patient a recombinant adenovirus vector comprising nucleic acid encoding Ag85A, Ag85B, and TB10.4 antigens of Mycobacterium tuberculosis (Mtb), wherein the recombinant adenovirus vector is administered in a heterologous prime-boost regimen. ### Claim 7 (depends on 6) The method according to claim 6, wherein the heterologous prime-boost regimen comprises administration of vectors of a recombinant human adenovirus serotype 35 vector comprising nucleic acid encoding Ag85A, Ag85B and TB10.4 antigens of Mtb and of a recombinant human adenovirus serotype 26 vector comprising nucleic acid encoding Ag85A, Ag85B and TB10.4 antigens of Mtb. ### Claim 8 A method of treating a patient having active tuberculosis (TB), the method comprising: administering to the patient a recombinant adenovirus vector comprising nucleic acid encoding Ag85A, Ag85B, and TB10.4 antigens of Mycobacterium tuberculosis (Mtb), wherein the TB is pulmonary TB. ### Claim 9 A method of treating a patient having active tuberculosis (TB), the method comprising: administering to the patient a recombinant adenovirus vector comprising nucleic acid encoding Ag85A, Ag85B, and TB10.4 antigens of Mycobacterium tuberculosis (Mtb), wherein the patient has an infection with multidrug-resistant Mtb (MDR-TB) or extremely drug-resistant Mtb (XDR-TB). ### Claim 10 A method of treating a patient having active tuberculosis, the method comprising: administering to the patient a recombinant adenovirus vector comprising nucleic acid encoding Ag85A, Ag85B, and TB10.4 antigens of Mycobacterium tuberculosis (Mtb), wherein the recombinant adenovirus vector comprising nucleic acid encoding Ag85A, Ag85B, and TB10.4 antigens of Mtb is administered to the patient more than once.