US2021060150A1PendingUtilityA1

Novel adenovirus

Assignee: GLAXOSMITHKLINE BIOLOGICALS SAPriority: Jul 27, 2015Filed: Aug 6, 2020Published: Mar 4, 2021
Est. expiryJul 27, 2035(~9 yrs left)· nominal 20-yr term from priority
C12N 15/86A61K 2039/545A61P 31/06C12N 2710/10321C12N 2710/10341C12N 2740/16234C12N 2760/18534A61K 39/04A61K 2039/5256A61K 39/235A61K 39/12C12N 7/00C07K 14/35A61K 35/761A61K 9/0019C12N 2710/10343A61K 39/39C07K 14/005C12N 15/85A61K 45/05
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Claims

Abstract

There is provided adenoviral vectors encoding a mycobacterial antigen derived from a chimp adenovirus, and to related aspects.

Claims

exact text as granted — not AI-modified
1 - 95 . (canceled) 
     
     
         96 . An immunogenic composition for generating a T cell response in a subject, the immunogenic composition comprising:
 a first composition to be administered to the subject including a recombinant adenovirus comprising a polynucleotide comprising:   (a) a first polynucleotide which encodes a polypeptide having the amino acid sequence according to SEQ ID NO: 1,   (b) a second polynucleotide which encodes a polypeptide having the amino acid sequence according to SEQ ID NO: 5,   (c) a third polynucleotide which encodes a polypeptide having the amino acid sequence according to SEQ ID NO: 3, and   (d) a fourth polynucleotide which encodes a mycobacterial Rv1196 antigen consisting of the amino acid sequence of SEQ ID NO:68, wherein the fourth polynucleotide is operatively linked to one or more sequences which direct expression of said mycobacterial Rv1196 antigen in a host cell.   
     
     
         97 . The immunogenic composition of  claim 96 , further comprising:
 a second composition to be administered after the first composition, said second composition including a further component comprising:
 (a) a non-adenoviral vector or a non-viral vector; or 
 (b) a protein. 
   
     
     
         98 . The immunogenic composition of  claim 97 , wherein the second composition includes a protein comprising the mycobacterial Rv1196 antigen. 
     
     
         99 . The immunogenic composition of  claim 96 , further comprising the first composition and a pharmaceutically acceptable excipient. 
     
     
         100 . The immunogenic composition of  claim 97 , further comprising the second composition and a pharmaceutically acceptable excipient. 
     
     
         101 . The immunogenic composition of  claim 96 , wherein the recombinant adenovirus is replication-incompetent. 
     
     
         102 . The adenovirus of  claim 96 , further comprising a fifth polynucleotide that consists of the amino acid sequence of SEQ ID NO: 70 and encodes a mycobacterial antigen. 
     
     
         103 . The adenovirus of  claim 96 , wherein the one or more sequences which direct expression of said mycobacterial Rv1196 antigen in a host cell includes a promoter sequence, wherein the promoter sequence is selected from the group consisting of an internal promoter, a native promoter, an RSV LTR promoter, a CMV promoter, an SV40 promoter, a dihydrofolate reductase promoter, a β-actin promoter, a PGK promoter, an EF1a promoter and a CASI promoter. 
     
     
         104 . The adenovirus according to  claim 103 , wherein the adenovirus has a non seroprevalence in human subjects. 
     
     
         105 . The adenovirus according to  claim 96 , wherein the adenovirus is a chimpanzee adenovirus. 
     
     
         106 . The composition of  claim 98 , further comprising an adjuvant. 
     
     
         107 . The composition of  claim 106 , wherein the adjuvant is selected from the group consisting of: an inorganic adjuvant, an organic adjuvant, an oil-based adjuvant, a cytokine, a particulate adjuvant, a virosome, a bacterial adjuvant, a synthetic adjuvant, a synthetic polynucleotide adjuvant, or an immunostimulatory oligonucleotide containing unmethylated CpG dinucleotides. 
     
     
         108 . The composition of  claim 107 , wherein the adjuvant is an organic adjuvant. 
     
     
         109 . The composition of  claim 108 , wherein the organic adjuvant is a saponin. 
     
     
         110 . A method for the prophylaxis of mycobacterial infection comprising administering the immunogenic composition according to  claim 96 . 
     
     
         111 . A method for the prophylaxis of mycobacterial infection comprising administering the immunogenic composition according to  claim 97 . 
     
     
         112 . The method of  claim 111 , wherein the second composition is co-administered or sequentially administered with the first composition. 
     
     
         113 . A method for the treatment of mycobacterial infection comprising administering the immunogenic composition according to  claim 96 . 
     
     
         114 . A method for the treatment of mycobacterial infection comprising administering the immunogenic composition according to  claim 97 . 
     
     
         115 . The method of  claim 114 , wherein the second composition is co-administered or sequentially administered with the first composition.

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