US2023390381A1PendingUtilityA1

Immunogenic combinations

Assignee: GLAXOSMITHKLINE BIOLOGICALS SAPriority: Jun 13, 2014Filed: Dec 15, 2022Published: Dec 7, 2023
Est. expiryJun 13, 2034(~7.9 yrs left)· nominal 20-yr term from priority
A61K 39/155A61K 39/235A61K 39/12A61K 2039/5256A61K 2039/545C12N 2760/18534C12N 2710/10343A61P 31/14A61P 37/04
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Claims

Abstract

This disclosure provides immunogenic combinations that include a) an immunogenic component containing a peptide or polypeptide antigen of a respiratory pathogen; and b) an immunogenic component containing a nucleic acid encoding an antigen of the same respiratory pathogen, wherein the immunogenic components are formulated for concurrent, e.g., co-localized, administration. More specifically, the respiratory pathogen is respiratory syncytial virus (RSV). This disclosure also concerns provides the use of such immunogenic combinations, and methods for administering such immunogenic combinations to elicit an immune response specific for the respiratory pathogen.

Claims

exact text as granted — not AI-modified
1 - 34 . (canceled) 
     
     
         35 . An immunogenic combination of compositions comprising:
 a) a first immunogenic composition comprising an F protein antigen of respiratory syncytial virus (RSV) constrained in the pre-fusion conformation; and   b) a second immunogenic composition comprising an adenoviral vector comprising a nucleic acid encoding an F protein antigen of respiratory syncytial virus (RSV);   wherein the first immunogenic composition and the second immunogenic composition are formulated in a single composition (co-formulated).   
     
     
         36 . The immunogenic combination of  claim 35 , wherein the antigens of the first and second immunogenic compositions comprise one or more identical immunogenic epitopes. 
     
     
         37 . The immunogenic combination of  claim 35 , wherein the first and at least second immunogenic composition comprise a plurality of antigens. 
     
     
         38 . The immunogenic combination of  claim 35 , wherein the second immunogenic composition comprises a nucleic acid that encodes an ectodomain of an RSV F Protein (FΔTM). 
     
     
         39 . The immunogenic combination of  claim 35 , wherein the second immunogenic composition comprises a nucleic acid that encodes an RSV FΔTM antigen and RSV M2-1 and N antigens. 
     
     
         40 . The immunogenic combination of  claim 39  wherein a self-cleavage site is included between the RSV FΔTM antigen and the RSV M2-1 and a flexible linker is included between the RSV M2-1 and N antigens. 
     
     
         41 . The immunogenic combination of  claim 35 , wherein the at least one of the first and/or second immunogenic composition further comprises one or more selected from the group consisting of: a carrier, an excipient, a buffer and an adjuvant. 
     
     
         42 . The immunogenic combination of  claim 41 , wherein the adjuvant comprises one or more selected from the group consisting of: a metallic salt, 3-D-monophosphoryl-lipid-A (MPL), a saponin, and an oil and water emulsion, a liposome and a nanoparticle. 
     
     
         43 . The immunogenic combination of  claim 42 , wherein the metallic salt is (i) an aluminum salt selected from the group consisting of: aluminum hydroxide, aluminum potassium sulfate, aluminum hydroxyphosphate sulfate, and aluminum phosphate, or (ii) a calcium salt is selected from the group consisting of: calcium phosphate and calcium fluoride. 
     
     
         44 . A method for eliciting an immune response specific for respiratory syncytial virus (RSV) in a subject, the method comprising a step of administering the immunogenic combination of  claim 35  to the subject. 
     
     
         45 . A method for preventing, reducing, or treating an infection by respiratory syncytial virus (RSV) in a subject comprising a step of administering the immunogenic combination of  claim 35  to the subject. 
     
     
         46 . A process for making the immunogenic combination of  claim 35  comprising a step of co-formulating a first immunogenic composition comprising an F protein antigen of respiratory syncytial virus (RSV) constrained in the pre-fusion conformation and a second immunogenic composition comprising an adenoviral vector comprising a nucleic acid encoding an F protein antigen of respiratory syncytial virus (RSV). 
     
     
         47 . A method of vaccination for the prevention, reduction or treatment of infection by respiratory syncytial virus (RSV), comprising a step of concurrently administering an immunogenic combination of  claim 35 .

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