US2021322544A1PendingUtilityA1

Vaccine composition comprising hepatitis b virus-like particle as adjuvant

Assignee: UNIV NAT TAIWANPriority: Nov 22, 2016Filed: Jul 1, 2021Published: Oct 21, 2021
Est. expiryNov 22, 2036(~10.3 yrs left)· nominal 20-yr term from priority
A61K 39/155C12N 2760/18534C07K 14/02Y02A50/30A61K 2039/55588A61K 39/12A61K 2039/541A61P 31/12A61P 31/14C12N 7/00A61K 2039/5258C12N 2730/10123A61K 39/39C07K 14/005A61K 2039/543A61K 2039/55555A61K 2039/55561C12N 2760/18571C12N 2730/10134
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Claims

Abstract

The present disclosure provides vaccine compositions and methods for inducing a systemic immune response and a mucosal immune response, wherein the vaccine compositions comprise an antigen and a hepatitis B core virus-like particle (HBc VLP) as adjuvant. The vaccine compositions are suitable for administration to the mucosa surface of subject, and are effective in eliciting a protective immune response against infection.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method to induce immune response to an antigen in a subject, comprising administering to the subject in need thereof an adjuvant that is hepatitis B core virus-like particle (HBc VLP) having an amino acid sequence at least 80% identical to SEQ ID NO:1. 
     
     
         2 . The method of  claim 1 , wherein the antigen is selected from the group consisting of human immunodeficiency virus, varicella zoster virus, herpes simplex virus type 1, herpes simplex virus type 2, human cytomegalo virus, dengue virus, hepatitis A, B, C or E virus, respiratory syncytial virus (RSV), severe acute respiratory syndrome virus (SARS virus), human papilloma virus, influenza virus,  Haemophilus influenzae  type b (Hib), meningitis virus,  Salmonella, Neisseria, Borrelia,  20  Chlamydia, Bordetella , enterotoxic  E. coli, Campylobacter, Streptococcus, Moraxella, Mycoplasma, Mycobacteria, Haemophilus, Plasmodium, Toxoplasma , and Stanworth decapeptide. 
     
     
         3 . The method of  claim 1 , wherein the antigen is RSV. 
     
     
         4 . The method of  claim 1 , wherein the antigen is severe acute respiratory syndrome virus. 
     
     
         5 . The method of  claim 1 , wherein the immune response is mucosal immune response. 
     
     
         6 . The method of  claim 1 , wherein the immune response is systemic immune response. 
     
     
         7 . The method of  claim 1 , wherein the HBc VLP having an amino acid sequence of SEQ ID NO: 1. 
     
     
         8 . The method of  claim 1 , wherein the adjuvant is suitable for oral, nasal, rectal, or vaginal application. 
     
     
         9 . A vaccine composition, comprising:
 (a) an antigen, wherein said antigen is selected from the group consisting of human immunodeficiency virus, varicella zoster virus, herpes simplex virus type 1, herpes simplex virus type 2, human cytomegalo virus, dengue virus, hepatitis A, B, C or E virus, severe acute respiratory syndrome virus (SARS virus), human papilloma virus, influenza virus,  Haemophilus influenzae  type b (Hib), meningitis virus,  Salmonella, Neisseria, Borrelia,  20  Chlamydia, Bordetella , enterotoxic  E. coli, Campylobacter, Streptococcus, Moraxella, Mycoplasma, Mycobacteria, Haemophilus, Plasmodium, Toxoplasma , and Stanworth decapeptide; and   (b) an adjuvant that is a hepatitis B core virus-like particle (HBc VLP) having an amino acid sequence at least 80% identical to the amino acid sequence of SEQ ID NO: 1.   
     
     
         10 . The vaccine of  claim 9 , wherein the antigen is severe acute respiratory syndrome virus. 
     
     
         11 . The vaccine of  claim 9 , wherein the HBc VLP having the amino acid sequence of SEQ ID NO: 1. 
     
     
         12 . The vaccine of  claim 9 , wherein the adjuvant is present in an adjuvant-effective amount of 0.1 μg to 1000 μg. 
     
     
         13 . The vaccine of  claim 9 , wherein the vaccine having a weight ratio of the antigen to the adjuvant from 10:1 to 1:10. 
     
     
         14 . The vaccine of  claim 9 , wherein the weight ratio of the antigen to the adjuvant is from 5:1 to 1:5. 
     
     
         15 . The vaccine of  claim 9 , wherein the vaccine is suitable for mucosal vaccination. 
     
     
         16 . The vaccine of  claim 9 , wherein the vaccine is suitable for oral, nasal, rectal, or vaginal application. 
     
     
         17 . The vaccine of  claim 9 , wherein the vaccine induces a mucosal immune response. 
     
     
         18 . The vaccine of  claim 9 , wherein the vaccine induces a systemic immune response. 
     
     
         19 . A method of inducing an immune response in a subject, comprising administering a vaccine to the subject in need thereof, said vaccine comprising:
 (a) an antigen selected from the group consisting of human immunodeficiency virus, varicella zoster virus, herpes simplex virus type 1, herpes simplex virus type 2, human cytomegalo virus, dengue virus, hepatitis A, B, C or E virus, severe acute respiratory syndrome virus (SARS virus), human papilloma virus, influenza virus,  Haemophilus influenzae  type b (Hib), meningitis virus,  Salmonella, Neisseria, Borrelia,  20  Chlamydia, Bordetella , enterotoxic  E. coli, Campylobacter, Streptococcus, Moraxella, Mycoplasma, Mycobacteria, Haemophilus, Plasmodium, Toxoplasma , and Stanworth decapeptide; and   (b) an adjuvant that is a hepatitis B core virus-like particle (HBc VLP) having an amino acid sequence at least 80% identical to the amino acid sequence of SEQ ID NO: 1   
     
     
         20 . The method of  claim 19 , wherein said immune response is mucosal immune response.

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