Novel vaccine adjuvant

Abstract

There is provided a novel vaccine adjuvant, and more specifically, a vaccine adjuvant for stimulating a T lymphocyte-specific immune response, which includes an IL-12 protein and an IL-21 protein as active ingredients, or includes the polynucleotide encoding an IL-12 protein and the polynucleotide encoding an IL-21 protein as active ingredients.

1 .- 16 . (canceled) 
     
     
         17 . A method for stimulating a T lymphocyte-specific immune response by a vaccine composition in a subject comprising administering an adjuvant composition comprising i) IL-12 protein and IL-21 protein; or ii) a polynucleotide encoding a p35 chain of IL-12 protein (IL-12p35), a polynucleotide encoding a p40 chain of IL-12 protein (IL-12p40) and a polynucleotide encoding an IL-21 protein along with the vaccine composition to the subject,
 wherein the adjuvant composition induces a lower antibody response compared to when the vaccine composition is treated alone.   
     
     
         18 . The method of  claim 17 , wherein each of the polynucleotides is operably linked to a promoter or
 an internal ribosome entry site (IRES) links between at least two of the polynucleotides and the polynucleotides including the IRES is operably linked to a promoter.   
     
     
         19 . The method of  claim 17 , wherein the adjuvant composition comprises one to three vectors, each of which comprises: polynucleotides that respectively encode the IL-12p35 and the IL-12p40; and a polynucleotide that encodes the IL-21 protein; or mRNA molecules, each of which encodes the IL-12p35, IL-12p40, and IL-21 proteins. 
     
     
         20 . The method of  claim 17 , wherein the IL-12p35 is a human IL-12p35 consisting of the amino acid sequence of SEQ ID NO: 1. 
     
     
         21 . The method of  claim 17 , wherein the IL-12p40 is a human IL-12p40 consisting of the amino acid sequence of SEQ ID NO: 2. 
     
     
         22 . The method of  claim 17 , wherein the IL-21 protein is a human IL-21 consisting of the amino acid sequence of SEQ ID NO: 3. 
     
     
         23 . The method of  claim 17 , the adjuvant composition further comprises at least one among:
 a MIP-1α gene construct, in which a polynucleotide encoding the MIP-1α protein is operably linked to a promoter;   a complex gene construct, in which a polynucleotide encoding the MIP-1α protein is operably linked to at least one among the IL-12p35, IL-12p40, and IL-21 proteins, by a polynucleotide encoding an internal ribosome entry site (IRES) or linker peptide; and   a mRNA molecule encoding MIP-1α protein.   
     
     
         24 . The method of  claim 23 , wherein the MIP-1α protein consists of the amino acid sequence of SEQ ID NO: 10. 
     
     
         25 . The method  claim 23 , wherein the MIP-1α gene construct is comprised in a separate expression vector or comprised in any one or more of the one to three vectors, each of which comprises: polynucleotides that respectively encode a p35 chain (IL-12p35) and a p40 chain (IL-12p40) that constitute the IL-12 protein; and a polynucleotide that encodes the IL-21 protein. 
     
     
         26 . The method of  claim 17 , wherein the vaccine composition comprises at least one antigen derived from infectious virus or at least one cancer antigen or a polynucleotide encoding the antigen derived from infectious virus or the cancer antigen. 
     
     
         27 . The method of  claim 26 , wherein the infectious virus is Epstein-Barr virus (EBV), hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV), Hantaan virus, cytomegalovirus (CMV), human immunodeficiency virus (HIV), influenza virus, human papillomavirus (HPV), poliovirus, ebola virus, rotavirus, dengue virus, West Nile virus, yellow fever virus, adenovirus, Japanese encephalitis virus, BK virus, smallpox virus, Zika virus, severe fever with thrombocytopenia syndrome (SFTS) virus, or herpes simplex virus (HSV). 
     
     
         28 . The method of  claim 26 , wherein the cancer antigen is a human papillomavirus (HPV)-derived antigen, a carcinoembryonic antigen, a prostate-specific membrane antigen (PSMA), Her2/neu, MUC-1, BCR/ABL, α-fetoprotein (AFP), an Epstein-Barr virus (EBV)-derived antigen, a human hepatitis B virus (HBV)-derived antigen, a human hepatitis C virus (HCV)-derived antigen, cancer antigen-125 (CA-125), cancer antigen-72-4 (CA-72-4), cancer antigen-15-3 (CA-15-3), or cancer antigen-19-9 (CA-19-9). 
     
     
         29 . The method of  claim 17 , wherein the adjuvant composition is administrated via intramuscular injection, intravenous injection or electroporation.