Adjuvant for mucosal vaccine

Abstract

An object of the present invention is to provide an adjuvant for a mucosal vaccine with high safety that induces a sufficient immune response on the mucosa. According to the present invention, an adjuvant for a mucosal vaccine comprising a protein complex composed of hemagglutinin (HA) subcomponents HA1, HA2, and HA3 of botulinum toxin is provided.

1 . An adjuvant for a mucosal vaccine comprising a protein complex composed of hemagglutinin (HA) subcomponents HA1, HA2, and HA3 of botulinum toxin. 
     
     
         2 . The adjuvant according to  claim 1 , wherein the protein complex is composed of the first component, the second component, and the third component described below: 
       the first component:
 (a) a protein consisting of the amino acid sequence as shown in SEQ ID NO: 1, or 
 (b) a protein consisting of an amino acid sequence derived from the amino acid sequence as shown in SEQ ID NO: 1 by deletion, substitution, or addition of one to several amino acids and having functions equivalent to those of the protein (a); 
 
       the second component:
 (c) a protein consisting of the amino acid sequence as shown in SEQ ID NO: 2, or 
 (d) a protein consisting of an amino acid sequence derived from the amino acid sequence as shown in SEQ ID NO: 2 by deletion, substitution, or addition of one to several amino acids and having functions equivalent to those of the protein (c); and 
 
       the third component:
 (e) a protein consisting of the amino acid sequence as shown in SEQ ID NO: 3, or 
 (f) a protein consisting of an amino acid sequence derived from the amino acid sequence as shown in SEQ ID NO: 3 by deletion, substitution, or addition of one to several amino acids and having functions equivalent to those of the protein (e). 
 
     
     
         3 . The adjuvant according to  claim 1 , which is used simultaneously with vaccine antigens or before or after vaccine antigens are administered. 
     
     
         4 . The adjuvant according to  claim 3 , wherein the vaccine antigens are subunit antigens or inactivated antigens. 
     
     
         5 . The adjuvant according to  claim 3 , wherein the vaccine antigens are derived from pathogens causing mucosal infections. 
     
     
         6 . The adjuvant according to  claim 5 , wherein the pathogens causing mucosal infections are viruses or bacteria. 
     
     
         7 . The adjuvant according to  claim 6 , wherein the viruses are influenza viruses, human immunodeficiency viruses (HIV), chickenpox viruses, measles viruses, rubella viruses, mumps viruses, polioviruses, rotaviruses, adenoviruses, herpes viruses, RS viruses, dengue viruses, Japanese encephalitis viruses, severe acute respiratory syndrome (SARS) viruses, or hepatitis viruses. 
     
     
         8 . The adjuvant according to  claim 6 , wherein the bacteria are  Bordetella pertussis, Neisseria meningitidis , type B influenza, pneumococcus, tuberculosis bacteria, tetanus bacilli, or cholera bacilli. 
     
     
         9 . The adjuvant according to  claim 1 , which is administered with any mucosal routes. 
     
     
         10 . The adjuvant according to  claim 9 , wherein the administration with mucosal routes is intranasal administration. 
     
     
         11 . A mucosal vaccine preparation comprising vaccine antigens and the adjuvant according to  claim 1 .