US2003119773A1PendingUtilityA1

Method for enhancing an immune response

56
Priority: Jul 2, 1999Filed: Sep 23, 2002Published: Jun 26, 2003
Est. expiryJul 2, 2019(expired)· nominal 20-yr term from priority
Inventors:Eyal RazHiroko Kobayashi
A61K 2039/57A61P 37/04A61K 45/06A61K 2039/55561A61K 39/39
56
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Claims

Abstract

Disclosed is a method for enhancing an immune response to a substance, such as an antigen or microbial pathogen. The immune response can be, for example, production of IgG2 antibodies. The method comprises administering an immunostimulatory nucleotide sequence (ISS) to a subject at least one hour prior to exposure to the substance by the subject. The subject may be exposed to the substance either naturally, as with an environmental pathogen, or by administration, as with a known antigen. The method can be used for protecting or immunizing a subject against an antigen or pathogen, providing more effective immunization than if the ISS were co-administered with the substance. The method can be used prophylactically or therapeutically. In preferred embodiments, the ISS comprises a CG, p(GC) or p(IC) DNA or RNA nucleotide sequence. Of these, a CG containing nucleotide sequence is preferred. The ISS can further comprise a pG nucleotide sequence. Examples of an ISS include sequences comprising 5′-rrcgyy-3′, 5′-rycgyy-3′, 5′-rrcgyycg-3′ or 5′-rycgyycg-3′. The ISS is preferably administered between about 6 hours and about 6 weeks prior to exposure to the substance, and more preferably between about 1 day and about 4 weeks prior. Most preferably, the ISS is administered between about 3 days and about 8 days prior to exposure to the substance. The ISS can be administered via a mucosal or systemic route. The substance can be an antigen or pathogen associated with an infectious disease, an allergen or a cancer.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . A method for enhancing an immune response to a substance comprising administering an immunostimulatory nucleotide sequence (ISS) to a subject at least one hour prior to exposure to the substance by the subject.  
     
     
         2 . The method of  claim 1 , wherein the immune response is innate immunity.  
     
     
         3 . The method of  claim 1 , wherein the immune response is a Th1 response.  
     
     
         4 . The method of  claim 1 , wherein the immune response includes production of an antibody.  
     
     
         5 . The method of  claim 4 , wherein the antibody is of the IgG2 class.  
     
     
         6 . The method of  claim 1 , wherein the immune response includes release of antigen-specific interferon-γ.  
     
     
         7 . The method of  claim 1 , wherein the immune response includes a cytotoxic T lymphocyte (CTL) response.  
     
     
         8 . The method of  claim 1 , wherein the substance is an antigen or pathogen associated with an infectious disease, an allergen or a cancer.  
     
     
         9 . The method of  claim 8 , wherein the infectious disease is selected from the group comprising viral, bacterial, mycobacterial and parasitic disease.  
     
     
         10 . The method of  claim 1 , wherein the ISS comprises a CG, p(GC) or p(IC) DNA or RNA nucleotide sequence.  
     
     
         11 . The method of  claim 1 , wherein the ISS comprises the sequence 5′-rrcgyy-3′ (SEQ ID NO: 1), 5′-rycgyy-3′ (SEQ ID NO: 2), 5′-rrcgyycg-3′ (SEQ ID NO: 3) or 5′-rycgyycg-3′ (SEQ ID NO: 4).  
     
     
         12 . The method of  claim 11 , wherein the nucleotide sequence is selected from a group comprising AACGTT (SEQ ID NO: 5), AGCGTC (SEQ ID NO: 6), AGCGTT (SEQ ID NO: 7), GACGTT (SEQ ID NO: 8), GGCGTT (SEQ ID NO: 9), AACGTT (SEQ ID NO: 10), GTCGTT (SEQ ID NO: 24), AGCGTCCG (SEQ ID NO: 25), AACGTTCG (SEQ ID NO: 26), AGCGTTCG (SEQ ID NO: 27), GACGTTCG (SEQ ID NO: 28), GGCGTTCG (SEQ ID NO: 29), AACGTTCG 
 (SEQ ID NO: 30), and AGCGTCCG (SEQ ID NO: 31).    
     
     
         13 . The method of  claim 1 , wherein the ISS is administered between about 6 hours and about 6 weeks prior to antigen administration.  
     
     
         14 . The method of  claim 1 , wherein the ISS is administered between about 1 day and about 4 weeks prior to antigen administration.  
     
     
         15 . The method of  claim 1 , wherein the ISS is administered between about 3 days and about 8 days prior to antigen administration.  
     
     
         16 . The method of  claim 1 , wherein the ISS is administered via a mucosal or systemic route.  
     
     
         17 . The method of  claim 16 , wherein the mucosal route is intranasal, ophthalmic, intratracheal, intravaginal or intrarectal.  
     
     
         18 . The method of  claim 16 , wherein the systemic route is intradermal, intramuscular, subcutaneous or intravenous.  
     
     
         19 . A method of immunizing a subject against a substance comprising administering to the subject an ISS at least one hour prior to exposing the subject to the substance.  
     
     
         20 . The method of  claim 19 , wherein the ISS comprises a CG, p(GC) or p(IC) DNA or RNA nucleotide sequence.  
     
     
         21 . The method of  claim 19 , wherein the ISS comprises the sequence 5′-rrcgyy-3′ (SEQ ID NO: 1), 5′-rycgyy-3′ (SEQ ID NO: 2), 5′-rrcgyycg-3′ (SEQ ID NO: 3) or 5′-rycgyycg-3′ (SEQ ID NO: 4).  
     
     
         22 . The method of  claim 21 , wherein the nucleotide sequence is selected from a group comprising AACGTT (SEQ ID NO: 5), AGCGTC (SEQ ID NO: 6), AGCGTT (SEQ ID NO: 7), GACGTT (SEQ ID NO: 8), GGCGTT (SEQ ID NO: 9), AACGTT (SEQ ID NO: 10), GTCGTT (SEQ ID NO: 24), AGCGTCCG (SEQ ID NO: 25), AACGTTCG (SEQ ID NO: 26), AGCGTTCG (SEQ ID NO: 27), GACGTTCG (SEQ ID NO: 28), GGCGTTCG (SEQ ID NO: 29), AACGTTCG (SEQ ID NO: 30), and AGCGTCCG (SEQ ID NO: 31).  
     
     
         23 . The method of  claim 19 , wherein the ISS is administered between about 6 hours and about 6 weeks prior to exposure to the substance.  
     
     
         24 . The method of  claim 19 , wherein the ISS is administered between about 1 day and about 4 weeks prior to exposure to the substance.  
     
     
         25 . The method of  claim 19 , wherein the ISS is administered between about 3 days and about 8 days prior to exposure to the substance.  
     
     
         26 . The method of  claim 19 , wherein the substance is an antigen or pathogen associated with an infectious disease, an allergen or a cancer.  
     
     
         27 . The method of  claim 26 , wherein the infectious disease is selected from the group comprising viral, bacterial, mycobacterial and parasitic disease.  
     
     
         28 . The method of  claim 19 , wherein the ISS is administered via a mucosal or systemic route.  
     
     
         29 . The method of  claim 28 , wherein the mucosal route is intranasal, ophthalmic, intratracheal, intravaginal or intrarectal.  
     
     
         30 . The method of  claim 28 , wherein the systemic route is intradermal, intramuscular, subcutaneous or intravenous.  
     
     
         31 . A method of eliciting IgG2 antibody production comprising administering to a subject an ISS at least one hour prior to administration of an antigen to the subject.  
     
     
         32 . The method of  claim 31 , wherein the ISS comprises a CG, p(GC) or p(IC) DNA or RNA nucleotide sequence.  
     
     
         33 . The method of  claim 31 , wherein the ISS comprises the sequence 5′-rrcgyy-3′ (SEQ ID NO: 1), 5′-rycgyy-3′ (SEQ ID NO: 2), 5′-rrcgyycg-3′ (SEQ ID NO: 3) or 5′-rycgyycg-3′ (SEQ ID NO: 4).  
     
     
         34 . The method of  claim 33 , wherein the nucleotide sequence is selected from a group comprising AACGTT (SEQ ID NO: 5), AGCGTC (SEQ ID NO: 6), AGCGTT (SEQ ID NO: 7), GACGTT (SEQ ID NO: 8), GGCGTT (SEQ ID NO: 9), AACGTC (SEQ ID NO: 10), GTCGTT (SEQ ID NO: 24), AGCGTCCG (SEQ ID NO: 25), AACGTTCG (SEQ ID NO: 26), AGCGTTCG (SEQ ID NO: 27), GACGTTCG (SEQ ID NO: 28), GGCGTTCG (SEQ ID NO: 29), AACGTTCG (SEQ ID NO: 30), and AGCGTCCG (SEQ ID NO: 31).  
     
     
         35 . The method of  claim 31 , wherein the ISS is administered between about 6 hours and about 6 weeks prior to antigen administration.  
     
     
         36 . The method of  claim 31 , wherein the ISS is administered between about 1 day and about 4 weeks prior to antigen administration.  
     
     
         37 . The method of  claim 31 , wherein the ISS is administered between about 3 days and about 8 days prior to antigen administration.  
     
     
         38 . The method of  claim 31 , wherein the antigen is associated with an infectious disease, an allergen or a cancer.  
     
     
         39 . The method of  claim 38 , wherein the infectious disease is selected from the group comprising viral, bacterial, mycobacterial and parasitic disease.  
     
     
         40 . The method of  claim 31 , wherein the ISS is administered via a mucosal or systemic route.  
     
     
         41 . The method of  claim 40 , wherein the mucosal route is intranasal, ophthalmic, intratracheal, intravaginal or intrarectal.  
     
     
         42 . The method of  claim 40 , wherein the systemic route is intradermal, intramuscular, subcutaneous or intravenous.

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