Vaccination of immunocompromised subjects

Abstract

Disclosed herein are methods for enhancing immune responses to a vaccine in immunocompromised individuals, including those receiving a statin therapy. Related products are also provided.

1 : A method for enhancing an immune response in a subject comprising administering a vaccine, wherein the vaccine comprises:
 (a) an adjuvant;   (b) a high-dose antigen; or   a combination of (a) and (b); and   wherein the subject is under the age of 65 and on a statin therapy.   
     
     
         2 : The method of  claim 1 , wherein the adjuvant is an aluminum salt adjuvant or an oil-in-water emulsion adjuvant. 
     
     
         3 : The method of  claim 2 , wherein the oil-in-water emulsion adjuvant comprises squalene. 
     
     
         4 : The method of  claim 2 , wherein the oil-in-water adjuvant comprises squalene, polysorbate 80, and sorbitan trioleate. 
     
     
         5 : The method of  claim 1 , wherein the vaccine comprises between a ⅛ and a ten-fold the amount of a standard dose antigen. 
     
     
         6 : The method of  claim 1 , wherein the vaccine is an influenza vaccine. 
     
     
         7 : The method of  claim 5 , wherein the influenza vaccine comprises between about 30 μg and about 150 μg of antigen per strain. 
     
     
         8 : The method of  claim 6 , wherein the influenza vaccine comprises an H1N1 strain, an H3N2 strain, a B strain, or any combination thereof. 
     
     
         9 : The method of  claim 1 , wherein the vaccine does not contain an oil-in-water emulsion adjuvant. 
     
     
         10 : The method of  claim 1 , wherein the subject is:
 a) currently on a statin therapy;   b) not currently on a statin therapy but was on a statin therapy which terminated within the last 3 months; or   c) not currently on a statin therapy but is scheduled to be on a statin therapy in the next 3 months.   
     
     
         11 : The method of  claim 1 , wherein the subject is
 between the age of 60 and 64.   
     
     
         12 : The method of  claim 1 , wherein the subject has a disease or disorder associated with impaired immunity. 
     
     
         13 : The method of  claim 1 , wherein the statin therapy comprises a synthetic statin, a non-synthetic statin, or a combination thereof. 
     
     
         14 : The method of  claim 13 , wherein the statin therapy comprises a synthetic statin selected from the group consisting of: Fluvastatin, Atorvastatin, Cerivastatin, Rosuvastatin and Pitavastatin. 
     
     
         15 : The method of  claim 3 , wherein the oil-in-water emulsion adjuvant further comprises a surfactant. 
     
     
         16 : The method of  claim 4 , wherein the oil-in-water adjuvant comprises about 4.3% squalene, about 0.5% polysorbate 80 and about 0.48% sorbitan trioleate by weight. 
     
     
         17 : The method of  claim 5 , wherein the vaccine comprises between a two-fold and a ten-fold the amount of a standard dose antigen. 
     
     
         18 : The method of  claim 6 , wherein the influenza vaccine is a multivalent influenza vaccine. 
     
     
         19 : The method of  claim 7 , wherein the influenza vaccine comprises about 60 μg of antigen per strain. 
     
     
         20 : The method of  claim 6 , wherein the influenza vaccine comprises between about 30 μg and about 150 μg of antigen per strain. 
     
     
         21 : The method of  claim 20 , wherein the influenza vaccine comprises about 60 μg of antigen per strain. 
     
     
         22 : The method of  claim 7 , wherein the influenza vaccine comprises an H1N1 strain, an H3N2 strain, a B strain, or any combination thereof. 
     
     
         23 : The method of  claim 10 , wherein the subject has been on the statin therapy for at least 1 week. 
     
     
         24 : The method of  claim 23 , wherein the subject has been on the statin therapy for at least 2 weeks. 
     
     
         25 : The method of  claim 24 , wherein the subject has been on the statin therapy for at least 3 weeks. 
     
     
         26 : The method of  claim 25 , wherein the subject has been on the statin therapy for at least 4 weeks or longer. 
     
     
         27 : The method of  claim 13 , wherein the statin therapy comprises a statin selected from the group consisting of: Pravastatin, Simvastatin, Lovastatin and Mevastatin, Fluvastatin, Atorvastatin, Cerivastatin, Rosuvastatin and Pitavastatin.