Vaccine and method of use

Abstract

A method of administering a vaccine to females to prevent or treat infections associated with pathogens which cause sexually transmitted diseases is described. The vaccine comprises one or more antigens for the prevention or treatment of sexually transmitted diseases, for example an HSV glycoprotein D or an immunological fragment thereof, and an adjuvant, especially a TH-1 inducing adjuvant. The use of the vaccine components for the formulation of a vaccine composition for the prevention or treatment of sexually transmitted diseases in female subjects is also described.

1 - 19 . (canceled)  
   
   
       20 . A method for preventing a sexually transmitted disease in an HSV1−/2− female human subject, which method comprises administering an effective amount of a vaccine formulation comprising an adjuvant and an antigen comprising HSV-1 glycoprotein D, HSV-2 gluycoprotein D, or an immunological fragment thereof.  
   
   
       21 . The method according to  claim 21  in which the adjuvant is a TH-1 inducing adjuvant.  
   
   
       22 . The method according to  claim 21  in which the HSV-2 glycoprotein D is a truncated glycoprotein.  
   
   
       23 . The method according to  claim 22  in which the truncated glycoprotein is HSV gD2 and is devoid of the C-terminal anchor region (gD2t).  
   
   
       24 . The method according to  claim 21  wherein the antigen is formulated with a suitable carrier.  
   
   
       25 . The method according to  claim 22  wherein the carrier is aluminium hydroxide, aluminium phosphate or an oil in water emulsion.  
   
   
       26 . The method according to  claim 21  wherein the adjuvant is the TH-1 inducing adjuvant 3D-MPL.  
   
   
       27 . The method according to  claim 26  wherein particles of 3D-MPL are small enough to be sterile filtered through a 0.22 micron membrane.  
   
   
       28 . The method according to  claim 21  wherein the prevents genital herpes infections.  
   
   
       29 . The method according to  claim 20  in which the vaccine formulation comprises gD2t (1-1000 μg), 3D-MPL (10-200 μg) and an aluminium salt (100-1000 μg).  
   
   
       30 . The method according to  claim 20  in which the vaccine formulation comprises gD2t (20 μg), 3D-MPL (50 μg) and alum (500 μg).  
   
   
       31 . The method according to  claim 21  wherein the vaccine formulation is administered to female subjects at intervals of 0, 1 and 6 months.  
   
   
       32 . The method according to  claim 21  wherein the vaccine formulation is administered intramuscularly.