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 . A method of treating a female human subject suffering from or susceptible to one or more sexually transmitted diseases (STDs), which method comprises administering to a female subject in need thereof an effective amount of a vaccine formulation comprising one or more antigens derived from or associated with an STD-causing pathogen and an adjuvant.  
     
     
         2 . The method according to  claim 1  in which the adjuvant is a TH-1 inducing adjuvant.  
     
     
         3 . The method according to  claim 1  in which the said one or more antigens includes HSV glycoprotein D or an immunological fragment thereof.  
     
     
         4 . The method according to  claim 3  in which the HSV-2 glycoprotein D is a truncated glycoprotein.  
     
     
         5 . The method according to  claim 4  in which the truncated glycoprotein is HSV gD2 and is devoid of the C-terminal anchor region (gD2t).  
     
     
         6 . The method according to  claim 1  in which the said one or more antigens includes an antigen derived from or associated with HPV.  
     
     
         7 . The method according to  claim 1  in which the said one or more antigens includes an antigen derived from or associated with Chlamydia.  
     
     
         8 . The method according to  claim 1  in which the said one or more antigens includes an antigen derived from or associated with  Neiserria gonnorhea.    
     
     
         9 . The method according to  claim 1  in which the said one or more antigens includes an antigen derived from or associated with  Treponema pallidum  (syphilis) or  Haemophilus ducreyi  (chancroid).  
     
     
         10 . The method according to any one of claims  1 - 9  wherein the antigen or combination of antigens is formulated with a suitable carrier.  
     
     
         11 . The method according to  claim 10  wherein the carrier is aluminium hydroxide (alum), aluminium phosphate or an oil in water emulsion.  
     
     
         12 . The method according to  claim 11  wherein the adjuvant is the TH-1 inducing adjuvant 3D-MPL.  
     
     
         13 . The method according to  claim 12  in which the particles of 3D-MPL are small enough to be sterile filtered through a 0.22 micron membrane.  
     
     
         14 . The method according to  claim 1  wherein the vaccine is used to immunise or treat female subjects at risk of contracting herpes simplex infections.  
     
     
         15 . The method according to  claim 14  wherein the vaccine is used to treat or prevent genital herpes infections.  
     
     
         16 . The method according to  claim 14  or  15  in which the vaccine formulation comprises gD2t (1-1000 μg), 3D-MPL (10-200 μg) and an aluminium salt (100-1000 μg).  
     
     
         17 . The method according to  claim 16  in which the vaccine formulation comprises gD2t (20 μg), 3D-MPL (50 μg) and alum (500 μg).  
     
     
         18 . The method according to  claim 1  wherein the vaccine formulation is administered to, or manufactured for administration to, female subjects at intervals of 0, 1 and 6 months.  
     
     
         19 . The method according to  claim 1  wherein the vaccine formulation is administered intramuscularly.