Single dose non-adjuvanted cutaneous tetanus vaccine and uses thereof

Abstract

A method for preventing or treating tetanus infection in a subject, comprising administering a non-adjuvanted tetanus toxoid vaccine to the skin. The vaccine can be delivered by intradermal injection or microneedle patch and does not require cold storage.

What is claimed is: 
     
         1 . A microneedle patch containing a non-adjuvanted tetanus toxoid vaccine. 
     
     
         2 . The microneedle patch of  claim 1 , wherein the patch is loaded with commercially-available non-adjuvanted tetanus toxoid monobulk that is concentrated at least five times its original concentration. 
     
     
         3 . The microneedle patch of  claim 2 , wherein the non-adjuvanted tetanus toxoid comprises 3% polyvinyl alcohol and 10% sucrose as excipients. 
     
     
         4 . A method for treating tetanus infection in a subject, comprising administering a non-adjuvanted tetanus toxoid vaccine to the skin by applying the patch of  claim 1 . 
     
     
         5 . The method of  claim 4 , wherein the vaccine does not require cold storage or cold transport. 
     
     
         6 . The method of  claim 4 , wherein the subject is pregnant. 
     
     
         7 . The method of  claim 4 , further comprising:
 administering a non-adjuvanted tetanus toxoid vaccine by placing a microneedle patch containing the vaccine on the skin of the subject;   holding the patch in place to allow the vaccine to dissolve into the skin.   
     
     
         8 . The method of  claim 4 , wherein the microneedles of the patch penetrate the skin and the patch is held in place for at least 10 minutes. 
     
     
         9 . The method of  claim 4 , wherein at least five-fold higher level of tetanus toxoid-specific antibodies are induced in non-pregnant subjects than for intramuscular administration in non-pregnant subjects. 
     
     
         10 . The method of  claim 4 , wherein at least two-fold higher level of tetanus toxoid-specific antibodies are induced in pregnant subjects than for intramuscular administration in pregnant subjects. 
     
     
         11 . The method of  claim 4 , wherein at least a six-fold higher level of tetanus toxoid-specific antibodies IgG2a are induced in a pregnant subject as compared to intramuscular administration in a non-pregnant subject. 
     
     
         12 . The method of  claim 4 , wherein at least a ten-fold increase in antibody levels is induced at week 3 as compared to intramuscular administration. 
     
     
         13 . The method of  claim 4 , wherein the induced ratio IgG1/IgG2a is lower as compared to intramuscular administration. 
     
     
         14 . The method of  claim 4 , wherein the patch is loaded with commercially-available non-adjuvanted tetanus toxoid monobulk that is concentrated at least five times its original concentration. 
     
     
         15 . The method of  claim 4 , wherein the non-adjuvanted tetanus toxoid comprises 3% polyvinyl alcohol and 10% sucrose as excipients.