Vaccine for transcutaneous immunization
View Patent ↗A vaccine delivered by transcutaneous immunization provides an effective treatment against infections by pathogens such as, for example, enterotoxigenic Escherichia coli (ETEC) and/or for symptoms of diarrheal disease caused thereby. For example, one, two, three, four, five or more antigens derived from ETEC and capable of inducing an antigen-specific immune response (e.g., toxins, colonization or virulence factors) and one or more optional adjuvant (e.g., whole bacterial ADP-ribosylating exotoxins, B subunits or toxoids thereof, detoxified mutants and derivatives thereof) are used to manufacture vaccines or to induce systemic and/or mucosal immunity.
1. A method of preventing traveler's diarrhea in a human that is to be subjected to exposure to pathogens causing traveler's diarrhea comprising applying a vaccine transcutaneously to the skin of the human, prior to exposure to pathogens causing traveler's diarrhea, wherein the vaccine comprises an effective amount of heat-labile enterotoxin of E. coli (LT) to prevent traveler's diarrhea.
2. A method of preventing traveler's diarrhea in a human that is to be subjected to exposure to pathogens causing traveler's diarrhea comprising applying a vaccine transcutaneously to the skin of the human, prior to exposure to pathogens causing traveler's diarrhea, wherein the vaccine comprises an effective amount of heat-labile enterotoxin of E. coli (LT) to treat traveler's diarrhea.
3. The method of claim 1 or 2 , wherein the vaccine comprises LT and an adjuvant.
4. The method of claim 3 , wherein the adjuvant is an ADP-ribosylating exotoxin or a derivative thereof having adjuvant activity.
5. The method of claim 1 or 2 , wherein the vaccine comprises LT and an E. coli colonization factor antigen (CFA).
6. The method of claim 5 , wherein the E. coli colonization factor antigen is selected from the group consisting of CFA/I, CS1, CS2, CS 4, CS5, CS6, CS17 and PCF 0166.
7. The method of claim 1 , wherein the vaccine comprises LT and heat stable enterotoxin of E. coli (ST).
8. The method of claim 7 , wherein the vaccine comprises a carrier or an excipient.
9. The method of claim 7 , wherein LT is conjugated to ST.
10. The method of claim 1 , wherein the method comprises pretreating the skin prior to administering the vaccine.
11. The method of claim 10 , wherein pretreating comprises chemical penetration enhancement, physical penetration enhancement, or both.
12. The method of claim 1 or 2 , wherein the vaccine is applied using a patch.
13. The method of claim 12 wherein the vaccine comprises a carrier or an excipient.
14. The method of claim 1 , wherein LT is genetically detoxified.
15. The method of claim 1 or 2 , wherein LT is a mutant form of the enterotoxin.
16. The method of claim 1 or 2 , wherein LT is both an antigen and an adjuvant.
17. The method of claim 16 , wherein LT is a mutant form of the enterotoxin.