Claims for Patent: 5,643,565

Summary for Patent: 5,643,565

Title:	Human IL-2 as a vaccine adjuvant
Abstract:	Methods for enhancing the immune response to vaccination in animals, including humans, comprise administering interleukin-2 (IL-2) as part of the vaccination regimen, preferably for 5 to 14 days post-vaccination. In addition, compositions for enhancing the immune response of an animal to a vaccine employ IL-2 as an active ingredient, preferably human IL-2.
Inventor(s):	Doyle; Michael V. (Oakland, CA), Newell; Arthur D. (Orinda, CA), Nunberg; Jack H. (Oakland, CA), White; Thomas J. (Oakland, CA)
Assignee:	Chiron Corporation (Emeryville, CA)
Application Number:	08/448,884
Patent Claims:	1. A composition for enhancing the immune response of an animal to a rabies vaccine, which composition comprises interleukin 2 and a rabies vaccine. 2. The composition of claim 1 wherein the IL-2 is human IL-2. 3. The composition of claim 2 wherein the human IL-2 is a water-soluble form of human IL-2. 4. The composition of claim 3 wherein the human IL-2 is PEGylated human IL-2. 5. The composition of claim 3 wherein the human IL-2 is succinylated human IL-2. 6. The composition of claim 2 wherein the human IL-2 is des-alanyl-rIL-2.sub.ser125. 7. The composition of claim 1 wherein the IL-2 is in the form of a continuous release formulation. 8. The composition of claim 1 wherein the IL-2 is in the form of a single sustained action formulation. 9. A composition for enhancing the immune response of a human to a rabies vaccine, which composition comprises human interleukin-2 (hIL-2) and a rabies vaccine. 10. The composition of claim 9 wherein the hIL-2 is a water-soluble form of hIL-2. 11. The composition of claim 10 wherein the hIL-2 is PEGylated hIL-2 or succinylated hIL-2. 12. The composition of claim 9 wherein the hIL-2 is des-alanyl-rIL-2.sub.ser125. 13. The composition of claim 9 wherein the IL-2 is in the form of a continuous release formulation. 14. The composition of claim 9 wherein the IL-2 is in the form of a single sustained action formulation. 15. A method for enhancing the immune response of an animal to a rabies vaccine, comprising: administering an effective amount of interleukin-2 (IL-2) and rabies vaccine to the animal as part of a vaccination regimen. 16. The method of claim 15 wherein said IL-2 is human IL-2. 17. The method of claim 16 wherein the human IL-2 is des-alanyl-rIL-2.sub.ser125. 18. The method of claim 17 wherein the human IL-2 is a water soluble form of human IL-2. 19. The method of claim 18 wherein the water soluble form of human IL-2 is PEGylated human IL-2 or succinylated human IL-2. 20. The method of claim 15 wherein the IL-2 is in the form of a continuous release formulation. 21. The method of claim 15 wherein the IL-2 is in the form of a single sustained action formulation. 22. The method of claim 15 wherein the IL-2 is administered subsequent to the administration of the vaccine. 23. The method of claim 20 wherein the IL-2 is administered continuously at a rate of above about 10.sup.3 and below about 10.sup.6 units/kg/day for about 5 to 30 days post-vaccination. 24. A method for enhancing the immune response in accordance with claim 16 wherein the animal is a human. 25. The method of claim 24 wherein the hIL-2 is a water-soluble form of hIL-2. 26. The method of claim 25 wherein the hIL-2 is PEGylated or succinylated IL-2. 27. The method of claim 24 wherein the hIL-2 is des-alanyl-rIL-2.sub.ser125. 28. The method of claim 24 wherein the hIL-2 is in the form of a continuous release formulation. 29. The method of claim 24 wherein the hIL-2 is in the form of a single sustained action formulation.

Details for Patent 5,643,565

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bavarian Nordic A/s	RABAVERT	rabies vaccine	For Injection	103334	10/20/1997		2014-07-01
Sanofi Pasteur Sa	IMOVAX RABIES	rabies vaccine	For Injection	103931	02/04/2000		2014-07-01