Patent EA-002390-B1 (EA)
Title: Polyenv vaccine aganist a hiv human, method for making humoral and/or cellular immune response in mammals upon hiv and bi-functional plasmid
Inventor: HURWITZ JULIA
IPC: C12N/
Filed: 1997-01-23
Abstract: 1. A polyenv vaccine comprising at least 4 to about 10,000 different recombinant vaccinia viruses, each of them expresses a different variant of an env variant (EV) variant of a human immunodeficiency virus (HIV), wherein said EV nucleotide encodes both variable and constant regions of said envelope protein variant and said immunogenic composition is capable of eliciting at least one of a cellular and a humoral immmune response in a mammal against an HIV strain. 2. The polyenv according to claim 1, comprising from 10 to 100 recombinant viruses comprising different EV variants of HIV. 3. The polyenv according to claim 1, wherein the recombinant viruses are selected from the group consisting of vaccinia virus, canary pox virus, adenovirus and adeno-assosiated virus (AAV). 4. The polyenv according to claim 1, wherein different EV variant of HIV comprises gp120 and an oligomerization domain of gp41 sufficient to permit oligomerization of env proteins. 5. The polyenv according to claim 4, wherein different EV variants of HIV encode nucleotide, comprising comprises a KpnI-BsmI restriction fragment.  6. The polyenv according to claim 1, wherein the EV nucleotide sequence is isolated from patients infected with an HIV virus from a geographically restricted area or from patients infected with an HIV virus from different clades. 7. The polyenv according to claim 1, wherein the vaccine further comprises envelope protein variants expressed by the recombinant viruses. 8. The polyenv according to claim 1, wherein said immunogenic composition further comprises at least one of a pharmaceutically acceptable carrier, an adjuvant and an antiviral chemotherapeutic compound. 9. A method for making a humoral and/or cellular immune response in a mammal against a HIV human, comprising administering a mammal a vaccine in an effective amount, wherein the polyenv vaccine is used as a vaccine according to any of claims 1 to 8. 10. The method according to claim 9, wherein if a recombinant virus is a vaccinia virus then the polyenv virus is administered subcutaneously. 11. The method according to claim 9, wherein two polyenv vaccines are administered according to any of claims 1 to 8, in which the recombinant viruses are of a different species. 12. The method according to claim 9, wherein further comprising priming or boosting a humoral and/or cellular immune response by administering (a) an effective amount of at least one recombinant HIV env protein and/or (b) an effective amount of at least one DNA vector that codes on expression for a recombinant HIV env protein, wherein the DNA vector may be administered before, after or concurrently with the recombinant HIV env protein. 13. The method according to claim 9, wherein prior to administering the recombinant HIV env protein is mixed with an adjuvant. 14. The method according to claim 9, wherein the recombinant HIV evn protein is administered intramuscularly. 15. The method according to claim 9, wherein the recombinant HIV evn protein is mixed with an adjuvant and administered intramuscularly. 16. The method according to claim 9, wherein the DNA vector is administered with a gene gun. 17. A bi-functional plasmid used for producing recombinant viruses contained in the vaccine composition according to claim 1, comprising a xenogeneic gene, encoding a different envelope protein variant (EPV) of a immunoedeficiency virus (HIV) envelope protein, wherein the EPV contains both variable and constant regions, wherein said gene is under the control of expression sequences of two types, namely, the sequence is a cytomegalovirus immediate early (CMV) promoter and the sequence of a vaccinia virus early promoter and/or the sequence of a vaccinia virus late promoter.