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EP0327180A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

Vaccine containing polypeptides derived from the envelope gene of human immunodeficiency virus type 1

Assignee: MicroGeneSys Inc
•
Filing: 1989-02-02
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Granted: —
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Expires: 2009-02-02
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Abstract

Abstract An Acquired Immunodeficiency Syndrome (AIDS) vaccine containing the Human Immunodeficiency Virus, Type-1 (HIV-1) envelope proteins is produced from cloned HIV-1 envelope genes in a baculovirus-inset cell vector system. The recombinant HIV-1 proteins are purified, assembled into particles and then adsorbed on an aluminum phosphate adjuvant. The resulting adsorbed recombinant HIV-1 virus envelope protein formulation is highly immunogenic in animals and elicits antibodies which bind to the HIV-1 virus envelope and neutralize the infectivity of the virus in in vitro tests.

Inventors

  • 👤 Gale E. Smith
  • 👤 Mark A. Cochran
  • 👤 Franklin Volvovitz

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-11-02 23:39
CPC Classifications
C; C12; C12N; C12N15/00; C12N15/09; C12N15/63; C12N15/79; C12N15/85; C12N15/86; A; A61; A61P; A61P31/00; A61P31/12; A61P31/14; A61P31/18; C07; C07K; C07K14/00; C07K14/005; A61K; A61K38/00; A61K39/00; C12N2710/00; C12N2710/00011; C12N2710/14011; C12N2710/14111; C12N2710/14141; C12N2710/14143; C12N2740/00; C12N2740/00011; C12N2740/10011; C12N2740/16011; C12N2740/16211; C12N2740/16222; C12N2740/16234

Claims Analysis

Total Claims: 43
Claim 1
Independent Claim 6 words
Undenatured or native HIV-1 envelope protein.
Claim 2
Dependent Claim 6 words
Undenatured or native HIV-1 envelope protein.
Claim 3
Dependent Claim 10 words
Recombinant undenatured or native HIV-1 envelope protein of Claim 1.
Claim 4
Dependent Claim 11 words
Substantially biologically pure HIV-1 envelope protein in accordance with Claim 1.
Claim 5
Dependent Claim 22 words
Substantially biologically pure HIV-1 envelope protein in accordance with Claim 1 of a purity and quality useful as a vaccine for humans.
Claim 6
Dependent Claim 10 words
Substantially biologically pure gp160 protein in accordance with Claim 1.
Claim 7
Dependent Claim 22 words
Recombinant substantially pure HIV-1 envelope protein in accordance with Claim 1 of a purity and quality useful as a vaccine for humans.
Claim 8
Dependent Claim 17 words
A substantially non-pyrogenic vaccine composi­tion containing a protein in accordance with Claim 1 together with an adjuvant.
Claim 9
Dependent Claim 14 words
A composition in accordance with Claim 7 wherein said adjuvant is particle-form aluminum phos­phate.
Claim 10
Dependent Claim 14 words
A composition in accordance with Claim 7 wherein said adjuvant is particle-form aluminum hydrox­ide.
Claim 11
Dependent Claim 27 words
A composition for the treatment of ac­quired immunodeficiency syndrome (AIDS) compris­ ing a minor amount of a protein in accordance with Claim 1 together with a carrier.
Claim 12
Dependent Claim 9 words
gp160 HIV-1 envelope protein in accordance with Claim 1.
Claim 13
Dependent Claim 10 words
Recombinant gp160 HIV-1 envelope protein in accordance with Claim 1.
Claim 14
Dependent Claim 14 words
A recombinant DNA molecule for expressing HIV-1 envelope protein in accordance with Claim 1.
Claim 15
Dependent Claim 17 words
A DNA molecule of Figs. 4a-4k herein for ex­pressing HIV-1 envelope protein in accordance with Claim 1.
Claim 16
Dependent Claim 17 words
A recombinant DNA molecule containing the DNA sequence for expressing the HIV-1 envelope protein of Claim 1.
Claim 17
Dependent Claim 19 words
A recombinant DNA molecule in accordance with Claim 15 containing a DNA sequence for express­ing gp160 HIV-1 envelope protein.
Claim 18
Dependent Claim 8 words
A DNA molecule in accordance with AC3046 herein.
Claim 19
Dependent Claim 8 words
A DNA molecule in accordance with AC3046 herein.
Claim 20
Dependent Claim 22 words
Substantially biologically pure undenatured or native HIV-1 envelope protein in accordance with Claim 1 recovered after expression in a host insect cell.
Claim 21
Dependent Claim 15 words
Substantially biologically pure undenatured or native gp160 HIV-1 envelope protein in accor­dance with Claim 18.
Claim 22
Dependent Claim 19 words
Recombinant substantially biologically pure undenatured or native HIV-1 envelope protein expressed by Ac3046 herein in accordance with Claim 18.
Claim 23
Dependent Claim 27 words
The recombinant DNA molecule Ac3046 herein in accordance with Claim 17 for the expression of undenatured or native gp160 envelope protein of HIV-1 in an insect cell.
Claim 24
Dependent Claim 28 words
A method of treating a human patient suffering from AIDS which comprises administering to the patient a therapeutically effective amount of a protein in accordance with Claim 1.
Claim 25
Dependent Claim 26 words
A method for preventing AIDS in a human which comprises administering to said human an effec­tive prophylactic amount of a protein in accor­dance with Claim 4.
Claim 26
Independent Claim 56 words
A method of recovering and purifying recombinant HIV-1 envelope protein material expressed in a cell which comprises after expression of said protein material recovering and washing the cells, lysing the cells, subjecting the result­ing lysate to a lectin affinity chromatography followed by gel filtration chromatography and dialysis and recovering the resulting purified HIV-1 envelope protein material.
Claim 27
Independent Claim 56 words
A method of recovering and purifying recombinant HIV-1 envelope protein material expressed in a cell which comprises after expression of said protein material recovering and washing the cells, lysing the cells, subjecting the result­ing lysate to a lectin affinity chromatography followed by gel filtration chromatography and dialysis and recovering the resulting purified HIV-1 envelope protein material.
Claim 28
Dependent Claim 42 words
A method in accordance with Claim 24 wherein said cells containing the to-be-recovered HIV-1 envelope protein material therein are subjected to washing in a buffer solution containing 50 nM Tris buffer at a pH 7.5 and 1nM EDTA and 1% Triton X-100.
Claim 29
Dependent Claim 36 words
A method in accordance with Claim 24 wherein cells lysis is carried out by sonication in a 50 nM Tris buffer at a pH in the range about 8.0-­8.5 and 4% deoxycholate and 1% beta mercapto­ethanol.
Claim 30
Dependent Claim 20 words
A method in accordance with Claim 24 wherein said gel filtration is carried out to a column containing Sephacryl resin.
Claim 31
Dependent Claim 18 words
A method in accordance with Claim 24 wherein said lectin affinity chromatography is carried out employing lentil lectin.
Claim 32
Dependent Claim 28 words
A method in accordance with Claim 24 wherein the resulting recovered purified HIV-1 envelope protein material is agglomerated or assembled into particles of about ≧ 2,000,000 molecular weight.
Claim 33
Dependent Claim 15 words
A method in accordance with Claim 24 wherein said HIV-1 envelope protein material is gp160.
Claim 34
Dependent Claim 30 words
A method in accordance with Claim 24 wherein said HIV-1 envelope protein material is gp160 which is agglomerated or assembled into parti­cles having a molecular weight of about ≧ 2,000,000.
Claim 35
Dependent Claim 25 words
Undenatured or native HIV-1 envelope protein material in accordance with Claim 1 in finely divided particle-form and having a molecular weight of about ≧ 2,000,000.
Claim 36
Dependent Claim 18 words
Undenatured or native HIV-1 envelope protein material in accordance with Claim 32 wherein said protein material is gp160.
Claim 37
Dependent Claim 22 words
Undenatured or native HIV-1 envelope protein material in accordance with Claim 1 having a substantially spherical particle-form in the range about 30-100nM.
Claim 38
Dependent Claim 18 words
Undenatured or native HIV-1 envelope protein material in accordance with Claim 1 wherein said protein material is gp160.
Claim 39
Dependent Claim 30 words
An immunogen composition comprising undenatured or native HIV-1 envelope protein material com­plexed with alum wherein said protein material is present therein at a concentration of about 40µg/ml of said composition.
Claim 40
Dependent Claim 30 words
An immunogen composition comprising undenatured or native HIV-1 envelope protein material com­plexed with alum wherein said protein material is present therein at a concentration of about 40µg/ml of said composition.
Claim 41
Independent Claim 24 words
A method of complexing HIV-1 envelope protein material with alum wherein said protein is complexed with said alumn at a pH of about 7.0-­7.2.
Claim 42
Independent Claim 24 words
A method of complexing HIV-1 envelope protein material with alum wherein said protein is complexed with said alumn at a pH of about 7.0-­7.2.
Claim 43
Dependent Claim 15 words
A method in accordance with Claim 37 wherein said HIV-1 envelope protein material is gp160.

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