Methods of using nucleic acid vector-lipid complexes

• US 7,741,300 B2
• Filed: 12/27/2005
• Issued: 06/22/2010
• Est. Priority Date: 06/25/1998
• Status: Expired due to Fees

• Current Assignee: National Jewish Medical and Research Center
• Original Assignee: National Jewish Medical and Research Center
• Inventors: Schwarze, Jurgen Karl Johannes, Dow, Steven W., Elmslie, Robyn E., Gelfand, Erwin W.
• Primary Examiner(s): WEHBE, ANNE MARIE SABRINA
• Application Number:
  US11/320,019
• Publication Number:
  US 20060223769A1
• Time in Patent Office: 1,638 Days
• Field of Search: 514/44, 435/458, 435/320.1
• US Class Current: 514/44.00R
• CPC Class Codes: A61K 2039/5152 Tumor cells
• CPC Class Codes: A61K 2039/53 DNA (RNA) vaccination
• CPC Class Codes: A61K 2039/55555 Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
• CPC Class Codes: A61K 2039/57 characterised by the type of response, e.g. Th1, Th2
• CPC Class Codes: A61K 2239/31 characterized by the route of administration
• CPC Class Codes: A61K 2239/38 characterised by the dose, timing or administration schedule
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 38/20 Interleukins [IL]
• CPC Class Codes: A61K 38/2013 IL-2
• CPC Class Codes: A61K 38/208 IL-12
• CPC Class Codes: A61K 38/2086 IL-13 to IL-16
• CPC Class Codes: A61K 39/0011 Cancer antigens
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61K 39/155 Paramyxoviridae, e.g. parainfluenza virus
• CPC Class Codes: A61K 39/35 Allergens
• CPC Class Codes: A61K 39/39 characterised by the immunostimulating additives, e.g. chemical adjuvants
• CPC Class Codes: A61K 39/4615 Dendritic cells
• CPC Class Codes: A61K 39/4622 Antigen presenting cells
• CPC Class Codes: A61K 39/4644 Cancer antigens
• CPC Class Codes: A61K 39/464499 Undefined tumor antigens, e.g. tumor lysate or antigens targeted by cells isolated from tumor
• CPC Class Codes: A61K 39/464838 : Viral antigens
• CPC Class Codes: A61K 47/6911 : the form being a liposome
• CPC Class Codes: A61K 48/00 : Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
• CPC Class Codes: A61K 9/1272 : with substantial amounts of non-phosphatidyl, i.e. non-acylglycerophosphate, surfactants as bilayer-forming substances, e.g. cationic lipids with cholesterol as the only non-phosphatidyl surfactant A61K9/127; lipids as modifying agent A61K47/543
• CPC Class Codes: A61P 37/00 : Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/02 : Immunomodulators
• CPC Class Codes: A61P 37/04 : Immunostimulants
• CPC Class Codes: A61P 39/00 : General protective or antinoxious agents
• CPC Class Codes: C12N 2760/18834 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

Abstract

This invention relates to a vaccine and a method for immune activation which is effective for eliciting both a systemic, non-antigen specific immune response and a strong antigen-specific immune response in a mammal. The method is particularly effective for protecting a mammal from a disease including cancer, a disease associated with allergic inflammation, an infectious disease, or a condition associated with a deleterious activity of a self-antigen. Also disclosed are therapeutic compositions useful in such a method.

Claims

1. A method for eliciting a systemic, non-antigen-specific immune response in a mammal, comprising administering to said mammal an amount of a composition effective to elicit said immune response, wherein said composition comprises:

a. a cationic liposome delivery vehicle; and

b. an isolated nucleic acid molecule comprising an isolated bacterially-derived nucleic acid vector without a gene insert or a fragment thereof.

2. The method of claim 1, wherein said liposome delivery vehicle comprises lipids selected from the group consisting of multilamellar vesicle lipids and extruded lipids.

3. The method of claim 1, wherein said liposome delivery vehicle comprises multilamellar vesicle lipids.

4. The method of claim 1, wherein said liposome delivery vehicle comprises pairs of lipids selected from the group consisting of DOTMA and cholesterol;

DOTAP and cholesterol;

DOTIM and cholesterol, and DDAB and cholesterol.

5. The method of claim 1, wherein said liposome delivery vehicle comprises DOTAP and cholesterol.

6. The method of claim 1, wherein said composition further comprises a pharmaceutically acceptable excipient.

7. The method of claim 6, wherein said excipient comprises a non-ionic diluent.

8. The method of claim 7, wherein said excipient is 5 percent dextrose in water.

9. The method of claim 1, wherein said composition has a nucleic acid to lipid ratio of from about 1:

1 to about 1;

64.