Liposome-containing intranasal vaccine formulation

• US 5,756,104 A
• Filed: 06/05/1995
• Issued: 05/26/1998
• Est. Priority Date: 01/29/1990
• Status: Expired due to Term

• Current Assignee: Duphar International Research B.V. (Abbott Laboratories)
• Original Assignee: Duphar International Research B.V. (Abbott Laboratories)
• Inventors: de Haan, Aalzen, Geerligs, Harmen J., Wilschut, Jan C.
• Primary Examiner(s): PARR, MARGARET M
• Application Number:
  US08/461,768
• Time in Patent Office: 1,086 Days
• Field of Search: 424/206.1, 424/193.1, 424/450, 424/283.1, 424/196.11, 424/197.11, 424/201.1, 424/202.1, 424/203.1, 424/212.1
• US Class Current: 424/206.1
• CPC Class Codes: A61K 2039/5252 inactivated (killed)
• CPC Class Codes: A61K 2039/543 intranasal
• CPC Class Codes: A61K 2039/55555 Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61K 39/145 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: A61K 39/165 Mumps or measles virus
• CPC Class Codes: A61K 39/39 characterised by the immunostimulating additives, e.g. chemical adjuvants
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61K 9/0073 Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M
• CPC Class Codes: A61K 9/127 Liposomes
• CPC Class Codes: A61P 31/16 for influenza or rhinoviruses
• CPC Class Codes: B82Y 5/00 Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
• CPC Class Codes: C12N 2760/16134 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2760/18434 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

Abstract

The present invention relates to a vaccine formulation for intranasal or inhalation administration, and to the preparation thereof, which formulation contains antigenic material freely mixed with empty liposomes.

Claims

1. A vaccine formulation for intranasal or inhalation administration, characterized in that the vaccine formulation comprises antigenic material and empty liposomes having a net negative surface charge, in which the antigenic material and the liposomes are substantially unassociated, and wherein the antigenic material is derived from at least one organism which is capable of infecting the respiratory tract.

2. The vaccine as claimed in claim 1, characterized in that the antigenic material consists of a combination of different antigens.

3. The vaccine as claimed in claim 1, characterized in that the mass ratio of liposomal material to antigenic material is at least 5:

1.

4. The vaccine as claimed in claim 1, characterized in that the liposomes comprise at least one phospholipid.

5. The vaccine as claimed in claim 4, characterized in that the phospholipid is phosphatidylcholine.

6. The vaccine as claimed in claim 4, wherein the vaccine additionally comprises a sterol.

7. The vaccine as claimed in claim 6, characterized in that the sterol is cholesterol.

8. The vaccine as claimed in claim 1, characterized in that at least one member selected from the group consisting of dicetylphosphate, phosphatidic acid and phosphatidylglycerol is present as the charge-determining component.

9. The vaccine formulation of claim 1, wherein the antigenic material comprises the surface antigens of influenza virus.

10. The vaccine formulation of claim 1, wherein the antigenic material is derived from measles virus.

11. The method of preparing a vaccine formulation as claimed in claim 1, characterized in that dried lipid is dispersed in an aqueous medium and the resulting mixture containing liposomes is mixed with an antigen-containing solution.