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Pharmaceutical Composition Comprising An Antigen

Inactive Publication Date: 2009-04-23
FLEITMANN JULIA KRISTINA +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0013]It is the object of the present invention to provide a pharmaceutical composition which allows an effective delivery to a target cell especially to the cellular immune system.
[0018]It has surprisingly turned out that the combination of the selected immunostimulating substance according to the present invention and the polycationic polymer with an antigen leads to a synergistic immunomodulating effect for a given antigen preparation. Indeed, it turned out that the effect of an immunostimulating substance selected according to the present invention alone with the antigen has—for itself—even a lower effect than administering the antigen with the polycationic polymer alone.

Problems solved by technology

Although this notion is valid for a whole panel of diseases including tuberculosis, diphteria, pertussis, measles and tetanus, there are no effective vaccines for numerous ailments including most viral infections, such as AIDS, and other illnesses including malaria, or even cancer.
The main problem in the field of vaccines is that traditional vaccines (and / or the immune modulating compounds contained within these preparations) are designed to induce high levels of antibodies (Harlow et al, Cold Spring Harbor: Cold Spring Harbor Laboratory, (1988)).
Unfortunately, antibodies on their own are not effective in preventing many diseases including most illnesses caused by viruses, intracellular bacteria, or certain parasites.
In addition, these vaccines likely will not be effective in cancer.
Whilst numerous studies have confirmed the growth promoting effect of HGH, relatively few reports address a possible interaction of this molecule with cells of the immune system.

Method used

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  • Pharmaceutical Composition Comprising An Antigen
  • Pharmaceutical Composition Comprising An Antigen
  • Pharmaceutical Composition Comprising An Antigen

Examples

Experimental program
Comparison scheme
Effect test

example 1

Induction of Antigen Specific T Cells is Greatly Enhanced by Coinjection of Combination of Poly-L-Arginine and Human Growth Hormone

[0043]

MiceC57BL / 6 (Harlan / Olac)PeptideVYDFFVWL derived from mousetyrosinase related protein-2.Restricted to H-2Kb (Bloom et al.,1997).Dose: 100 μg / mouse.Control peptideSIINFEKL derived from ovalbumin.Restricted to H-2Kb (Carbone andBevan, 1989).Poly-L-arginine 60 (pR60)poly-L-arginine with an averagedegree of polymerization of 60arginine residues; SIGMA chemicalsDose: 100 μg / mouseHuman Growth Hormone (HGH)0.02 IU / injectionSAIZEN, Laboratoires Serono)

[0044]Peptides were synthesized by standard solid phase F-moc synthesis, HPLC purified and analysed by mass spectroscopy for purity.

Experimental Groups (5 Mice Each)

[0045]1) TRP-2 peptide

2) TRP-2 peptide+HGH

3) TRP-2 peptide+pR 60

4) TRP-2 peptide+pR 60+HGH

[0046]On day 0 mice were injected subcutaneously with a total volume of 100 μl containing the above mentioned compounds. Animals were sacrificed 10 days afte...

example 2

Preferred Antigens to be Used for Providing a Vaccine Composition According to the Present Invention

[0048]1. HCV: antigens according to table 1[0049]and the antigens disclosed in Lamonaca et al.,[0050]Hepatology 30(4) (1999), 1088-1098.

Hepatitis C Peptides

[0051]

TABLE 1CD4CD8epitopesSequenceReferencesepitopesSequencesReferencesCoreKFPGGGQIVGGVYL(Hoffmann et al., 1995)CoreDLMGYIPAV(Sarobe et al., 1998)23-44LPRRGPRL132-140(SEQ ID NO:3)(SEQ ID NO:1)E2 / NS1——E2 / NS1FLLLADARV(Wentworth et al., 1996)723-731(SEQ ID NO:17)NS3GYKVLVLNPSVAAT(Diepolder et al., 1997)NS3CINGVCWTV(He et al., 1999;1248-1261(SEQ ID NO:6)1073-1081(SEQ ID NO:4)Rehermann et al., 1996)CoreADLMGYIPLVGAPL(Hoffmann et al., 1995)131-150GGAARA(SEQ ID NO:2)Notes:Core 23-44 contains two CD8 epitopes: core 31-40 (VGGVYLLPRR) (SEQ ID NO:18) and core 35-44 (YLLPRRGPRL) (SEQ ID NO:19) (Battegay et al., 1995; Rehermann et al., 1996)Core 131-150 contains the CD8 epitope core 132-140 (DLMGYIPLV) (SEQ ID NO:20) (Wentworth et al., 1996)

2...

example 3

Co-Injection of Substance P and pArg

[0053]Substance P was tested as a further example for a neuroactive peptide (Marx, Science 205 (1979), 886). Substance P (RPKPQQFFGLM-NH2; SP) was synthesized and purified according to standard procedures. Experiments were conducted as in Example 1 with the exception that spleens instead of lymph nodes were used.

[0054]Splenocytes were prepared from spleens as follows: cells were passed through a 70 μm sieve and washed once with DMEM medium (GIBCO BRL). Red blood cells were lysed with “red blood cells lysis buffer” (Sigma) for 1 minute and washed twice with DMEM medium (GIBCO BRL). Cells were adjusted to 3*106 cells / ml in complete medium (DEMEM+5% FCS). IFN-γ-ELISPOT was carried out as described (Miyahira et al., 1995).

Experimental Groups (2 Mice Each)

[0055]1) TRP-2 peptide

2) TRP-2 peptide+pR 60

3) TRP-2 peptide+pR 60+substance P

Per injection 10 nmoles SP have been administered to mice.

[0056]The results are depicted in FIG. 2. It is demonstrated wit...

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Abstract

The invention relates to immunogenic compositions. In certain embodiments, the invention provides pharmaceutical compositions comprising an antigen, an immunostimulating substance selected from neuroactive compounds, hormones, compounds having a growth hormone activity, and mixtures thereof, and a polycationic polymer.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. application Ser. No. 11 / 082,595 filed 17 Mar. 2005, which is a continuation of U.S. application Ser. No. 10 / 114,823 filed on 1 Apr. 2002, which is a continuation of PCT Application No. PCT / EP00 / 09657 filed 2 Oct. 2000, which claims priority to Austrian Application No. A 1680 / 99 filed 1 Oct. 1999. The entire text of each of the above-referenced disclosures is specifically incorporated by reference herein.BACKGROUND[0002]The invention relates to a pharmaceutical composition especially to be used as a vaccine.[0003]Vaccines are a very successful, yet cost saving medical intervention. Several catastrophic illnesses including small pox and poliomyelitis have been, due to intense vaccination programmes, eliminated from the face of this earth or are on the brink of extinction (Nossal, Nat Med 4, (1998), 475-476). In fact, vaccines can save more lives (and money) than any other medical intervention. Alth...

Claims

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Application Information

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IPC IPC(8): A61K39/00A61K39/39A61P37/04C07K14/18
CPCA61K39/29A61K39/39A61K2039/55511A61K2039/55516A61K2039/55522C12N2770/24234A61K2039/55583C07K14/005C12N2770/24222C12N2710/16234C12N2740/16034A61K2039/55555A61K39/12A61P31/00A61P31/12A61P31/14A61P35/00A61P37/00A61P37/04
Inventor FLEITMANN, JULIA-KRISTINAMATTNER, FRANKBUSCHLE, MICHAELMELLING, JACK
Owner FLEITMANN JULIA KRISTINA
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