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Use Of An Influenza Virus, An Oil-In-Water Emulsion Adjuvant, To Induce Cd4 T-Cell And/Or Improved B-Memory Cell Response

a technology of oil-in-water emulsion and influenza virus, which is applied in the field of influenza vaccine formulations and vaccination regimes, can solve the problems of increased hospitalization or mortality, significant morbidity and even mortality, and increased incidence of pneumonia and lower respiratory disease, and achieves the effect of improving the cd4 respons

Inactive Publication Date: 2008-07-31
GLAXOSMITHKLINE BIOLOGICALS SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides an immunogenic composition that can induce a better CD4 T-cell immune response and a better B-memory cell response against influenza virus or antigenic preparations thereof in humans. This is achieved by using an oil-in-water emulsion adjuvant containing a metabolisable oil, a sterol (such as alpha-tocopherol), and an emulsifying agent. The oil-in-water emulsion adjuvant has oil droplets of which at least 70% by intensity have diameters of less than 1 μm. The immunogenic composition can be used for vaccination of immuncompromised individuals or populations, such as high risk adults or elderly, against influenza virus or a variant of the influenza virus strain. The oil-in-water emulsion adjuvant helps to improve the immunogenicity of the vaccine and to induce immunological memory against the influenza virus.

Problems solved by technology

Influenza results in an economic burden, morbidity and even mortality, which are significant.
Typical influenza epidemics cause increases in incidence of pneumonia and lower respiratory disease as witnessed by increased rates of hospitalization or mortality.
Individuals with underlying chronic diseases are also most likely to experience such complications.
Young infants also may suffer severe disease.
However, there is little evidence that current influenza vaccines work in small children under two years of age.
However, in a later publication, the same vaccine has not demonstrated its improved profile compared to a non-adjuvanted split vaccine (Puig-Barbera et al., 2004, Vaccine 23, 283-289).

Method used

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  • Use Of An Influenza Virus, An Oil-In-Water Emulsion Adjuvant, To Induce Cd4 T-Cell And/Or Improved B-Memory Cell Response
  • Use Of An Influenza Virus, An Oil-In-Water Emulsion Adjuvant, To Induce Cd4 T-Cell And/Or Improved B-Memory Cell Response
  • Use Of An Influenza Virus, An Oil-In-Water Emulsion Adjuvant, To Induce Cd4 T-Cell And/Or Improved B-Memory Cell Response

Examples

Experimental program
Comparison scheme
Effect test

example i

Immunological Read-Out Methods

[0242]I.1. Mice Methods

[0243]I.1.1. Hemagglutination Inhibition Test

[0244]Test Procedure

[0245]Anti-Hemagglutinin antibody titers to the three influenza virus strains were determined using the hemagglutination inhibition test (HI). The principle of the HI test is based on the ability of specific anti-influenza antibodies to inhibit hemagglutination of chicken red blood cells (RBC) by influenza virus hemagglutinin (HA). Heat inactivated sera were previously treated by Kaolin and chicken RBC to remove non-specific inhibitors. After pretreatment, two-fold dilutions of sera were incubated with 4 hemagglutination units of each influenza strain. Chicken red blood cells were then added and the inhibition of agglutination was scored. The titers were expressed as the reciprocal of the highest dilution of serum that completely inhibited hemagglutination. As the first dilution of sera was 1:20, an undetectable level was scored as a titer equal to 10.

[0246]Statistic...

example ii

Preparation and Characterization of the Oil in Water Emulsion and Adjuvant Formulations

[0332]Unless otherwise stated, the oil / water emulsion used in the subsequent examples is composed an organic phase made of 2 oils (alpha-tocopherol and squalene), and an aqueous phase of PBS containing Tween 80 as emulsifying agent. Unless otherwise stated, the oil in water emulsion adjuvant formulations used in the subsequent examples were made comprising the following oil in water emulsion component (final concentrations given): 2.5% squalene (v / v), 2.5% alpha-tocopherol (v / v), 0.9% polyoxyethylene sorbitan monooleate (v / v) (Tween 80), see WO 95 / 17210. This emulsion, termed AS03 in the subsequent examples, was prepared as followed as a two-fold concentrate.

[0333]II.1. Preparation of Emulsion SB62

[0334]II.1.1. Lab-Scale Preparation

[0335]Tween 80 is dissolved in phosphate buffered saline (PBS) to give a 2% solution in the PBS. To provide 100 ml two-fold concentrate emulsion 5 g of DL alpha tocophe...

example iii

Clinical Trial in an Elderly Population Aged Over 65 Years with a Vaccine Containing a Split Influenza Antigen Preparation and AS03 Adjuvant (Explo-Flu-001)

[0405]A phase I, open, randomised study was conducted in an elderly population aged over 65 years in 2003 in order to evaluate the reactogenicity and the immunogenicity of GlaxoSmithKline Biologicals influenza candidate vaccine containing the adjuvant AS03. The humoral immune response (i.e. anti-hemagglutinin, neutralising and anti-neuraminidase antibody titres) and cell mediated immune response (CD4 and / or CD8 T cell responses) was measured 21 days after intramuscular administration of one dose of an AS03 adjuvanted vaccine or a WV vaccine. Fluarix™ was used as reference.

[0406]III.1. Study Design

[0407]Three groups of subjects in parallel received the following vaccine intramuscularly:[0408]one group of 50 subjects receiving one dose of the reconstituted and adjuvanted SV influenza vaccine (FluAS03)[0409]one group of 50 subjects ...

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Abstract

The present invention relates to influenza vaccine formulations and vaccination regimes for immunising against influenza disease. In particular the invention relates to vaccine formulations comprising an oil-in-water emulsion adjuvant and optionally 3D-MPL, their use in medicine, in particular their use in augmenting immune responses to influenza antigens, and to methods of preparation, wherein the oil in water emulsion comprises a sterol, a metabolisable oil and an emulsifying agent.

Description

TECHNICAL FIELD[0001]The present invention relates to influenza vaccine formulations and vaccination regimes for immunising against influenza disease. In particular the invention relates to vaccine formulations comprising an oil-in-water emulsion adjuvant and optionally 3D-MPL, their use in medicine, in particular their use in augmenting immune responses to influenza antigens, and to methods of preparation, wherein the oil in water emulsion comprises a sterol, a metabolisable oil and an emulsifying agent.TECHNICAL BACKGROUND[0002]Influenza viruses are one of the most ubiquitous viruses present in the world, affecting both humans and livestock. Influenza results in an economic burden, morbidity and even mortality, which are significant.[0003]The influenza virus is an RNA enveloped virus with a particle size of about 125 nm in diameter. It consists basically of an internal nucleocapsid or core of ribonucleic acid (RNA) associated with nucleoprotein, surrounded by a viral envelope with...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K39/145
CPCA61K39/145A61K39/39A61K2039/55511C12N2760/16134C12N2760/16234A61K39/12A61K2039/57A61K2039/55566C12N7/00C12N2760/16034A61K2039/55A61K2039/55572A61K2039/70A61P31/00A61P31/12A61P31/14A61P31/16A61P37/04A61P43/00A61K39/155C07K14/11A61K2039/545
Inventor HANON, EMMANUEL JULESSTEPHENNE, JEAN
Owner GLAXOSMITHKLINE BIOLOGICALS SA
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