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Influenza vaccine

a technology of influenza vaccine and vaccine formulation, applied in the field of influenza vaccine formulation and vaccination regime, can solve the problems of high transcription error rate, economic burden, morbidity and even mortality, and amino-acid substitution of surface glycoproteins

Inactive Publication Date: 2007-06-21
SMITHKLINE BEECHAM PHARMA GMBH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Influenza results in an economic burden, morbidity and even mortality, which are significant.
A lack of effective proofreading by the viral RNA polymerase leads to a high rate of transcription errors that can result in amino-acid substitutions in surface glycoproteins.
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, persons at risk in case of an influenza pandemic may be different from the defined risk-groups for complications due to seasonal influenza.
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).
The elderly or those with underlying chronic diseases are most likely to experience such complications, but young infants also may suffer severe disease.
This can result in virus escaping ‘herd immunity’ and establishing pandemics.
If such viruses have the potential to spread from person to person, they may spread worldwide within a few months to a year, resulting in a pandemic.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example i

Immunological Read-out Methods

1.1. Ferrets Methods

[0197] Suitable methods are given below which are routinely used for experiments performed 30 with seasonal strains. The skilled reader will understand that it may need some adaptation or optimization depending on the influenza strain used.

[0198] I.2.1. Hemagglutination Inhibition Test (HI)

[0199] Test Procedure.

[0200] Anti-Hemagglutinin antibody titers to the influenza virus strain are 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). After pre-treatment of sera (cholera, RDE, heat inactivation, . . . ), two-fold dilutions of sera are incubated with 4 hemagglutination units of the influenza strain. Chicken (adaptation: turkey, or horse) red blood cells are then added and the inhibition of agglutination is scored. The titers are ex...

example ii

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

[0268] 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.

II.1. Preparation of emulsion SB62

[0269] II.1.1. Lab-scale Preparation

[0270] 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 tocop...

example iii

Pre-clinical Evaluation of an Adjuvanted Pandemic Split Influenza Vaccines (Comprising H5N1 Strain) in Ferrets

III.1. Rationale and Objectives

[0305] Influenza infection in the ferret model closely mimics human influenza, with regards both to the sensitivity to infection and the clinical response. The ferret is extremely sensitive to infection with both influenza A and B viruses without prior adaptation of viral strains. Therefore, it provides an excellent model system for studies of protection conferred by administered influenza vaccines.

[0306] This study investigated the efficacy of H5N1 Split vaccines adjuvanted with AS03 to protect ferrets against a lethal challenge with a H5N1 homologous strain. The objective of this experiment was to demonstrate the efficacy of an adjuvanted influenza vaccine compared to ferrets immunized with PBS or the adjuvant alone.

III.2. Experimental Design

[0307] III.2.1. Treatment / Group (Table 4)

[0308] Female ferrets (Mustela putorius furo) (6 ferr...

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Abstract

The present invention relates to monovalent influenza vaccine formulations and vaccination regimes for immunising against influenza disease, their use in medicine, in particular their use in augmenting immune responses to various antigens, and to methods of preparation. In particular, the invention relates to monovalent influenza immunogenic compositions comprising an influenza antigen or antigenic preparation thereof from an influenza virus strain being associated with a pandemic outbreak or having the potential to be associated with a pandemic outbreak, in combination with an oil-in-water emulsion adjuvant comprising a metabolisable oil, a sterol or a tocopherol such as alpha tocopherol, and an emulsifying agent.

Description

TECHNICAL FIELD [0001] The present invention relates to influenza vaccine formulations and vaccination regimes for immunising against influenza disease, their use in medicine, in particular their use in augmenting immune responses to various antigens, and to methods of preparation. In particular, the invention relates to monovalent influenza immunogenic compositions comprising an influenza antigen or antigenic preparation thereof from an influenza virus strain that is associated with a pandemic outbreak or has the potential to be associated with a pandemic outbreak, in combination with an oil-in-water emulsion adjuvant. 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 ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K39/395A61K39/12A61K9/12A61K39/00A61K39/145A61K47/02A61P31/16C12N7/02
CPCA61K2039/5252A61K2039/543C12N2760/16234C12N2760/16122A61K2039/54A61K2039/55505C12N7/00C12N2760/16222C07K14/005A61K39/145C12N2760/16151C12N2760/16251A61K39/12A61P31/12A61P31/16A61P37/04
Inventor D'HONDT, ERIKHEHME, NORBERTHANON, EMMANUEL JULESSTEPHENNE, JEAN
Owner SMITHKLINE BEECHAM PHARMA GMBH
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