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Intradermal influenza vaccine

A technology of influenza vaccine and influenza, which is applied in the field of infectious diseases and drugs, and can solve the problems of non-use

Active Publication Date: 2010-06-23
CRUCELL SWITZERLAND AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, aluminum is not usually used in flu vaccines due to adverse side effects such as pain at the injection site

Method used

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  • Intradermal influenza vaccine
  • Intradermal influenza vaccine
  • Intradermal influenza vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment Embodiment 1

[0048] In another preferred embodiment, the vaccine comprises 1-10 μg of HA antigen from a single strain (or from each of the 3 influenza strains in the case of a trivalent vaccine), eg about 3.0 μg. In a more preferred embodiment, the virion-based influenza vaccine is Berna Biotech AG under the trademark V vaccine commercialized vaccine. Preferably, the invention relates to a method according to the invention, wherein the vaccine does not contain HA from influenza strains A / New Caledonia / 20 / 99, A / Moscow / 10 / 99 and B / Hong Kong / 330 / 2001 Trivalent combination of antigens. As indicated herein, administration is preferably performed using a delivery device suitable for intradermal delivery of the vaccine. A device suitable for intradermal delivery may be a single hypodermic needle. It was found that some devices were prepared so that the needle could not pass through the cortex, which would result in sub-optimal intradermal delivery. In other words, some devices contain relati...

Embodiment 2

[0051] These studies showed that when virion-based influenza vaccines were administered intradermally to humans at a concentration of 3 μg of each strain (two A strains and one B strain), seroconversion and GMT criteria were positive for all three strains. is met, and the seroprotection rate of at least two A strains is met. This is very unexpected and in stark contrast to what was disclosed in WO2004 / 016281, where it was shown that this type of vaccination did not meet the standards set by the authorities for any of the three strains used therein. Example 2. Dose Escalation (and Intramuscular vs. Intradermal) Studies with Virosome-Based Influenza Vaccines in Human Individuals

[0052] A second clinical study involving human subjects was conducted to evaluate the humoral immune response to an intradermally administered seasonal virion-adjuvanted influenza vaccine. This included a single-center, randomized dose-escalation study in which a volume of 0.1 mL of trivalent V Infl...

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Abstract

The invention relates to virosome-based influenza vaccines for the manufacture of medicaments that are administered intradermally in humans. The invention provides (trivalent) compositions comprising low doses of hemagglutinin (HA) antigen in a virosomal preparation that fulfill the immune response standards with respect to seroconversion rates, GMT-fold increase and protection rates, for use in vaccination set-ups.

Description

field of invention [0001] The invention relates to the field of medicine, especially the field of infectious diseases. More specifically, the invention relates to the use of vaccines comprising virosomes in the manufacture of medicaments for the prophylactic treatment of influenza infections. Background of the invention [0002] Influenza viruses (members of the Orthomyxoviridae family) are the causative agents of annual epidemics of acute respiratory disease. Influenza epidemics and pandemics continue to claim human life and affect the global economy. In the U.S. alone, 50 million Americans get the flu each year. It is estimated that the number of deaths per year worldwide (1972-1992) is 60,000 (CDC statistics). In addition to seasonal epidemics, there have been three major influenza pandemics in the last century. A classic example of a severe influenza pandemic is the "Spanish Flu" of 1918-1919, which killed an estimated 40-50 million people worldwide. Other pandemics...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/145A61K9/127
CPCA61K9/0019A61K2039/54C12N2760/16123C12N7/00C12N2760/16134A61K39/295A61K2039/5258C12N2760/16234A61K39/145A61K39/12A61K2039/70A61P31/16A61K39/135A61K9/127
Inventor C·赫尔佐克H·拉扎尔
Owner CRUCELL SWITZERLAND AG
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