Method and compositions for cutaneous immunisation
Inventors
Ronco, Jorge • Godefroy, Sylvie • Dupont, Bertrand
Assignees
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Publication Number
US-8968743-B2
Publication Date
2015-03-03
Expiration Date
Abstract
The invention concerns the development of a system to deliver vaccines via cutaneous route. The invention more particularly concerns the use of a device comprising a condensation compartment for epicutaneous vaccination. The invention also concerns protocols for epicutaneous vaccination allowing an efficient immune response to be obtained without any skin treatment. The invention can be implemented in any mammal, preferably in human beings, to induce a therapeutic or preventive immune response against any type of antigen.
Core Innovation
The invention relates to an epicutaneous vaccination method in which a dry vaccine formulation comprising an antigen is applied onto intact skin of a mammal having an intact stratum corneum. The dry vaccine formulation is devoid of an adjuvant, and the applying comprises contacting a device to the application site.
The device comprises a condensation compartment configured to accumulate water on the intact skin site so as to hydrate and perturb the stratum corneum without abrasion or perforation. The condensation compartment has a specified geometry and holds a defined quantity of the dry vaccine formulation per unit surface area, enabling antigen entry into the epidermis for immune activation.
The disclosed rationale links hydration and insensible water loss with water-vapor saturation and condensation to support antigen solubilization and skin delivery. The document also describes mechanistic and immunological observations associated with vaccination, including increased skin hydration, epidermal thickening, antigen detection in skin and dendritic cells, and Langerhans cell activation leading to antigen-specific immune responses.
Claims Coverage
The independent claim covers a method for epicutaneous vaccination of a mammal against a pathogen using a dry, adjuvant-free antigen formulation applied to intact skin by a device forming a condensation compartment, with specified device dimensions and antigen dose-per-area parameters.
Adjuvant-free dry antigen on intact stratum corneum
Applying a dry vaccine formulation onto intact skin of the mammal, wherein the skin at the application site has an intact stratum corneum, wherein the dry vaccine formulation comprises an antigen and is devoid of an adjuvant.
Device with a condensation compartment for epicutaneous delivery
Contacting a device to the application site, the device comprising a condensation compartment having a volume ranging between 2 and 100 mm3/cm2 of a surface area of the device and a height between 0.02 and 1 mm, the surface area between 0.2 and 5 cm2, said device containing a quantity of the dry vaccine formulation ranging between 0.1 μg and 500 μg per cm2 of the surface area of the device.
Across the claim scope, the core inventive concept is epicutaneous delivery of an adjuvant-free dry antigen formulation onto intact stratum corneum using a device that forms a condensation compartment with specified geometric parameters and a defined amount of dry formulation per surface area.
Stated Advantages
Rehydrates or perturbs the stratum corneum without abrasion or perforation.
Enables antigen entry into the epidermis for immune activation.
Documented Applications
Epidermal delivery for inducing antigen-specific IgG immune responses, including applications described using selected antigens and measured immune activation markers in skin and dendritic cells.
Vaccination against pathogens exemplified in the document, including viruses and respiratory pathogens, with an example describing partial protection against RSV.
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