Optimized epicutaneous vaccination
Inventors
PHAM, HONG THAI • Donne, Nathalie • HERVE, PIERRE-LOUIS • Mondoulet, Lucie
Assignees
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Publication Number
US-11938178-B2
Publication Date
2024-03-26
Expiration Date
Abstract
The present invention relates to improved epicutaneous administration methods for vaccination of a subject. In particular, the present invention discloses the use of an antigen for epicutaneous immunization, wherein the antigen is administered by epicutaneous application with a skin patch device in combination with an epidermal skin treatment.
Core Innovation
A method for providing a boosting vaccination against a bacterial pathogen in a primed subject performs skin micro-perforation in a skin area with a laser microporator to form an array of micropores. The skin micro-perforation does not alter the basal layer of the epidermis, and the array of micropores extends from the surface of the skin through one or several epidermis layers but without extending to the dermis.
After forming the array of micropores, the method epicutaneously administers an antigen from the bacterial pathogen on the skin area by means of a skin patch. The skin patch is occlusive and comprises a backing suitable to create a hermetically closed condensation chamber on skin, and the antigen is deposited on the skin facing side of the backing in dry form, optionally in combination with one or several pharmaceutically acceptable excipients.
For boosting vaccination against Bordetella pertussis, the method further combines laser microporator skin micro-perforation with epicutaneous administration of a detoxified pertussis toxin (PT) using the occlusive, hermetically closed condensation chamber patch. The micropore array is constrained to extend through one or several epidermis layers without extending to the dermis and without altering the basal layer of the epidermis, and the patch is applied on the micro-perforated skin area during at least 12 hours.
Claims Coverage
Two independent claims are present. Both define boosting vaccination in a primed subject using laser microporator-based epidermis-confined skin micro-perforation followed by epicutaneous delivery of an antigen from a skin patch that forms a hermetically closed condensation chamber with dry antigen deposition; the Bordetella pertussis claim further specifies detoxified PT and patch application for at least 12 hours.
Laser microporator skin micro-perforation confined to epidermis layers
Performing skin micro-perforation in a skin area with a laser microporator so as to form an array of micropores, the skin micro-perforation not altering the basal layer of the epidermis, and the array of micropores extending from the surface of the skin through one or several epidermis layers but without extending to the dermis.
Occlusive condensation-chamber skin patch with dry antigen deposition
Epicutaneously administering an antigen from the bacterial pathogen on said skin area by means of a skin patch, wherein the skin patch is occlusive and comprises a backing suitable to create a hermetically closed condensation chamber on skin, and wherein the antigen is deposited on the skin facing side of said backing, in dry form, optionally in combination with one or several pharmaceutically acceptable excipients.
Micro-perforated epidermis boosting with detoxified pertussis toxin
A method for providing a boosting vaccination against Bordetella pertussis in a primed subject comprising performing skin micro-perforation with a laser microporator and epicutaneously administering a detoxified pertussis toxin (PT) on said skin area by means of a skin patch applied on the micro-perforated skin area during at least 12 hours, wherein the micropores extend through one or several epidermis layers but without extending to the dermis and do not alter the basal layer of the epidermis, and wherein the patch is occlusive with a backing suitable to create a hermetically closed condensation chamber and the detoxified PT is deposited on the skin facing side of said backing in dry form.
Across both independent claims, the inventive concept is the combination of laser microporator skin micro-perforation confined to epidermis layers without altering the basal layer, followed by epicutaneous delivery using an occlusive patch that forms a hermetically closed condensation chamber and deposits the antigen in dry form; the Bordetella pertussis embodiment specifically uses detoxified PT and applies the patch for at least 12 hours.
Stated Advantages
Enhanced antigen delivery and immune response as described in the document.
Increased antigen uptake by skin dendritic cells/LC and cDC1 and cDC2.
Increased migration to draining lymph nodes.
Stronger antigen-specific immunity, including OVA-specific immunity described in the document.
Improved humoral responses for pertussis with micro-perforation-assisted Viaskin-delivered genetically detoxified PT, enabling antigen dose reduction as reported in the document.
Improved safety and substantially increased seroconversion and PT-specific IgG titers with micro-perforation-assisted patches versus Viaskin alone as reported in the phase I human study.
Documented Applications
Boosting vaccination against a bacterial pathogen in a primed subject.
Boosting vaccination against Bordetella pertussis in a primed subject.
Use of the disclosed approach with Viaskin patches delivering genetically detoxified pertussis toxin (PT), including a phase I human booster study and preclinical results reporting dendritic cell uptake, migration, and immune responses.
Preclinical demonstration of the approach using OVA to report increased antigen uptake by skin dendritic cells/LC and cDC1 and cDC2, migration to draining lymph nodes, and stronger OVA-specific immunity.
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