This invention is a patch of dissolvable microneedles loaded with a nanoparticle vaccine (a self-assembling carrier protein, a pathogen antigen and an adjuvant) that delivers the vaccine into the skin. It elicits strong antibody responses in mice and retains immunogenicity after room-temperature storage, which could simplify vaccine distribution and administration.
Description
Unmet Need - Injected vaccines typically rely on cold-chain storage and needle-and-syringe delivery, and this patch delivers a nanoparticle vaccine into the epidermis and dermis without systemic exposure, with extended room-temperature stability.
The platform is a patch with a base and an array of microneedles. The needles are made of water-soluble, dissolvable materials (for example, carboxymethyl cellulose combined with trehalose), and the vaccine is loaded in them, optionally concentrated at the needle tip. The vaccine has three parts: a nanoparticle-forming protein (such as ferritin, which assembles into a nanoparticle that presents antigens in an orderly array), a pathogen-derived antigen, and an adjuvant (an immune-boosting ingredient). Antigen and carrier can be joined through a linker into a single fusion protein. Vaccine and adjuvant can be loaded in the same or different needles, and optionally on metal-organic frameworks, which are porous carrier structures.
The patch is applied to the skin, where the needles pass through the outer skin barrier and dissolve to release the vaccine into the immune-rich layers beneath. The platform accepts antigens from many viruses, bacteria, parasites and tumor targets, with a range of adjuvants. It also includes a molding-based manufacturing method. A flexible mold with undercut features forms needles with a stem, head and filleted base, and layers with different dissolution rates can be built in.
Applications
- Skin-patch vaccines against COVID-19 and other coronavirus diseases
- Vaccines for emerging and high-consequence viral threats, such as arenaviruses (e.g., Lassa), Ebola and influenza
- HIV-1 vaccine delivery
- Vaccines for bacterial and parasitic diseases using the same patch format
- Needle-free or self-administered vaccination programs and settings where cold-chain storage is limited
Advantages
- Delivers vaccine to the epidermis and dermis without systemic exposure
- Dissolvable microneedles remove the need for a conventional injection
- Antibody responses in mice, including neutralizing antibodies, were higher than with intramuscular injection of the same vaccine
- Extended stability at room temperature (immunogenicity retained for at least 45 days without refrigeration in mice)
- Flexible platform that accommodates different antigens, nanoparticle carriers, adjuvants and loading formats
Invention Readiness
The technology has been demonstrated in mouse models. Dissolvable patches loaded with a spike-ferritin nanoparticle vaccine and several adjuvants were fabricated and characterized, including skin penetration and delivery imaging. Patch immunization produced binding and neutralizing antibody responses against SARS-CoV-2 and variants that were superior or comparable to intramuscular injection. Antibody and T-cell responses were also measured in young and aged mice, serum IL-6 was assessed after immunization, and patches stored at room temperature for 45 days retained immunogenicity.
IP Status
https://patents.google.com/patent/WO2025231364A1
