Formulations for small intestinal delivery of RSV and norovirus antigens
Inventors
Trager, George • Tucker, Sean • Kim, Leesun • Scallan, Ciaran
Assignees
Publication Number
US-12186407-B2
Publication Date
2025-01-07
Expiration Date
2036-06-08
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Abstract
Provided herein are compositions and methods for generating an immunogenic response in humans. Further provided are methods for designing such compositions, e.g., for vaccines.
Core Innovation
The invention relates to compositions and methods for generating immunogenic responses by delivering immunogenic biological agents, such as vaccines, specifically to the ileum of a subject. It provides immunogenic compositions comprising an immunogenic biological agent that is encompassed by a delivery agent, such as an enteric coating or capsule, that directs release of the agent to the ileum, thus optimizing immune recognition and response.
The problem addressed is the limitations of current vaccine delivery, which often involve injections that require sterile equipment, skilled practitioners, and pose issues of participation and distribution, especially during pandemics. Oral vaccines, if effectively delivered to the target location in the intestine, could overcome these barriers by being easier and safer to administer, and by potentially enhancing immune responses.
The invention encompasses specific enteric coating formulations and delivery systems that ensure release of the vaccine’s active components predominantly in the ileum, protecting them from degradation in the stomach and upper small intestine. The compositions include expression vectors encoding norovirus or RSV antigens, optionally with adjuvants, and are designed to induce both humoral and cellular immune responses. Multiple coating materials and formats, such as poly(methacrylic acid-co-methyl methacrylate) and EUDRAGIT® combinations, ensure flexibility in tablet or capsule formulation for effective ileal delivery.
Claims Coverage
The patent includes one independent claim, which covers a method for eliciting an immune response to a norovirus viral protein 1 (VP1) in a human using a specific composition. There are additional dependent claims detailing refinements and preferred embodiments of this method.
Method for eliciting immune response to norovirus VP1 using specific expression vector
A method for eliciting an immune response to norovirus viral protein 1 (VP1) in a human by administering an immunogenic composition comprising an expression vector. - The expression vector comprises a heterologous nucleic acid encoding a VP1 polypeptide. - The heterologous nucleic acid has at least 90% identity to SEQ ID NO:3 or SEQ ID NO:1. - The method specifically applies to humans.
The primary inventive feature resides in administering an expression vector encoding a norovirus VP1 polypeptide with defined sequence identity, as an immunogenic composition, to elicit an immune response in humans. The dependent claims add specific details about the vector, adjuvants, and enteric coating, but the independent claim establishes the fundamental scope.
Stated Advantages
Targeted delivery of immunogenic biological agents to the ileum results in a much greater immune response than non-targeted or differently targeted delivery.
The invention allows for more effective vaccines and demonstrates increased immunogenicity in humans, as evidenced by higher antibody and T cell responses.
Oral, ileum-targeted vaccination avoids the need for injections, sterile equipment, and skilled administration, facilitating vaccine distribution and participant compliance.
Tableted formulations are rapid, sanitary, and do not require expensive sterile fill and finish processes.
The compositions can provide better durability of immune responses and enhanced induction of mucosal immunity, such as gut SIgA.
Vaccines stable at room temperature and suitable for mail distribution, improving rapid response during pandemics.
Documented Applications
Eliciting immune responses in humans against norovirus by oral administration of ileum-targeted vaccines.
Eliciting immune responses in humans against respiratory syncytial virus (RSV) via similar ileal delivery strategies.
Prophylactic and therapeutic vaccination for viral infections (such as influenza, norovirus, RSV), bacterial infections, parasitic diseases, fungal infections, or cancer.
Improved oral vaccine delivery for pandemic preparedness, enabling distribution by mail to avoid in-person gatherings and human-to-human contact.
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