SARS-CoV-2 vaccines comprising human adenovirus vectors encoding spike and nucleocapsid-ETSD immunogens

Inventors

Soon-Shiong, Patrick • SIELING, Peter • Niazi, Kayvan • Rabizadeh, Shahrooz • Geissert, Lise • Shin, Annie • Rice, Adrian • Gabitzsch, Elizabeth • Safrit, Jeffrey • Sender, Leonard

Assignees

Immunitybio Inc

Abstract

Disclosed herein are methods for inducing immunity against a virus such as a coronavirus in the mucosal tissue of a patient, include administering a vaccine composition to the patient by oral administration (e.g., nasal injection, nasal inhalation, oral inhalation, and/or oral ingestion). Also disclosed are compositions for assaying the presence of anti-viral antibodies induced by the administered vaccine or the presence of viral proteins in a saliva sample include a stabilizing solution and may also include the use of aragonite particle beads. Compositions and methods are presented for prevention and/or treatment of a coronavirus disease wherein the composition comprises a recombinant entity. The recombinant entity is bivalent, comprising a nucleic acid encoding a coronavirus 2 nucleocapsid protein CoV2 nucleocapsid protein fused to an endosomal targeting sequence, and a nucleic acid encoding a CoV2 spike protein sequence optimized for cell surface expression.

Core Innovation

The invention provides a boost vaccine composition for inducing immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) in mucosal tissue of a patient. The patient is primed with a SARS-CoV2 vaccine, and the boost is administered as a defined vaccine composition intended to act at mucosal tissue.

The boost vaccine composition comprises a replication defective human adenovirus serotype 5 (hAd5) vector. The hAd5 comprises an E1 gene region deletion and an E2b gene region deletion, and encodes a SARS-CoV2 S protein together with a nucleic acid portion encoding a chimeric protein comprising a SARS-CoV2 nucleocapsid (N) protein and an endosomal targeting sequence.

The document also describes related concepts for the overall vaccine system, including spike and nucleocapsid immunogens in a bivalent format. It further includes recombinant yeast expressing nucleocapsid/spike, trafficking sequences, and immune modulators, together with mucosal delivery approaches aimed at mucosal and systemic immunity.

Claims Coverage

The independent claim covers a mucosal boost vaccine composition that uses a replication defective hAd5 vector with specified gene deletions and specified immunogen encoding, intended for a patient previously primed with a SARS-CoV2 vaccine. The coverage includes refinement by independent-claim-adjacent constraints on boost timing and administration route, and by additional constraints on construct sequence identifiers in dependent claims.

Overall, the claims coverage centers on a mucosal boost that combines a replication defective hAd5 backbone with defined adenoviral deletions, encodes SARS-CoV2 S protein, and encodes a chimeric nucleocapsid (N) protein linked to an endosomal targeting sequence, with further dependent constraints directed to timing and administration route.

Stated Advantages

Documented Applications