IP Library › Granted Patent US 12,290,558
Granted Patent B2
US 12,290,558 · App. 18/488,629 · Granted May 6, 2025

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

Inventors: Patrick Soon-Shiong (Culver City, CA); Peter Sieling (Culver City, CA); Kayvan Niazi (Culver City, CA); Shahrooz Rabizadeh (Agoura Hills, CA); Lise Geissert (Culver City, CA); Annie Shin (Culver City, CA); Adrian Rice (Culver City, CA); Elizabeth Gabitzsch (Culver City, CA); Jeffrey Safrit (Culver City, CA); Leonard Sender (Culver City, CA)
Assignee: ImmunityBio, Inc.
A61K39/215C12N15/861A61K39/39A61K2039/545A61K2039/55505A61P31/14C07K2319/06C12N15/86C12N2710/10343C12N2770/20022C12N2770/20034
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Quick Facts
Patent No.
US 12,290,558
App. No.
18/488,629
Granted
May 6, 2025
Kind
B2
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.

Claims (13)

1. A boost vaccine composition for use in inducing immunity against a severe acute respiratory syndrome (SARS) coronavirus 2 (SARS-CoV2) in mucosal tissue of a patient,

wherein the patient has been primed with a SARS-CoV2 vaccine, and

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

2. The vaccine composition of claim 1 , further comprising administering by injection to the patient a second boost vaccine comprising an anti-SARS-CoV2 vaccine, wherein the anti-SARS-CoV2 vaccine injection comprises a nucleotide encoding SARS-CoV2 spike(S) and/or nucleocapsid (N) protein, and wherein injection includes intramuscular (IM) injection, (IV) intravenous injection, and/or subcutaneous injection.

3. The vaccine composition of claim 1 , wherein the boost immunization is administered at least 7 days after the initial prime vaccination, for example at least 8 days, at least 9 days, at least 10 days, at least 11 days, at least 12 days, at least 13 days, at least 14 days, at least 15 days, at least 16 days, at least 17 days, at least 18 days, at least 19 days, at least 20 days, at least 21 days, at least 28 days, at least 35 days, or at least 42 days after the prime vaccination.

4. The vaccine composition of claim 1 , wherein the prime vaccination further comprises an RNA encoding a SARS-CoV2 N protein.

5. The vaccine composition of claim 1 , wherein the adenoviral vaccine composition comprises SEQ ID NO:3.

6. The vaccine composition of claim 1 , wherein the adenoviral vaccine composition comprises SEQ ID NO:7.

7. The vaccine composition of claim 1 , wherein the boost vaccine composition is formulated for administration to nasal mucosa.

8. The vaccine composition of claim 1 , wherein the boost vaccine composition is formulated for oral administration to the patient.

9. The vaccine composition of claim 1 , wherein the boost vaccine composition is formulated for subcutaneous administration to the patient.

10. The vaccine composition of claim 1 , wherein the boost vaccine composition is formulated for sublingual administration to the patient.

11. The vaccine composition of claim 1 , wherein the boost vaccine composition is formulated for intramuscular administration to the patient.

Continuity (27)
Continuation 17198164 · Mar 10, 2021
Continuation In Part 17082994 · Oct 28, 2020
Continuation In Part 16883263 · May 26, 2020
Continuation In Part 16880804 · May 21, 2020
Provisional Application 63135380 · Jan 8, 2021
Provisional Application 63121102 · Dec 3, 2020
Provisional Application 63118697 · Nov 26, 2020
Provisional Application 63117922 · Nov 24, 2020
Provisional Application 63117460 · Nov 24, 2020
Provisional Application 63117847 · Nov 24, 2020
Provisional Application 63115127 · Nov 18, 2020
Provisional Application 63082145 · Sep 23, 2020
Provisional Application 63080887 · Sep 21, 2020
Provisional Application 63069598 · Aug 24, 2020
Provisional Application 63067033 · Aug 18, 2020
Provisional Application 63064157 · Aug 11, 2020
Provisional Application 63059975 · Aug 1, 2020
Provisional Application 63053691 · Jul 19, 2020
Provisional Application 63036445 · Jun 9, 2020
Provisional Application 63022146 · May 8, 2020
Provisional Application 63016048 · Apr 27, 2020
Provisional Application 63016241 · Apr 27, 2020
Provisional Application 63009960 · Apr 14, 2020
Provisional Application 63010010 · Apr 14, 2020
Provisional Application 62991504 · Mar 18, 2020
Provisional Application 62988328 · Mar 11, 2020
Related Publication 20240075129A1 · Mar 7, 2024
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