Immunogenic compositions and methods for immunization against variants of severe acute respiratory syndrome coronavirus 2 (sars-cov-2)

Patent metadata

Field	Value
Publication number	US-2024197862-A1
Application number	US-202418592811-A
Country	US
Kind code	A1
Filing date	Mar 1, 2024
Priority date	Sep 2, 2021
Publication date	Jun 20, 2024
Grant date	—

Abstract

The present invention relates to immunogenic compositions and methods for immunization against variants of severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), especially to an immunogenic composition having a recombinant SARS-CoV-2 S protein derived from Beta (B.1.351) variant and methods using an immunogenic composition derived from SARS-COV-2 Beta (B.1.351) variant.

First claim

What is claimed is:

1 . An immunogenic composition against a severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), comprising an antigenic recombinant protein and an adjuvant selected from the group consisting of an aluminum-containing adjuvant, an unmethylated cytosine-phosphate-guanosine (CpG) motif, and a combination thereof, wherein the antigenic recombinant protein substantially consists of residues 14-1205 of spike protein of SARS-COV-2 Beta variant with proline substitutions at residues 983 and 984 and a “GSAS” substitution at residues 679-682 and a C-terminal T4 fibritin trimerization domain.

2 . The immunogenic composition of claim 1 , wherein the antigenic recombinant protein comprises an amino acid sequence of SEQ ID NO: 14 or 15, or the amino acid sequence at least 95%, 96%, 97%, 98%, or 99% identical to SEQ ID NO: 14 or 15.

3 . The immunogenic composition of claim 1 , wherein the aluminum-containing adjuvant comprises aluminum hydroxide, aluminum oxyhydroxide, aluminum hydroxide gel, aluminum phosphate, aluminum phosphate gel, aluminum hydroxyphosphate, aluminum hydroxyphosphate sulfate, amorphous aluminum hydroxyphosphate sulfate, potassium aluminum sulfate, aluminum monostearate or a combination thereof.

4 . The immunogenic composition of claim 1 , wherein a 0.5 ml dose of the immunogenic composition comprises from about 250 to about 1500 μg Al 3+ , or about 375 μg Al 3+ or about 750 μg Al 3+ .

5 . The immunogenic composition of claim 1 , wherein the unmethylated CpG motif comprises a synthetic oligodeoxynucleotide (ODN) of SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, or a combination thereof.

6 . The immunogenic composition of claim 1 , wherein a 0.5 ml dose of the immunogenic composition comprises from about 750 to about 3000 μg of the unmethylated CpG motif, or about 750 μg, 1500 μg, or 3000 μg of the unmethylated CpG motif.

7 . The immunogenic composition of claim 1 , wherein the immunogenic composition can be stored at 40° C. to 42° C. for 3 to 7 days.

8 . A method for eliciting an immune response against a severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) in a subject in need thereof, comprising administering to the subject at least one dose of an immunogenic composition of claim 1 .

9 . The method of claim 8 , wherein the subject is administered a first dose and a second dose of the immunogenic composition of claim 1 with a suitable interval between the first dose and the second dose.

10 . The method of claim 8 , wherein the subject is administered a first dose, a second dose, and a third dose of the immunogenic composition of claim 1 with a first suitable interval between the first dose and the second dose, and with a second suitable interval between the second dose and the third dose.

11 . The method of claim 8 , wherein the subject is administered a first dose of an immunogenic composition derived from SARS-COV-2 wild type (WT) strain, and a second dose of the immunogenic composition of claim 1 with a suitable interval between the first dose and the second dose, and wherein the immunogenic composition derived from SARS-COV-2 WT strain comprises a polynucleotide sequence encoding a polypeptide sequence at least 90%, 95%, 96%, 97%, 98%, 99%, or 100% identical to SEQ ID NO: 5 or 6 or a polypeptide sequence at least 90%, 95%, 96%, 97%, 98%, 99%, or 100% identical to SEQ ID NO: 5 or 6.

12 . The method of claim 11 , wherein the immunogenic composition derived from SARS-COV-2 WT strain comprises a polypeptide sequence at least 90%, 95%, 96%, 97%, 98%, 99%, or 100% identical to SEQ ID NO: 5 or 6, and an adjuvant selected from the group consisting of an aluminum-containing adjuvant, an unmethylated cytosine-phosphate-guanosine (CpG) motif, and a combination thereof.

13 . The method of claim 8 , wherein the subject is administered a first dose and a second dose of an immunogenic composition derived from SARS-COV-2 WT strain, and a third dose of the immunogenic composition of claim 1 with a first suitable interval between the first dose and the second dose, and with a second suitable interval between the second dose and the third dose, and wherein the immunogenic composition derived from SARS-COV-2 WT strain comprises a polynucleotide sequence encoding a polypeptide sequence at least 90%, 95%, 96%, 97%, 98%, 99%, or 100% identical to SEQ ID NO: 5 or 6 or a polypeptide sequence at least 90%, 95%, 96%, 97%, 98%, 99%, or 100% identical to SEQ ID NO: 5 or 6.

14 . The method of claim 13 , wherein the immunogenic composition derived from SARS-COV-2 WT strain comprises a polypeptide sequence at least 90%, 95%, 96%, 97%, 98%, 99%, or 100% identical to SEQ ID NO: 5 or 6, and an adjuvant selected from the group consisting of an aluminum-containing adjuvant, an unmethylated cytosine-phosphate-guanosine (CpG) motif, and a combination thereof.

15 . The method of claim 8 , wherein the subject is administered a first dose, a second dose, and a third dose of an immunogenic composition derived from SARS-COV-2 WT strain, and a fourth dose of the immunogenic composition of claim 1 with a first suitable interval between the first dose and the second dose, a second suitable interval between the second dose and the third dose, and a third suitable interval between the third dose and the fourth dose, and wherein the immunogenic composition derived from SARS-COV-2 WT strain comprises a polynucleotide sequence encoding a polypeptide sequence at least 90%, 95%, 96%, 97%, 98%, 99%, or 100% identical to SEQ ID NO: 5 or 6 or a polypeptide sequence at least 90%, 95%, 96%, 97%, 98%, 99%, or 100% identical to SEQ ID NO: 5 or 6.

16 . The method of claim 15 , wherein the immunogenic composition derived from SARS-COV-2 WT strain comprises a polypeptide sequence at least 90%, 95%, 96%, 97%, 98%, 99%, or 100% identical to SEQ ID NO: 5 or 6, and an adjuvant selected from the group consisting of an aluminum-containing adjuvant, an unmethylated cytosine-phosphate-guanosine (CpG) motif, and a combination thereof.

17 . The method of claim 8 , wherein the subject is administered a first dose of an immunogenic composition derived from SARS-COV-2 WT strain, and a second dose and a third dose of the immunogenic composition of claim 1 with a first suitable interval between the first dose and the second dose, and with a second suitable interval between the second dose and the third dose, and wherein the immunogenic composition derived from SARS-COV-2 WT strain comprises a polynucleotide sequence encoding a polypeptide sequence at least 90%, 95%, 96%, 97%, 98%, 99%, or 100% identical to SEQ ID NO: 5 or 6 or a polypeptide sequence at least 90%, 95%, 96%, 97%, 98%, 99%, or 100% identical to SEQ ID NO: 5 or 6.

18 . The method of claim 17 , wherein the immunogenic composition derived from SARS-COV-2 WT strain comprises a polypeptide sequence at least 90%, 95%, 96%, 97%, 98%, 99%, or 100% identical to SEQ ID NO: 5 or 6, and an adjuvant selected from the group consisting of an aluminum-containing adjuvant, an unmethylated cytosine-phosphate-guanosine (CpG) motif, and a combination thereof.

19 . The method of claim 8 , wherein the severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) is a WT strain or a variant.

20 . The method of claim 8 , wherein the immunogenic composition is administered by intramuscular injection.

Assignees

• Medigen Vaccine Biologics Corp
• Dynavax Tech Corp

Inventors

• Chen Charles
• Kuo Tsun-Yung
• Wu Chung-Chin
• Tang Wei-Hsuan
• Lien Chia-En
• Lin Yi-Jiun
• Lin Meei-Yun

Classifications

• C12N2770/20071

  Demonstrated in vivo effect · CPC title

• C12N2770/20034

  Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein · CPC title

• C12N2770/20022

  New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes · CPC title

• C12N7/00

  Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00) · CPC title

• A61K2039/55561

  CpG containing adjuvants; Oligonucleotide containing adjuvants · CPC title