Adjuvanted mucosal subunit vaccines for preventing sars-cov-2 transmission and infection
AssigneeThe United States of America, as represented by the Secretary, Depart. of Health and Human Services
InventorsJay A. Berzofsky, Yongjun Sui
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Abstract
Immunogenic compositions that include SARS-CoV-2 spike (S) protein, S1 protein, or S2 protein, and an adjuvant, such as alum, or a combination of CpG oligodeoxynucleotide, Poly I:C, and IL-15, and nanoparticle compositions that include SARS-CoV-2 S protein, S1 protein, or S2 protein, and CpG oligonucleotide, poly(I:C), and IL-15, are provided. Also provided are methods of using such compositions, for example a prime intramuscular administration followed by one or more intranasal boosters that include the disclosed nanoparticles, to generate an immune response to SARS-CoV-2 in a subject, for example respiratory mucosal immunity, for example to prevent SARS-CoV-2 infection or transmission to other subjects.
Claims24
An immunogenic composition, comprising
- (a) a SARS-CoV-2 protein comprising
- a SARS-COV-2 Spike 1 (S1) protein comprising at least 80%, least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99%, or 100% sequence identity to SEQ ID NO:
- 2, 3, 4, 5, 6, 12 or 15;
- a SARS-COV-2 S2 protein comprising at least 80%, least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99%, or 100% sequence identity to SEQ ID NO:
- 9, 13 or 16;
- or
- a SARS-COV-2 Spike (S) protein comprising at least 80%, least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99%, or 100% sequence identity to SEQ ID NO:
- 1, 11 or 14, or to amino acids 16-1208 of SEQ ID NO:
- 1, amino acids 16-1205 of SEQ ID NO:
- 11, or amino acids 16-1206 of SEQ ID NO:
- 14;
- and
- (b) CpG oligodeoxynucleotide, Poly I:C and IL-15;
- or
- CpG oligodeoxynucleotide, Poly I:C, IL-15, or combinations thereof.
(canceled)
A nanoparticle, comprising
- (a) a SARS-CoV-2 Spike (S) protein comprising
- a SARS-COV-2 S1 protein comprising at least 80%, least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99%, or 100% sequence identity to SEQ ID NO:
- 2, 3, 4, 5, 6, 12 or 15;
- a SARS-COV-2 S2 protein comprising at least 80%, least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99%, or 100% sequence identity to SEQ ID NO:
- 9, 13 or 16;
- or
- a SARS-COV-2 S protein comprising at least 80%, least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99%, or 100% sequence identity to SEQ ID NO:
- 1, 11 or 14, or to amino acids 16-1208 of SEQ ID NO:
- 1, amino acids 16-1205 of SEQ ID NO:
- 11, or amino acids 16-1206 of SEQ ID NO:
- 14;
- and
- (b) CpG oligodeoxynucleotide, Poly I:C and IL-15;
- or
- CpG oligodeoxynucleotide, Poly I:C, IL-15, or combinations thereof.
-7. (canceled)
(canceled)
-21. (canceled)
A method of eliciting an immune response against SARS-CoV-2 in a subject, comprising:
- administering to the subject an effective amount of a primary dose an immunogenic composition comprising the SARS-CoV-2 S1 protein of SEQ ID NO:
- 2, and alum;
- and
- subsequently administering to the subject an effective amount of one or more booster doses of nanoparticles comprising the SARS-CoV-2 S1 protein of SEQ ID NO:
- 2, CpG oligodeoxynucleotide, Poly I:C, and IL-15.
-26. (canceled)
Dependencies are inferred from the claim text.