Immunogenic composition against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Inventors
Kuo, Tsun-Yung • Chen, Charles • Wu, Chung-Chin • Lin, Yi-Jiun • Lin, Meei-Yun • Wu, Yu-Chi • CAMPBELL, John Darren • JANSSEN, Robert S. • NOVACK, David • Coffman, Robert • Traquina, Paula
Assignees
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Publication Number
US-12296002-B2
Publication Date
2025-05-13
Expiration Date
Abstract
The present invention relates to an immunogenic composition against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), especially to an immunogenic composition having a recombinant SARS-CoV-2 S protein and adjuvant.
Core Innovation
The immunogenic compositions and methods address SARS-CoV-2 by providing an antigenic recombinant protein and a defined adjuvant system. The antigenic recombinant protein substantially consists of residues 14-1208 of the SARS-CoV-2 S protein, together with proline substitutions at residues 986 and 987 and a “GSAS” substitution at residues 682-685. The recombinant protein further includes a C-terminal T4 fibritin trimerization domain consisting of an amino acid sequence of SEQ ID NO: 2.
The adjuvant is defined as aluminum hydroxide combined with an unmethylated CpG motif consisting of a synthetic oligodeoxynucleotide (ODN) of SEQ ID NO: 8. The compositions are described as immunogenic and are configured to elicit an immune response in a subject in need thereof.
The document frames the approach as solving the need for effective immune responses against SARS-CoV-2, with reported immune outcomes including neutralizing antibodies and a Th1-skewed immune response. Reported data also address neutralization across variants/VoC, with retained but reduced neutralization compared with wild-type SARS-CoV-2.
Claims Coverage
The independent claim coverage includes two independent claims. The first claim is directed to an immunogenic composition with a specific recombinant SARS-CoV-2 S protein fragment, defined substitutions, and a combined aluminum hydroxide plus unmethylated CpG motif adjuvant of SEQ ID NO: 8. The second claim is directed to a method of eliciting an immune response in a subject using the same defined immunogenic composition.
Recombinant SARS-CoV-2 S antigen fragment with specified substitutions and T4 fibritin domain
An antigenic recombinant protein substantially consisting of residues 14-1208 of SARS-CoV-2 S protein with proline substitutions at residues 986 and 987, a “GSAS” substitution at residues 682-685, and a C-terminal T4 fibritin trimerization domain consisting of an amino acid sequence of SEQ ID NO: 2.
Aluminum hydroxide with unmethylated CpG motif ODN adjuvant of SEQ ID NO: 8
An adjuvant consisting of aluminum hydroxide and an unmethylated cytosine-phosphate-guanosine (CpG) motif consisting of a synthetic oligodeoxynucleotide (ODN) of SEQ ID NO: 8.
Administration of effective amount to elicit immune response
Administering to a subject in need thereof an effective amount of an immunogenic composition comprising the antigenic recombinant protein and the adjuvant consisting of aluminum hydroxide and the unmethylated CpG motif consisting of the synthetic ODN of SEQ ID NO: 8, wherein the antigenic recombinant protein substantially consists of the specified residues and substitutions and includes the C-terminal T4 fibritin trimerization domain consisting of an amino acid sequence of SEQ ID NO: 2.
Across the independent claims, the core inventive coverage is the combination of a defined SARS-CoV-2 S protein recombinant antigen with an adjuvant system of aluminum hydroxide and an unmethylated CpG motif synthetic ODN of SEQ ID NO: 8, and the corresponding method of administering an effective amount to elicit an immune response.
Stated Advantages
Elicits neutralizing antibodies against SARS-CoV-2.
Produces a Th1-skewed immune response.
Neutralization is described as reduced but retained across variants/VoC compared with wild-type SARS-CoV-2.
Documented Applications
Phase I human safety and immunogenicity, including seroconversion, neutralizing titers, and IFN-γ/IL-4 ELISpot Th1-skew.
Protective vaccination/effective immune response against SARS-CoV-2 infection in animal models described, including hamster challenge with reduced viral load and lung pathology and described outcomes such as reduced weight loss.
Neutralization assessment against wild-type SARS-CoV-2 and listed variants/VoC including D614G, B.1.351 (Beta), B.1.1.7 (Alpha), and P1 (Gamma) using reported assays.
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