CpG-adjuvanted SARS-CoV-2 virus vaccine
Inventors
Meinke, Andreas • Möhlen, Michael • Reinisch, Christoph • Schlegl, Robert • Taucher, Christian • Campbell, John • NOVACK, David • JANSSEN, Robert S. • HEINDL-WRUSS, Jürgen
Assignees
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Publication Number
US-11684669-B2
Publication Date
2023-06-27
Expiration Date
Abstract
Described herein are CpG-adjuvanted SARS-CoV-2 vaccines and compositions and methods of producing and administering said vaccines to subjects in need thereof.
Core Innovation
The invention relates to a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunogenic composition including inactivated SARS-CoV-2 whole virus particles comprising an S protein having at least 96% amino acid sequence identity to SEQ ID NO: 3, a CpG-containing oligodeoxynucleotide (CpG-ODN) consisting of the sequence of SEQ ID NO: 4, and an alum adjuvant. The composition is configured to induce neutralizing antibodies against SARS-CoV-2 after intramuscular immunization.
The disclosed vaccine composition addresses immune safety concerns including antibody-dependent enhancement of SARS-CoV-2-associated disease and Th2-driven immunopathology, while preserving native spike epitopes via mild inactivation. The content further states that inactivation targets viral RNA and that the immunogenic composition does not induce antibody-dependent enhancement of SARS-CoV-2-associated disease.
The inactivated whole-virus component is described with mild inactivation conditions and antigen quantification and testing. The document also reports preclinical immunogenicity and neutralization testing, ADE and immunopathology testing, and Phase 1/2 clinical safety and immunogenicity readouts including neutralizing antibodies, IgG ELISA, and IFN-γ T-cell responses.
Claims Coverage
The independent claims center on a specific immunogenic composition and a corresponding production method. Across these claims, the inventive features are an inactivated SARS-CoV-2 whole virus particle with a defined S protein sequence identity, a CpG-ODN defined by SEQ ID NO: 4, and an alum adjuvant, with the stated performance of inducing neutralizing antibodies without inducing antibody-dependent enhancement.
Inactivated SARS-CoV-2 whole virus with defined S sequence identity
An inactivated SARS-CoV-2 whole virus particle comprising an S protein having at least 96% amino acid sequence identity to SEQ ID NO: 3.
CpG-ODN with SEQ ID NO: 4 sequence
A CpG-containing oligodeoxynucleotide (CpG-ODN) consisting of the sequence of SEQ ID NO: 4.
Alum adjuvant included
An alum adjuvant included in the immunogenic composition.
Neutralizing antibodies induced after intramuscular immunization
The immunogenic composition induces neutralizing antibodies against SARS-CoV-2 in a subject immunized intramuscularly.
No antibody-dependent enhancement
The immunogenic composition does not induce antibody-dependent enhancement of SARS-CoV-2-associated disease.
Producing and inactivating SARS-CoV-2 whole virus particles, then incorporating into CpG-ODN and alum
A method of producing a SARS-CoV-2 immunogenic composition comprising producing SARS-CoV-2 whole virus particles having an S protein with at least 96% amino acid sequence identity to SEQ ID NO: 3, inactivating the particles, and incorporating the inactivated particles in an immunogenic composition comprising the CpG-ODN and an alum adjuvant.
Across the independent claims, the scope centers on an inactivated SARS-CoV-2 whole virus particle with defined S protein sequence identity, combined with a CpG-ODN consisting of SEQ ID NO: 4 and an alum adjuvant, where intramuscular immunization induces neutralizing antibodies without inducing antibody-dependent enhancement.
Stated Advantages
Induces neutralizing antibodies against SARS-CoV-2.
Does not induce antibody-dependent enhancement of SARS-CoV-2-associated disease.
Highly immunogenic, with >90% seroconversion across groups.
No major safety concerns identified by an independent DSMB.
Reduces risk of Th2-driven immunopathology.
Preserves native spike epitopes via mild inactivation.
Documented Applications
Phase-study evaluation in dose groups (low/medium/high) with safety and immunogenicity outcomes through Day 36 for a SARS-CoV-2 vaccine candidate.
Use of the immunogenic composition to immunize subjects intramuscularly to induce neutralizing antibodies.
Kit use cases including configuration with a second immunogenic composition for Japanese encephalitis virus, Zika virus, Dengue virus, influenza virus, or Chikungunya virus as part of an enumerated kit aspect.
Preclinical immunogenicity/neutralization and ADE/immunopathology testing, together with Phase 1/2 clinical safety and immunogenicity readouts (neutralizing antibodies, IgG ELISA, and IFN-γ T-cell responses) for an alum-adjuvanted inactivated whole SARS-CoV-2 vaccine formulated with CpG 1018.
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