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Publication Number
US-10588956-B2
Publication Date
2020-03-17
Expiration Date
Abstract
The present disclosure provides vaccine compositions for prophylaxis and treatment of Zika virus infections comprising Zika virus antigens in immunogenic compositions, and in combination of Zika antigens with one or more arbovirus antigens such as Chikungunya virus and Japanese encephalitis virus antigens, methods of preparation and production of such compositions for use as vaccines for eliciting immune response in mammals against the above mentioned pathogens.
Core Innovation
The invention relates to immunogenic compositions comprising an antigen obtained or derived from a Zika virus together with a pharmaceutically acceptable buffer. The antigen is rendered non-infectious through a non-natural inactivation, and the composition elicits a protective immune response to Zika virus in mammals. The disclosed compositions include monovalent Zika formulations and combination arbovirus vaccines that pair Zika with Chikungunya and/or Japanese encephalitis.
The disclosed antigen composition includes one or more of Zika virus envelope (E) protein, membrane (M) protein, and non-structural 1 (NS1) protein, and antigens can contain the amino acid sequence of SEQ ID NO 3 and/or SEQ ID NO 4. The disclosure also encompasses recombinantly engineered antigens obtained or derived from nucleic acid of a Zika virus, including antigen expression as virus-like particles.
The disclosure further centers on formulation and product stability for immunogenic delivery. The compositions provide pharmaceutically acceptable buffers and can include stabilizing agents during non-natural inactivation, and broad adjuvant classes with aluminum hydroxide as a notable example. The document also discusses results showing protective immunity and immunological effects, including neutralizing antibodies and cross-neutralization across Zika strains/genotypes.
Claims Coverage
The document includes three independent claims covering three inventive features: non-naturally inactivated Zika antigen in a pharmaceutically acceptable buffer, stable recombinantly engineered Zika antigen in a pharmaceutically acceptable buffer, and Zika antigen containing SEQ ID NO 3 and/or SEQ ID NO 4 with non-natural inactivation and/or recombinant engineering.
Non-naturally inactivated Zika antigen in a pharmaceutically acceptable buffer
An immunogenic composition comprising an antigen obtained or derived from a Zika virus, and a pharmaceutically acceptable buffer, wherein the antigen is rendered non-infectious through a non-natural inactivation, and wherein the composition elicits a protective immune response to Zika virus in mammals.
Recombinantly engineered Zika antigen in a pharmaceutically acceptable buffer
A stable immunogenic composition comprising a recombinantly engineered antigen obtained or derived from nucleic acid of a Zika virus, and a pharmaceutically acceptable buffer, wherein the composition elicits a protective immune response to infection by Zika virus in mammals.
SEQ ID NO 3 and/or SEQ ID NO 4 antigen with non-infectious and/or recombinantly engineered Zika antigen
An immunogenic composition comprising an antigen obtained or derived from a Zika virus, and a pharmaceutically acceptable buffer, wherein said antigen is rendered non-infectious through non-natural inactivation and/or is recombinantly engineered from the nucleic acid of a Zika virus; and said antigen contains the amino acid sequence of SEQ ID NO 3 and/or SEQ ID NO 4.
Across the independent claims, protection in mammals is linked to a Zika virus-derived antigen rendered non-infectious via non-natural inactivation, a stable composition using a recombinantly engineered Zika antigen derived from nucleic acid, and compositions where the antigen contains the amino acid sequence of SEQ ID NO 3 and/or SEQ ID NO 4 while allowing either non-natural inactivation and/or recombinant engineering.
Stated Advantages
Elicits a protective immune response to Zika virus in mammals.
Elicits a protective immune response to infection by Zika virus in mammals.
Protective immunity is supported in animal challenge context by complete protection from viremia (as reported in the disclosure).
Induces high neutralizing antibody titers (as reported in the disclosure).
Supports cross-neutralization across Zika strains/genotypes (as reported in the disclosure).
Increases antibody avidity/quality (as reported in the disclosure).
Allows immune response profiling (Th1/Th2 cytokine profiles depending on adjuvant; as reported in the disclosure).
The disclosure states a lack of antigenic interference in combination vaccines.
Documented Applications
Combination arbovirus vaccination using Zika with Chikungunya and/or Japanese encephalitis to elicit protective immunity in mammals (as disclosed).
Immunodiagnostic and immunotherapeutic use of Zika antibodies (as discussed in the disclosure).
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