Immunogenicity of a CpG-adjuvanted recombinant plague vaccine
AssigneesDynavax Technologies Corporation, The Government of the United States, as represented by the Secretary of the Army
InventorsRobert S. Janssen, David Novack, Wai Kwan Chung, Andrew M. Glenn, Lucy A. Ward
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Abstract
The present disclosure relates to immunogenic compositions comprising at least one Yersinia pestis (Y. pestis) antigen, an aluminum salt adjuvant, and an oligonucleotide comprising an unmethylated cytidine-phospho-guanosine (CpG) motif. The immunogenic compositions are suitable for stimulating an immune response against Y. pestis in a subject in need thereof. The present disclosure also relates to kits and methods using the immunogenic compositions, or two separate compositions which together comprise the antigen, the aluminum salt adjuvant, and the oligonucleotide.
Claims15
An immunogenic composition comprising:
- (i) an unmethylated cytidine-phospho-guanosine (CpG)-containing oligonucleotide comprising the sequence of 5′-TGACTGTGAA CGTTCGAGAT GA-3′ (SEQ ID NO:1);
- (ii) at least one Yersinia pestis (Y. pestis) antigen;
- and
- (iii) an aluminum salt adjuvant,
- wherein the one dose of the immunogenic composition comprises the Y. pestis antigen in an amount of about 160 mcg, the oligonucleotide in an amount of about 3000 mcg, and the aluminum salt adjuvant in an amount of about 750 mcg Al3+.
A vial comprising an immunogenic composition comprising:
- (i) an unmethylated cytidine-phospho-guanosine (CpG)-containing oligonucleotide comprising the sequence of 5′-TGACTGTGAA CGTTCGAGAT GA-3′ (SEQ ID NO:1);
- (ii) at least one Yersinia pestis (Y. pestis) antigen;
- and
- (iii) an aluminum salt adjuvant,
- wherein the one dose of the immunogenic composition comprises the Y. pestis antigen in an amount of about 160 mcg, the oligonucleotide in an amount of about 3000 mcg, and the aluminum salt adjuvant in an amount of about 750 mcg Al3+.
A pre-filled syringe comprising an immunogenic composition comprising:
- (i) an unmethylated cytidine-phospho-guanosine (CpG)-containing oligonucleotide comprising the sequence of 5′-TGACTGTGAA CGTTCGAGAT GA-3′ (SEQ ID NO:1);
- (ii) at least one Yersinia pestis (Y. pestis) antigen;
- and
- (iii) an aluminum salt adjuvant,
- wherein the one dose of the immunogenic composition comprises the Y. pestis antigen in an amount of about 160 mcg, the oligonucleotide in an amount of about 3000 mcg, and the aluminum salt adjuvant in an amount of about 750 mcg Al3+.
A kit comprising:
- a) a first composition comprising an unmethylated cytidine-phospho-guanosine (CpG)-containing oligonucleotide comprising the sequence of 5′-TGACTGTGAA CGTTCGAGAT GA-3′ (SEQ ID NO:1);
- b) a second composition comprising at least one Y. pestis antigen and an aluminum salt adjuvant;
- and
- c) instructions for combining the first composition and the second composition to prepare an immunogenic composition, wherein the one dose of the immunogenic composition comprises the Y. pestis antigen in an amount of about 160 mcg, the oligonucleotide in an amount of about 3000 mcg, and the aluminum salt adjuvant in an amount of about 750 mcg Al3+.
A kit comprising:
- a) a first composition comprising an unmethylated cytidine-phospho-guanosine (CpG)-containing oligonucleotide comprising the sequence of 5′-TGACTGTGAA CGTTCGAGAT GA-3′ (SEQ ID NO:1);
- b) a second composition comprising at least one Y. pestis antigen and an aluminum salt adjuvant;
- and
- c) instructions for separate administration of the first and second compositions to a subject to stimulate an immune response against Y. pestis in the subject;
- wherein the subject is to administered the Y. pestis antigen in an amount of about 160 mcg, the oligonucleotide in an amount of about 3000 mcg, and the aluminum salt adjuvant in an amount of about 750 mcg Al3+.
Dependencies are inferred from the claim text.