Application US20160331828

NUCLEIC ACID VACCINES
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US20160331828

1-56. (canceled) (0)

57. A nucleic acid vaccine, comprising: (20) (1)

one or more RNA polynucleotides having an open reading frame encoding a hemagglutinin protein selected from HA1, HA7 and HA10 wherein the hemagglutinin protein is derived from a strain of Influenza A virus, wherein the RNA polynucleotide includes a chemical modification and a pharmaceutically acceptable carrier or excipient, formulated within a cationic lipid nanoparticle.

59. The vaccine of claim 57, wherein the RNA polynucleotide does not encode F protein. (0)

60. The vaccine of claim 57, wherein the RNA polynucleotide further encodes neuraminidase protein. (0)

64. The vaccine of claim 57 wherein the chemical modification selected from the group consisting of pseudouridine, N1-methylpseudouridine, 2-thiouridine, 4′-thiouridine, 5-methylcytosine, 2-thio-1-methyl-1-deaza-pseudouridine, 2-thio-1-methyl-pseudouridine, 2-thio-5-aza-uridine, 2-thio-dihydropseudouridine, 2-thio-dihydrouridine, 2-thio-pseudouridine, 4-methoxy-2-thio-pseudouridine, 4-methoxy-pseudouridine, 4-thio-1-methyl-pseudouridine, 4-thio-pseudouridine, 5-aza-uridine, dihydropseudouridine, 5-methoxyuridine, and 2′-O-methyl uridine. (0)

67. The vaccine of claim 57, wherein the cationic lipid nanoparticle comprises a cationic lipid, a PEG-modified lipid, a sterol and a non-cationic lipid. (2) (0)

70. The vaccine of claim 57, wherein the RNA polynucleotide comprises at least one of SEQ ID Nos 2254-2258. (0)

71. The vaccine of claim 57, wherein the RNA polynucleotide comprises a polynucleotide having at least 80% sequence identity to at least one of SEQ ID NOs 2254-2258. (0)

72. The vaccine of claim 57, wherein the RNA polynucleotide comprises a polynucleotide encoding an amino acid sequence having at least 90% sequence identity to SEQ ID NO 2254. (0)

73. The vaccine of claim 57, wherein the RNA polynucleotide comprises a polynucleotide encoding the amino acid sequence of SEQ ID NO 2254. (0)

74. The vaccine of claim 57, wherein the RNA polynucleotide comprises a polynucleotide encoding an amino acid sequence having at least 90% sequence identity to SEQ ID NO 2259. (0)

75. The vaccine of claim 57, wherein the RNA polynucleotide comprises a polynucleotide encoding the amino acid sequence of SEQ ID NO 2259. (0)

78. The vaccine of claim 57, wherein the RNA polynucleotide comprises a polynucleotide encoding an amino acid sequence having at least 90% sequence identity to at least one of SEQ ID NO 2200, 2259-2263. (0)

79. The vaccine of claim 57, wherein the RNA polynucleotide comprises a polynucleotide encoding the amino acid sequence of at least one of SEQ ID NO 2200, 2259-2263. (0)

81. The vaccine of claim 57, wherein the RNA polynucleotide comprises a polynucleotide having 80-98% sequence identity to SEQ ID NO 2624. (0)

88. The vaccine of claim 57, wherein the RNA polynucleotide comprises 80-95% sequence identity to SEQ ID NO 2623. (0)

89. The vaccine of claim 57, wherein the RNA polynucleotide comprises SEQ ID NO: 2624. (0)

90. A method of inducing an antigen specific immune response in a subject, comprising administering a vaccine of claim 57 to the subject in an effective amount to produce an antigen specific immune response. (1) (0)

132. The vaccine of claim 57, wherein the hemagglutinin protein includes only a portion of at least one of: a head domain (HA1), a cytoplasmic domain, or a transmembrane domain. (3) (0)

136. The vaccine of claim 57, wherein the cationic lipid nanoparticle comprises a molar ratio of about 45-65% cationic lipid, about 0.15-15% PEG lipid, about 15-45% cholesterol and about 5-25% non-cationic lipid. (0)

137. The vaccine of claim 57, wherein the open reading frame is codon-optimized. (0)

138. The vaccine of claim 57, wherein the hemagglutinin protein is H1, H2, H3, H4, H5, H6, H7, H8, H9, H10, H11, H12, H13, H14, H15, H16, H17, H18, or a fragment thereof. (0)

58. (canceled) (0)

61. (canceled) (1) (0)

63. (canceled) (0)

65-66. (canceled) (0)

76-77. (canceled) (0)

80. (canceled) (0)

82-87. (canceled) (0)

91-92. (canceled) (0)

94-104. (canceled) (0)

105. A method of vaccinating a subject comprising administering to the subject a nucleic acid vaccine comprising one RNA polynucleotides having a single open reading frame encoding a hemagglutinin polypeptide, wherein the RNA polynucleotide does not include a stabilization element, and wherein an adjuvant is not coformulated or co-administered with the vaccine. (1) (0)

107-131. (canceled) (0)

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Application US20160331828

NUCLEIC ACID VACCINES

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