US2008299151A1PendingUtilityA1

Influenza vaccines

55
Assignee: STATENS SERUMINSTITUTPriority: May 31, 2007Filed: May 30, 2008Published: Dec 4, 2008
Est. expiryMay 31, 2027(~0.9 yrs left)· nominal 20-yr term from priority
Inventors:Anders Fomsgaard
C12N 2760/16134A61K 39/12A61K 2039/70A61K 39/145A61K 2039/54A61P 31/12A61K 2039/53
55
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Claims

Abstract

Described herein are vaccines and the use of naked DNA and/or RNA encoding hemagglutinin (HA) from pandemic influenza, e.g., the 1918 H1N1 and/or the 1957 H2N2 and/or the 1968 H3N2 influenza A virus, as a vaccine component against present day and coming H1, H2, H3, H5, N1, N2 containing influenza A infections in humans and swine optionally with the naked DNA and/or RNA encoding Neuraminidase (NA) and/or matrix protein (M) and/or the nucleoprotein (NP) from pandemic influenza virus included. If the vaccine components are used as DNA or RNA vaccines with or without the corresponding protein, the codons can optionally be “humanized” using preferred codons from highly expressed mammalian genes and the administration of this DNA vaccine can be by saline or buffered saline injection of naked DNA or RNA, or injection of DNA plasmid or linear gene expressing DNA fragments coupled to particles. Addition of the matrix protein (M) and/or the nucleoprotein (NP) from the 1918 influenza strain is also disclosed.

Claims

exact text as granted — not AI-modified
1 . A method of treating or preventing infection with a H1, H2, H3 containing influenza A in a subject, said method comprising delivering to the subject a naked DNA and/or RNA molecule encoding hemagglutinin (HA) from pandemic influenza selected from one or more of the 1918 H1N1, the 1957 H2N2, and the 1968 H3N2 influenza A virus. 
     
     
         2 . The method according to  claim 1 , wherein the method comprises administering a vaccine for N1, N2 containing influenza A in humans or swine, the method further comprising delivering to the subject a naked DNA and/or RNA molecule encoding neuraminidase (NA) and/or matrix protein (M) and/or the nucleoprotein (NP) from a pandemic influenza virus therapeutically or prophylactically. 
     
     
         3 . The method according to  claim 1 , wherein the codons of the DNA or RNA are humanized using codons of highly expressed human proteins. 
     
     
         4 . The method according to  claim 1 , further comprising delivering an adjuvant to the subject. 
     
     
         5 . The method according to  claim 1 , where a DNA vaccine is administered by saline injection of naked DNA and/or RNA, inoculated by gene gun or is delivered coupled to particles. 
     
     
         6 . A vaccine for human use comprising a naked DNA and/or RNA molecule encoding hemagglutinin (HA) from a pandemic influenza selected from the group consisting of the 1918 H1N1, the 1957 H2N2, and the 1968 H3N2 influenza A virus. 
     
     
         7 . The vaccine according to  claim 6 , further comprising a naked DNA and/or RNA molecule encoding neuraminidase (NA) and/or matrix protein (M) and/or the nucleoprotein (NP) from a pandemic influenza virus. 
     
     
         8 . The vaccine according to  claim 6 , wherein the vaccine consists of as its antigenic component the HA and one or more of a neuraminidase (NA), a matrix (M) protein, and/or nucleoprotein (NP). 
     
     
         9 . The vaccine according to  claim 6 , where the vaccine consists of as its antigenic component naked DNA or RNA molecule coding for the HA and one or more of a neuraminidase (NA) protein, matrix protein, and/or nucleoprotein (NP). 
     
     
         10 . The vaccine according to  claim 9 , where the DNA or RNA codons are humanized using codons of highly expressed human proteins. 
     
     
         11 . The vaccine according to  claim 6 , wherein the vaccine further comprises an adjuvant. 
     
     
         12 . The vaccine according to  claim 6 , where the vaccines are administered therapeutically to already infected humans or swine. 
     
     
         13 . A method of treating or preventing infection with H5, H7 or H2 containing influenza A in a subject, said method comprising delivering to the subject a naked DNA and/or RNA molecule encoding hemagglutinin (HA) and/or neuraminidase (NA) from an influenza strain selected from the group consisting of a 2001 H5N7 low pathogenic Avian influenza virus (AIV) strain (A/Mallard/Denmark/64650/03(H5N7)) and a March 2006 Denmark H5N1 high pathogenic AIV strain (A/buzzard/Denmark/6370/06(H5N1)). 
     
     
         14 . The method according to  claim 13 , wherein the naked DNA and/or RNA molecule encoding HA or NA are delivered in a composition containing the HA and/or NA proteins. 
     
     
         15 . The method according to  claim 13 , wherein the HA or NA are delivered in a composition containing the naked DNA and/or RNA molecule encoding the HA and/or NA proteins. 
     
     
         16 . The method according to  claim 15 , where the DNA or RNA codons are humanized. 
     
     
         17 . A vaccine for preventing infection with H5, H7 or H2 containing influenza A infections in humans or swine comprising a naked DNA and/or RNA molecule encoding hemagglutinin (HA) and/or neuraminidase (NA) from an influenza strain selected from the group consisting of 2001 H5N7 low pathogenic Avian influenza virus (AIV) strain (A/Mallard/Denmark/64650/03(H5N7)), March 2006 Denmark H5N1 high pathogenic AIV strain (A/buzzard/Denmark/6370/06(H5N 1)), (A/duck/Denmark/53-147-8/08 (H7N1)) and (A/widegeon/Denmark/66174/G18/04 (H2N3)). 
     
     
         18 . The vaccine according to  claim 17 , wherein the vaccine comprises naked DNA and/or RNA molecules encoding the HA or NA proteins. 
     
     
         19 . The vaccine according to  claim 17 , where the DNA or RNA codons are humanized. 
     
     
         20 . The vaccine according to  claim 17 , wherein the vaccine further comprises an adjuvant.

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