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US20030044421: Enhanced first generation adenovirus vaccines expressing codon optimized HIV1-Gag, Pol, Nef and modifications

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Filing Information

Inventor(s) Rima Youil · Andrew Bett · Ling Chen · David Kaslow · John Shiver · Timothy Toner · Danilo Casimiro · Emilio Emini ·
Assignee(s) None listed in document.
Correspondent MERCK AND CO INC ·
Application Number US9952060
Filing date 09/14/2001
Publication date 03/06/2003
Predicted expiration date 09/14/2021
U.S. Classifications 424/187.1  · 435/320.1  · 435/456  · 435/235.1  · 514/44  ·
International Classifications A01N043/04  · A61K031/70  · A61K039/21  · A61K048/00  · C12N007/00  · C12N007/01  · C12N015/00  · C12N015/09  · C12N015/63  · C12N015/70  · C12N015/74  · C12N015/86  · C12N015/861  ·
Kind CodeA1
Related U.S. Application DataCROSS-REFERENCE TO RELATED APPLICATIONS
0001 This application claims the benefit, under 35 U.S.C. §119(e), of U.S. provisional applications 60/233,180, 601279,056, and Attorney Docket 20867PV2 (serial number unassigned), filed Sep. 15, 2000, Mar. 27, 2001, and Sep. 7, 2001, respectively.
89 Claims, 144 Drawings


Abstract

First generation adenoviral vectors and associated recombinant adenovirus-based HIV vaccines which show enhanced stability and growth properties and greater cellular-mediated immunity are described within this specification. These adenoviral vectors are utilized to generate and produce through cell culture various adenoviral-based HIV-1 vaccines which contain HIV-1 gag, HIV-1 pol and/or HIV-1 nef polynucleotide pharmaceutical products, and biologically relevant modifications thereof. These adenovirus vaccines, when directly introduced into living vertebrate tissue, preferably a mammalian host such as a human or a non-human mammal of commercial or domestic veterinary importance, express the HIV1-Gag, Pol and/or Nef protein or biologically modification thereof, inducing a cellular immune response which specifically recognizes HIV-1. The exemplified polynucleotides of the present invention are synthetic DNA molecules encoding HIV-1 Gag, encoding codon optimized HIV-1 Pol, derivatives of optimized HIV-1 Pol (including constructs wherein protease, reverse transcriptase, RNAse H and integrase activity of HIV-1 Pol is inactivated), HIV-1 Nef and derivatives of optimized HIV-1 Nef, including nef mutants which effect wild type characteristics of Nef, such as myristylation and down regulation of host CD4. The adenoviral vaccines of the present invention, when administered alone or in a combined modality regime, will offer a prophylactic advantage to previously uninfected individuals and/or provide a therapeutic effect by reducing viral load levels within an infected individual, thus prolonging the asymptomatic phase of HIV-1 infection.

Independent Claims | See all claims (89)

  1. 1. A recombinant adenoviral vaccine vector at least partially deleted in E1 and devoid of E1 activity, comprising: a) an adenovirus cis-acting packaging region corresponding to from about base pair 1 to between from about base pair 400 to about base pair 458 of a wildtype adenovirus genome; and b) a gene encoding an HIV protein or immunologically relevant modification thereof.
  2. 31. A recombinant adenoviral vaccine vector at least partially deleted in E1 and devoid of E1 activity, comprising: a) an adenovirus cis-acting packaging region corresponding to from about base pair 1 to about base pair 450 and from about 3511 to about 5798 of a wildtype adenovirus genome, and deleted for base pairs corresponding to from about base pair 451 to from about base pair 3510 of a wildtype adenovirus genome; and b) a gene expression cassette comprising i) SEQ ID NO:29; ii) a heterologous promoter operatively linked to i); and iii) a transcription termination sequence.
  3. 50. A recombinant adenoviral vaccine vector at least partially deleted in E1 and devoid of E1 activity, comprising: a) an adenovirus cis-acting packaging region corresponding to from about base pair 1 to about base pair 450 and from about 3511 to about 5798 of a wildtype adenovirus genome, and deleted for base pairs corresponding to from about base pair 451 to from about base pair 3510 of a wildtype adenovirus genome; and b) a gene expression cassette comprising i) a nucleotide sequence selected the group consisting of SEQ ID NO:1, SEQ ID NO:5 and SEQ ID NO:7; ii) a heterologous promoter operatively linked to i); and iii) a transcription termination sequence.
  4. 69. A recombinant adenoviral vaccine vector at least partially deleted in E1 and devoid of E1 activity, comprising: a) an adenovirus cis-acting packaging region corresponding to from about base pair 1 to about base pair 450 and from about 3511 to about 5798 of a wildtype adenovirus genome, and deleted for base pairs corresponding to from about base pair 451 to from about base pair 3510 of a wildtype adenovirus genome; and b) a gene expression cassette comprising i) a nucleotide sequence selected the group consisting of SEQ ID NO:9, SEQ ID NO:11, SEQ ID NO:13 and SEQ ID NO:15; ii) a heterologous promoter operatively linked to i); and iii) a transcription termination sequence.

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Patent Family

Document NumberAssigneeInventorsIssue/Pub Date
US20030044421 Rima Youil et al. Mar 2003
US6733993 Merck & Co., Inc. Emilio A. Emini et al. May 2004
US20050070017 Emilio Emini et al. Mar 2005