Chemistry: molecular biology and microbiology – Micro-organism – tissue cell culture or enzyme using process... – Recombinant dna technique included in method of making a...
Reexamination Certificate
2000-02-02
2001-06-19
Park, Hankyel T. (Department: 1648)
Chemistry: molecular biology and microbiology
Micro-organism, tissue cell culture or enzyme using process...
Recombinant dna technique included in method of making a...
C424S185100, C424S192100, C514S04400A, C530S350000, C536S023400, C536S023500
Reexamination Certificate
active
06248565
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to improved protective and therapeutic vaccines and improved methods for prophylactically and/or therapeutically inducing immune responses against antigens.
BACKGROUND OF THE INVENTION
DNA vaccines represent an emerging field which provides the means to prevent and treat disorders, diseases, conditions and infections by inducing immune responses in individuals which are directed at antigens associated with such disorders, diseases, conditions and infections. Essentially, plasmid DNA that includes coding sequences for antigens operably linked to regulatory elements required for gene expression is administered to individuals. The cells of the individual take up the plasmid DNA and the coding sequence is expressed. The antigen so produced becomes a target against which an immune response is directed. The immune response directed against the antigen provided the prophylactic or therapeutic benefit to the individual against any allergen, pathogen, cancer cell or autoimmune cell that includes an epitope that is recognized by the immune response against the antigen.
DNA vaccines include naked and facilitated vaccines. Further, they may be administered by a variety of techniques including several different devices for administering substances to tissue. The published literature includes several review articles that describe aspects of DNA vaccine technology and cite some of the many reports of results obtained using the technology. The following review articles which are each incorporated herein by reference as are each of the references cited in each review article discuss DNA vaccine technology: McDonnel W. M and F. K. Askari 1996 New Engl. J. Med. 334(1)42-45; Robinson, A. 1995 Can. Med. Assoc. J. 152(10):1629-1632; Fynan, E. F. et al. 1995 Int. J. Immunopharmac. 17(2)79-83; Pardoll, D. M. and A. M. Beckerleg 1995 Immunity 3:165-169; and Spooner et al. 1995 Gene Therapy 2:173-180.
While such vaccines are often effective to immunize individuals prophylactically or therapeutically against pathogen infection or human diseases, there is a need for improved vaccines. There is a need for compositions and methods which produce an enhanced immune response.
SUMMARY OF THE INVENTION
The present invention relates to a plasmid which comprises nucleotide sequences that encodes an immunogenic target antigen operably linked to regulatory elements necessary for expression in eukaryotic cells wherein the nucleotide sequence that encodes the immunogenic antigen includes a nucleotide sequence that encodes a signal sequence which directs trafficking of the immunogenic target antigen within the cell. In some preferred embodiments, the immunogenic target antigen is a pathogen antigen, a cancer-associated antigen or an antigen linked to cells associated with autoimmune diseases. In some embodiments, the nucleotide sequence that encodes a signal sequence which directs trafficking of the immunogenic target antigen within the cell encodes a signal sequence which directs the immunogenic target antigen to be secreted or to localize to the cytoplasm, the cell membrane, the endoplasmic reticulum, or a lysosome. In some embodiments, the nucleotide sequence that encodes a signal sequence which directs intracellular trafficking of the immunogenic target antigen is a non-native signal sequence.
The present invention relates to a method of inducing, in an individual, an immune response against an antigen comprising the step of administering to an individual, a plasmid which comprises a nucleotide sequence that encodes an immunogenic target antigen operably linked to regulatory elements necessary for expression in eukaryotic cells wherein the nucleotide sequence that encodes the immunogenic antigen includes a nucleotide sequence that encodes a signal sequence which directs trafficking of the immunogenic target antigen within the cell. In some preferred embodiments, the immunogenic target antigen is a pathogen antigen, a cancer-associated antigen or an antigen linked to cells associated with autoimmune diseases. In some embodiments, the nucleotide sequence that encodes a signal sequence which directs trafficking of the immunogenic target antigen within the cell encodes a signal sequence which directs the immunogenic target antigen to be secreted or to localize to the cytoplasm, the cell membrane, the endoplasmic reticulum, or a lysosome. In some embodiments, the nucleotide sequence that encodes a signal sequence which directs intracellular trafficking of the immunogenic target antigen is a non-native signal sequence.
The present invention relates to improved DNA vaccines which comprises nucleotide sequences that encodes an immunogenic target antigen operably linked to regulatory elements necessary for expression in eukaryotic cells wherein the nucleotide sequence that encodes the immunogenic antigen includes a nucleotide sequence that encodes a signal sequence which directs trafficking of the immunogenic target antigen within the cell. In some preferred embodiments, the immunogenic target antigen is a pathogen antigen, a cancer-associated antigen or an antigen linked to cells associated with autoimmune diseases. In some embodiments, the nucleotide sequence that encodes a signal sequence which directs trafficking of the immunogenic target antigen within the cell encodes a signal sequence which directs the immunogenic target antigen to be secreted or to localize to the cytoplasm, the cell membrane, the endoplasmic reticulum, or a lysosome. In some embodiments, the nucleotide sequence that encodes a signal sequence which directs intracellular trafficking of the immunogenic target antigen is a non-native signal sequence.
The present invention relates to a method of immunizing an individual against a pathogen, cancer or an autoimmune disease comprising the step of administering to an individual, a DNA vaccine which comprises a nucleotide sequence that encodes an immunogenic target antigen operably linked to regulatory elements necessary for expression in eukaryotic cells wherein the nucleotide sequence that encodes the immunogenic antigen includes a nucleotide sequence that encodes a signal sequence which directs trafficking of the immunogenic target antigen within the cell. In some preferred embodiments, the immunogenic target antigen is a pathogen antigen, a cancer-associated antigen or an antigen linked to cells associated with autoimmune diseases. In some embodiments, the nucleotide sequence that encodes a signal sequence which directs trafficking of the immunogenic target antigen within the cell encodes a signal sequence which directs the immunogenic target antigen to be secreted or to localize to the cytoplasm, the cell membrane, the endoplasmic reticulum, or a lysosome. In some embodiments, the nucleotide sequence that encodes a signal sequence which directs intracellular trafficking of the immunogenic target antigen is a non-native signal sequence.
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Fy
Madaio Michael
Weiner David B.
Williams William V.
Park Hankyel T.
The Trustees of the University of Pennsylvania
Woodcock Washburn Kurtz Mackiewicz & Norris LLP
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