Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing
Reexamination Certificate
2000-04-28
2004-08-24
Navarro, Mark (Department: 1645)
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
C424S093200, C424S093400, C424S200100, C435S252300, C435S320100
Reexamination Certificate
active
06780405
ABSTRACT:
BACKGROUND OF THE INVENTION
(1) Field of the Invention
The invention relates to materials and methods for preparing vaccines and recombinant DNA expression products, and more particularly to genetically engineered attenuated pathogenic microorganisms that are useful for expressing antigens and other recombinant products encoded on plasmid-borne genes.
(2) Description of the Related Art
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Related Art
Genetically engineered microorganisms have widespread utility and importance. One important use of these microorganisms is as live vaccines to produce an immune response. Live vaccines are most effective when they produce high levels of antigen. However, the synthesis of a high level expression of a recombinant antigen may be deleterious to the microorganism. Because of this, regulated (as opposed to constitutive) expression systems have been identified and utilized where the recombinant gene of interest is operably linked to control elements that allow expression of significant amounts of the recombinant gene only when it is induced, derepressed or activated. Examples include the cspA gene promoter, the phoA gene promoter, P
BAD
(in an araC-P
BAD
system), the trp promoter, the tac promoter, the trc promoter, &lgr;P
L
, P22 P
R
, mal promoters, and the lac promoter. These promoters mediate transcription at low temperature, at low phosphate levels, in the presence of arabinose, in the presence of at low tryptophan levels, and in the presence of lactose (or other lac inducers.
One important use of genetically engineered microorganisms is as a live vaccine for inducing immunity. See, e.g., U.S. Pat. Nos. 6,024,961; 4,888,170; 5,389,368; 5,855,879; 5,855,880; 5,294,441; 5,468,485; 5,387,744; 5,840,483, 5,672,345; 5,424,065; 5,378,744; 5,888,790; 5,424,065; 5,656,488; 5,006,335; 5,643,771; 5,980,907; 5,851,519; and 5,527,529, all of which are incorporated by reference. When the genetically engineered microorganism is to be utilized as a vertebrate live vaccine, certain considerations must be taken into account. To provide a benefit beyond that of a nonliving vaccine, the live vaccine microorganism must attach to, invade, and survive in lymphoid tissues of the vertebrate and expose these immune effector sites in the vertebrate to antigen for an extended period of time. By this continual stimulation, the vertebrate's immune system becomes more highly reactive to the antigen than with a nonliving vaccine. Therefore, preferred live vaccines are attenuated pathogens of the vertebrate, particularly pathogens that colonize the gut-associated lymphoid tissue (GALT) or bronchial-associated lymphoid tissue (BALT). An additional advantage of these attenuated pathogens over nonliving vaccines is that these pathogens have elaborate mechanisms to gain access to lymphoid tissues, and thus efficient exposure to the vertebrate's immune system can be expected. In contrast, nonliving vaccines will only provide an immune stimulus if the vaccine is passively exposed to the immune system, or if host mechanisms bring the vaccine to the immune system.
As described in U.S. Pat. No. 5,888,799, for example, pathogenic bacteria can be attenuated by introduction of mutations so that upon infection of an animal host disease symptomology is not elicited, yet the bacteria retain the ability to attach to, invade, and colonize lymphoid tissues within the animal host for a sufficient time to induce an immune response against the attenuated bacteria. These attenuated bacterial vaccine strains can be genetically engineered to express foreign antigens encoded by genes on plasmid vectors or inserted into the chromosome that are derived from heterologous pathogenic bacteria, viruses, fungi, or parasites. These recombinant attenuated bacterial vaccines can be delivered as live vaccines to mucosal surfaces in an immunized individual so that the recombinant bacteria serve as a factory within these lymphoid tissues of the immunized vertebrate, producing the foreign antigen and eliciting a primary and/or protective immune response enabling the immunized animal host to survive infection by the pathogen whose antigen is expressed by the recombinant attenuated bacterial vaccine.
Bacteria can be attenuated by introducing mutations that permit environmental regulation of surface molecule synthesis such as lipopolysaccharides in gram-negative microorganisms as affected by a gale mutation (U.S. Pat. No. 5,006,335). Bacteria can also be attenuated by introduction of mutations that impose specific nutritional requirements, such as for constituents of nucleic acids such as purines, constituents of the cell wall such as diaminopimelic acid (LAP) (U.S. Pat. No. 4,888,170), or that impose requirements for aromatic amino acids and vitamins derived therefrom, such as caused by aro mutations (U.S. Pat. No. 5,643,771). Still other means of attenuation are achieved by mutating genes affecting global regulation of other genes. Thus mutants with mutations in the genes for adenylate cyclase, cya, and the cAMP receptor protein, crp, are attenuated and immunogenic (U.S. Pat. Nos. 5,294,441; 5,389,368; 5,468,485; 5,855,879 and 5,855,880). Similarly, mutations in the phoPQ two-component regulatory system (U.S. Pat. No. 5,424,065) and mutations such as ompR U.S. Pat. No. 5,527,529), hemA Benjamin et al., 1991,
Microb. Pathog.
11:289-295), and htrA (U.S. Pat. No. 5,980,907) have also
Curtiss III Roy
Tinge Steven A.
Avant Immunotherapeutics, Inc.
Navarro Mark
Wesolowski Michael R.
Yankwich Leon R.
Yankwich & Associates
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