CHLOROPLASTS ENGINEERED TO EXPRESS PHARMACEUTICAL PROTEINS
Vaccines for conferring immunity in mammals to infective pathogens are provided, as well as vectors and methods for plastid transformation of plants to produce protective antigens and vaccines for oral delivery. The vaccines are operative by parenteral administration as well. The invention also extends to the transformed plants, plant parts, and seeds and progeny thereof. The invention is applicable to monocot and dicot plants.
1 - 85 . (canceled)
86 . A method of inducing, in a subject in need thereof, serum antibodies which protect against infection with rotavirus, comprising administering to said subject, a composition comprising CTB-NSP4 fusion protein and a plant remnant.
87 . The method of claim 86 for the treatment of severe diarrheal illness in infants and young children.
88 . A method for vaccinating a human against rotavirus infection, comprising administering to the human an immunizing amount of a composition comprising CTB-NSP4 fusion protein, wherein said CTB-NSP4 fusion protein is derived from a plant transformed to express CTB-NSP4 in the chloroplasts thereof.
89 . A vaccine composition for use in the method of claim 88 comprising CTB-NSP4, a plant remnant and a biologically acceptable carrier, said vaccine being effective for treating severe diarrheal illness in infants and young children associated with rotavirus infection.
90 . A stable plastid transformation and expression vector which comprises an expression cassette comprising, as operably linked components in the 5′ to the 3′ direction of translation, a promoter operative in said plastid, a selectable marker sequence, a heterologous polynucleotide sequence encoding a rotavirus NSP4 protein antigen protein operably linked to a sequence encoding CTB, a transcription termination functional in said plastid, and flanking each side of the expression cassette, flanking DNA sequences which are homologous to a DNA sequence of the target plastid genome, whereby stable integration of the heterologous coding sequence into the plastid genome of the target plant is facilitated through homologous recombination of the flanking sequence with the homologous sequences in the target plastid genome.
91 . A transformed plant comprising the vector of claim 90 .