The United States of America, As Represented by the Secretary, Department of Health and Human Services

The United States of America As Represented by the Secretary of

The United States of America As Represented by the Department of Health

Shousun Chen Szu

John B Robbins

Zuzana Kossaczka

Rachel Schneerson

Yvonne Ageyman Konadu, Legal Representative

Joseph Shiloach

Yvonne Ageyman Konadu

Slavomir Bystricky

Edward Konadu

Edward Konadu, Deceased

The disclosure pertains to conjugates of the capsular polysaccharide ofO139, or a structurally and/or immunologically related oligo- or poly-saccharide, and a carrier. These conjugates are useful as pharmaceutical compositions and/or vaccines to induce serum antibodies which have bactericidal (vibriocidal) activity against, in particularO139, and are useful to prevent, treat and/or reduce the severity of disease caused byinfection, such as cholera. The present disclosure also relates to diagnostic tests forinfection, and/or cholera caused byinfection, using one or more of the oligo- or poly-saccharide-carrier conjugates or antibodies described above.

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This invention relates to conjugates of the Vi polysaccharide ofwith the carrierrecombinant exoprotein A (rEPA), and compositions thereof, and to methods of using of these conjugates and/or compositions thereof for eliciting an immunogenic response in humans, including responses which provide protection against, or reduce the severity of,bacterial infections. The conjugates, and compositions thereof, are useful as vaccines to induce serum antibodies againstand are useful to prevent and/or treat illnesses caused by

This invention relates to conjugates of the O-specific polysaccharide ofO157 with a carrier, and compositions thereof, and to methods of using of using of these conjugates and/or compositions thereof for eliciting an immunogenic response in mammals, including responses which provide protection against, or reduce the severity of, bacterial infections. More particularly it relates to the use of polysaccharides containing the tetrasaccharide repeat unit: (&#x2192;3)-&#x3b1;-DGalpNAc-(1&#x2192;2)-&#x3b1;-D-PerpNAc-(1&#x2192;3)-&#x3b1;-L-Fucp-(1&#x2192;4)-&#x3b2;-D-Glcp-(1&#x2192;), and conjugates thereof, to induce serum antibodies having bactericidal (killing) activity against hemolytic-uremic syndrome (HUS) causing, in particularO157. The conjugates, and compositions thereof, are useful as vaccines to induce serum antibodies which have bactericidal or bacteriostatic activity against, in particularO157, and are useful to prevent and/or treat illnesses caused byO157. The invention further relates to the antibodies which immunoreact with the O-specific polysaccharide ofO157 and/or the carrier, that are induced by these conjugates and/or compositions thereof. The invention also relates to methods and kits using one or more of the polysaccharides, conjugates or antibodies described above.

This invention relates to conjugates of the O-specific polysaccharide ofO157 with a carrier, and compositions thereof, and to methods of using of using of these conjugates and/or compositions thereof for eliciting an immunogenic response in mammals, including responses which provide protection against, or reduce the severity of, bacterial infections. More particularly it relates to the use of polysaccharides containing the tetrasaccharide repeat unit: (&#x2192;3)-&#x3b1;-DGalpNAc-(1&#x2192;2)-&#x3b1;-D-PerpNAc-(1&#x2192;3) -&#x3b1;-L-Fucp-(1&#x2192;4)-&#x3b2;-D-Glcp-(1&#x2192;), and conjugates thereof, to induce serum antibodies having bactericidal (killing) activity against hemolytic-uremic syndrome (HUS) causing, in particularO157. The conjugates, and compositions thereof, are useful as vaccines to induce serum antibodies which have bactericidal or bacteriostatic activity against, in particularO157, and are useful to prevent and/or treat illnesses caused byO157. The invention further relates to the antibodies which immunoreact with the O-specific polysaccharide ofO157 and/or the carrier, that are induced by these conjugates and/or compositions thereof. The invention also relates to methods and kits using one or more of the polysaccharides, conjugates or antibodies described above.

The invention pertains to conjugates of the capsular polysaccharide ofO139, or a structurally and/or immunologically related oligo- or poly-saccharide, and a carrier. These conjugates are useful as pharmaceutical compositions and/or vaccines to induce serum antibodies which have bactericidal (vibriocidal) activity against, in particularO139, and are useful to prevent, treat and/or reduce the severity of disease caused byinfection, such as cholera. The present invention also relates to diagnostic tests forinfection, and/or cholera caused byinfection, using one or more of the oligo- or poly-saccharide-carrier conjugates or antibodies described above.

This invention relates to conjugates of the O-specific polysaccharide ofO157 with a carrier, and compositions thereof, and to methods of using of these conjugates and/or compositions thereof for eliciting an immunogenic response in mammals, including responses which provide protection against, or reduce the severity of, bacterial infections. More particularly it relates to the use of polysaccharides containing the tetrasaccharide repeat unit: (&#x2192;3)-&#x3b1;-DGalpNAc-(1&#x2192;2)-&#x3b1;-D-PerpNAc-(1&#x2192;3)-&#x3b1;-L-Fucp-(1&#x2192;4)-&#x3b2;-D-Glcp-(1&#x2192;), and conjugates thereof, to induce serum antibodies having bactericidal (killing) activity against hemolytic-uremic syndrome (HUS) causing, in particularO157. The conjugates, and compositions thereof, are useful as vaccines to induce serum antibodies which have bactericidal or bacteriostatic activity against, in particularO157, and are useful to prevent and/or treat illnesses caused byO157. The invention further relates to the antibodies which immunoreact with the O-specific polysaccharide ofO157 and/or the carrier, that are induced by these conjugates and/or compositions thereof. The invention also relates to methods and kits using one or more of the polysaccharides, conjugates or antibodies described above.

This invention relates to conjugates of the O-specific polysaccharide ofO157 with a carrier, and compositions thereof, and to methods of using of these conjugates and/or compositions thereof for eliciting an immunogenic response in mammals, including responses which provide protection against, or reduce the severity of, bacterial infections. More particularly it relates to the use of polysaccharides containing the tetrasaccharide repeat unit: (&#x2192;3)-&#x3b1;-D-GalpNAc-(1&#x2192;2)-&#x3b1;-D-PerpNAc-(1&#x2192;3)-&#x3b1;-L-Fucp-(1&#x2192;4)-&#x3b2;-D-Glcp-(1&#x2192;), and conjugates thereof, to induce serum antibodies having bactericidal (killing) activity against hemolytic-uremic syndrome (HUS) causingin particularO157. The conjugates, and compositions thereof, are useful as vaccines to induce serum antibodies which have bactericidal or bacteriostatic activity against againstin particularO157, and are useful to prevent and/or treat illnesses caused byO157. The invention further relates to the antibodies which immunoreact with the O-specific polysaccharide ofO157 and/or the carrier, that are induced by these conjugates and/or compositions thereof. The invention also relates to methods and kits using one or more of the polysaccharides, conjugates or antibodies described above.

Vaccines against Escherichia coli O157 infection

This invention relates to conjugates of the Vi polysaccharide of with the carrier recombinant exoprotein A (rEPA), and compositions thereof, and to methods of using of these conjugates and/or compositions thereof for eliciting an immunogenic response in humans, including responses which provide protection against, or reduce the severity of, bacterial infections. The conjugates, and compositions thereof, are useful as vaccines to induce serum antibodies againt and are useful to prevent and/or treat illnesses caused by

Method of immunizing humans against Salmonella typhi using a Vi-rEPA conjugate vaccine

The present invention is a modified plant, fruit or synthetic oligo- or polysaccharide which has been structurally altered so as to render the modified saccharide antigenically similar to the Vi of Salmonella typhi. The modified saccharide may be conjugated to a carrier to form a conjugate that is immunogenic against S. typhi. Antibodies produced in response to the immunogenic conjugate are protective against typhoid fever. Methods are provided for making the modified saccharide and the immunogenic conjugate.

Synthesis of typhoid fever vaccine from a plant or fruit polysaccharide

Vi capsular polysaccharides conjugated to toxin-dependent proteins can be used to enhance antibody response and to convert T-dependent properties to the Vi capsular polysaccharide. A heterobifunctional crosslinking agent can be used to bind thiol derivatives of the Vi capsular polysaccharides to the proteins, such as diphtheria, tetanus toxoids, cholera toxin and Haemophilus influenzae.

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Bethesda, MD, United States of America

Shousun Chen Szu