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 Department of Health

Joseph Shiloach

John B Robbins

Rachel Schneerson

Stephen H Leppla

Joanna Kubler-Kielb

Fathy Majadly

Darrell T Liu

Shousun Chen Szu

Zuzana Kossaczka

Mary Jo Rosovitz

S Dana Hsu

Delia M Ramirez

Ronald D Sekura

Yan-Ling Zhang

Methods for making an immunogenic conjugate that includes a hapten or an antigen covalently linked to a carrier. The methods include reacting a first agent with a dihydrazide resulting in a hydrazine-modified first agent, wherein the first agent is a hapten, an antigen or a carrier; reacting a second agent with a benzaldehyde compound resulting in a benzaldehyde-modified second agent, wherein the second agent is a hapten, an antigen or a carrier, provided that the first agent or the second agent is a carrier; and reacting the hydrazine-modified first agent with the benzaldehyde-modified second agent resulting in an immunogenic conjugate comprising a hapten or an antigen covalently linked to a carrier via a hydrazone linkage.

Methods for preparing immunogenic conjugates

The invention relates to improved methods of producing and recovering sporulation-deficientmutant stains, and for producing and recovering recombinantprotective antigen (PA), especially modified PA which is protease resistant, and to methods of using of these PAs or nucleic acids encoding these PAs for eliciting an immunogenic response in humans, including responses which provide protection against, or reduce the severity of,bacterial infections and which are useful to prevent and/or treat illnesses caused by, such as inhalation anthrax, cutaneous anthrax and gastrointestinal anthrax.

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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

Immunogenic compositions and methods for eliciting an immune response againstand other bacilli are provided that include immunogenic conjugates of a poly-&#x3b3;-glutamic acid (&#x3b3;PGA) polypeptide of, or of anotherthat expresses a &#x3b3;PGA polypeptide. The &#x3b3;PGA conjugates elicit an effective immune response against, or against another, in mammalian hosts to which the conjugates are administered.

Poly-gamma-glutamic conjugates for eliciting immune responses directed against bacilli

The invention relates to improved methods of producing and recoveringprotective antigen (PA), especially modified PA which is protease resistant, and to methods of using of these PAs or nucleic acids encoding these PAs for eliciting an immunogenic response in humans, including responses which provide protection against, or reduce the severity of,bacterial infections and which are useful to prevent and/or treat illnesses caused by, such as inhalation anthrax, cutaneous anthrax and gastrointestinal anthrax.

Methods for making an immunogenic conjugate that includes a hapten or an antigen covalently linked to a carrier. The methods include reacting a first agent with a dihydrazide resulting in a hydrazino-modified first agent, wherein the first agent is a hapten, an antigen or a carrier; reacting a second agent with a benzaldehyde compound resulting in a benzaldehyde-modified second agent, wherein the second agent is a hapten, an antigen or a carrier, provided that the first agent or the second agent is a carrier; and reacting the hydrazine-modified first agent with the benzaldehyde-modified second agent resulting in an immunogenic conjugate comprising a hapten or an antigen covalently linked to a carrier via a hydrazone linkage.

A fermentation level cultivation of Bordetella pertussis bacteria on commercial scale is described. The critical factors in large scale cultivation of the bacteria are the presence of an antifoam agent and maintaining proper oxygen level and iron content in the culture medium. Pertussis toxin produced by the bacteria parallels the rate of growth of the bacteria.

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Rockville, MD, United States of America

Joseph Shiloach