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

Delia M Ramirez

John B Robbins

Stephen H Leppla

Rachel Schneerson

Joseph Shiloach

Mary Jo Rosovitz

S Dana Hsu

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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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.

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Bethesda, MD, United States of America

Delia M Ramirez