BOX 8-1 Goals of Anthrax Vaccine Development

Product characteristics

  • Antigen: The vaccine antigen, which must be demonstrated to stimulate protective immunity, should consist of a purified protein, a mixture of defined and purified proteins, or a conjugate of a purified protein and the capsule.

  • Dose requirements: The vaccine should require only two or three injections to elicit high titers of antibodies against the antigen.

  • Immunogenicity: The vaccine should be sufficiently immunogenic to elicit protective antibodies within 30 days so that antibiotics given to exposed individuals could be safely discontinued at 30 days.

  • Stability: The potency of the vaccine should remain stable for a long period of time, allowing it to be stockpiled.

Product performance

  • Efficacy: The vaccine should be demonstrated to protect monkeys challenged by the aerosol route, with immunity retained for at least a year after the completion of immunization.

  • Local reactions: The vaccine should not cause severe local reactions. This is important not only for better tolerability but also because severe local reactions may create a perception that a vaccine is dangerous, even when the local effects are transient and self-limited.

  • Systemic reactions: The vaccine should not cause severe systemic adverse reactions, as is expected of all vaccines.

Manufacturing

  • Production process: The production process for the vaccine should be easily scaled up and should ensure maintenance of product consistency.

Recommendation: DoD should continue and further expedite its research efforts pertaining to anthrax disease, the B. anthracis organism, and vaccines against anthrax. Research related to anthrax should include, in particular, efforts such as the following:

  • DoD should pursue and encourage research to develop an anthrax vaccine product that can be produced more consistently and that is less reactogenic than AVA;

  • DoD should pursue and encourage research regarding the B. anthracis capsule;

  • DoD should pursue and encourage research on the mechanisms of action of the anthrax toxins; such research could lead to the development of small-molecule inhibitors;



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