Plans underway to launch U.S. study of tuberculosis vaccine.

2004 FEB 11 - (NewsRx.com & NewsRx.net) -- Corixa Corp. (CRXA), a developer of immunotherapeutics, and GlaxoSmithKline Biologicals (GSK Bio), a developer of vaccines and biologicals, announced that the U.S. Food and Drug Administration (FDA) is allowing the initiation of a phase I clinical study to evaluate the safety and immunogenicity of a novel, proprietary prophylactic vaccine designed to induce protection against tuberculosis (TB).

The trial will be conducted in the United States under the Investigational New Drug Application (IND), currently held by Corixa, and will be the first study of this TB vaccine to be conducted in human volunteers.

The vaccine combines a proprietary, recombinant tuberculosis protein antigen and a GSK Bio proprietary formulation that incorporates several adjuvants including Corixa's MPL adjuvant. MPL is Corixa's flagship adjuvant, which is present in multiple GSK Bio vaccines now in late-stage clinical development. The recombinant tuberculosis antigen is a fusion protein of antigenic domains taken from different Mycobacterium tuberculosis gene products that are recognized by immune system cells harvested from patients that had been infected with tuberculosis but who never showed signs of disease.

The fusion protein adjuvant combination appears to have demonstrated protection against tuberculosis infection in a number of relevant animal species including mice, guinea pigs and monkeys.

The vaccine is the first recombinant tuberculosis protein vaccine ...