Contributed by Marcus A. Horwitz, M.D., Department of Medicine, School of Medicine, University of California, Los Angeles
What is rBCG30?
rBCG30 is a live vaccine that is a recombinant form of BCG (Tice® strain). The vaccine has been genetically engineered to secrete large amounts of a protein of Mycobacterium tuberculosis, the primary causative agent of human tuberculosis. This protein, which has a mass of 30 kDa, is the most abundant protein secreted by M. tuberculosis, and it induces a strong immune response in animals and in humans. rBCG30 was developed at the University of California—Los Angeles by a team of investigators in the laboratory of Marcus A. Horwitz with funding from the U.S. National Institutes of Health. Other members of the development team included Günter Harth, Saša Masleša-Galić and Barbara Jane Dillon.
rBCG30 has been tested for efficacy in guinea pigs, a species that is highly susceptible to tuberculosis and in which the disease closely resembles the disease in humans. rBCG30 strongly protects guinea pigs from tuberculosis and protection is significantly greater than that afforded by BCG. In addition, rBCG30 has been tested for safety in animals, and it has been shown to be comparable in safety to BCG, a widely used vaccine with an excellent safety profile in humans.
rBCG30 has been manufactured by Good Manufacturing Practices (GMP) and the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) Application for its use in human studies. On February 17, 2004, the first volunteers were immunized with rBCG30 in a Phase 1 human study designed to assess the safety of the vaccine in healthy tuberculin-negative volunteers and the ability of the vaccine to induce an immune response to the 30 kDa protein. The Phase 1 study, sponsored by the Aeras Global Tuberculosis Vaccine Foundation, is being conducted under the direction of Dr. Daniel Hoft at St. Louis University.