Scientific Publications by FDA Staff

Expert Opin Biol Ther 2004 Sep;4(9):1493-504

Tuberculosis vaccine development: research, regulatory and clinical strategies.

Brennan MJ, Morris SL, Sizemore CF

Brennan MJ, US FDA, Ctr Biol Evaluat & Res, Lab Mycobacterial Dis & Cellular Immunol, Bldg 29,Rm 503,HFM-431,29 Lincoln Dr, Bethesda, MD 20892 USA US FDA, Ctr Biol Evaluat & Res, Lab Mycobacterial Dis & Cellular Immunol, Bethesda, MD 20892 USA NIAID, TB & Other Mycobacterial Dis Sect, Resp Dis Branch, Div Microbiol & Infect Dis,NIH, Bethesda, MD 20892 USA

In the past decade, while the global tuberculosis (TB) epidemic has continued to devastate mankind, considerable progress has nevertheless been made in the development of new and improved vaccines for this ancient disease. Recombinant bacillus Calmette-Guerin strains, DNA-based vaccines, live attenuated Mycobacterium tuberculosis vaccines and subunit vaccines formulated with novel adjuvants have shown promise in preclinical animal challenge models. Three of these vaccines are being evaluated at present in human clinical studies, and several other vaccine preparations are being targeted for clinical trials in the near future. Although the preclinical characterisation and testing of new TB vaccines has clearly led to exciting new findings, complex regulatory and clinical trial design issues remain as a challenge to TB vaccine development. This report reviews some of the exciting advances in TB research that have led to the development of new TB vaccines, and addresses the unique regulatory and clinical issues associated with the testing of novel anti-TB preparations in human populations.