New vaccines against tuberculosis.

The only currently licensed tuberculosis (TB) vaccine, bacille Calmette Guérin, confers incomplete protection against tuberculosis, and is not safe in infants infected with the human immunodeficiency virus. A new, safe vaccine regimen, which better protects against lung disease, is urgently needed to control TB in high-burden countries. Multiple candidate vaccines have shown promise in preclinical studies, and are now entering phase 1 to 2B clinical trials. This article discusses progress in the field and issues surrounding safety, reactogenicity, immunogenicity, and efficacy testing of new TB vaccines.