RBCG30

rBCG30 is a prospective Bacillus Calmette-Guérin vaccine against tuberculosis. It is a live vaccine, consisting of BCG, which has been evaluated as a tuberculosis vaccination. It is genetically modified to produce abundant amounts of mycolyl transferase, a 30kDa antigen that has been shown to produce a strong immune response in animals and humans. rBCG30 had been in human clinical trials, but no clinical development has been reported since 2007.

History

Trials with rBCG30 were halted as the vaccine contained an antibiotic resistance gene. A new version of the vaccine without the antibiotic resistance marker was created. This new version of the vaccine, rBCG30-ARMF-II, often called rBCG30, also expresses 2.6 fold more Ag85B than the original vaccine.

Research

The vaccine completed a Phase I double-blind randomized controlled clinical trial that demonstrated that rBCG30 was safe and immunogenic; during nine months of follow-up, rBCG30, but not BCG, induced significantly increased Antigen 85B-specific immune responses in eight immunological assays. An additional animal study found that rBCG30 also helps protect against Mycobacterium leprae, the bacteria that causes leprosy. Disrupting IL10/STAT3 signaling during vaccination through small molecules enhances vaccination efficacy.