RBCG30
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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.
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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 (blood lymphocyte proliferation, antibody responses by ELISA, interferon-gamma producing CD4+ and CD8+ T cells ex vivo, central memory CD4+ and CD8+ T cells, interferon-gamma ELISPOT responses, and the capacity of T cells to activate macrophages to inhibit mycobacterial intracellular multiplication). 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.