Humoral response and genetic stability of recombinant BCG expressing hepatitis B surface antigens

The Bacille Calmette Guerin (BCG), long valued for its role as a live vaccine for the prevention of tuberculosis, is being used as a recombinant delivery vehicle for foreign antigens, principally, for inducing long-lived specific humoral and cellular immunity. Hepatitis B and its sequelae are major public health problems. Although vaccines have been available for over 20 years the disease remains a significant global problem. Many factors contribute to vaccine failure to control hepatitis B, including attaining of adequate immune protection. In this study, a novel rBCG delivery system is described using non-integrative plasmids harboring hepatitis B surface antigen genes. This rBCG was able to elicit an anti-HBs response in BALB/c mice. The titres of anti-HBs response obtained using rBCG was relatively lower than that of the commercial vaccine used as positive control. In vivo or in vitro stability assays showed that the vector used to generate rBCG is stable in spite of being a non-integrative plasmid. In addition, the HBsAg proteins expression profiles were almost similar to those obtained using an Escherichia coli expression system.