Novel GMO-Based Vaccines against Tuberculosis: State of the Art and Biosafety Considerations

Abstract

Novel efficient vaccines are needed to control tuberculosis (TB), a major cause of morbidity and mortality worldwide. Several TB vaccine candidates are currently in clinical and preclinical development. They fall into two categories, the one of candidates designed as a replacement of the Bacille Calmette Guérin (BCG) to be administered to infants and the one of sub-unit vaccines designed as booster vaccines. The latter are designed as vaccines that will be administered to individuals already vaccinated with BCG (or in the future with a BCG replacement vaccine). In this review we provide up to date information on novel tuberculosis (TB) vaccines in development focusing on the risk assessment of candidates composed of genetically modified organisms (GMO) which are currently evaluated in clinical trials. Indeed, these vaccines administered to volunteers raise biosafety concerns with respect to human health and the environment that need to be assessed and managed.

A HIV-Tat/C4-binding protein chimera encoded by a DNA vaccine is highly immunogenic and contains acute EcoHIV infection in mice

“…However, as the adjuvanticity of IMX313 requires efficient secretion of the oligomerised protein 14 , a TPA leader sequence was introduced upstream of the sequences encoding Tat and IMX313 to drive expression of the oligomerised protein into the secretory pathway. Indeed, DNA and recombinant viral vaccines encoding IMX313 are in advanced clinical testing 16 . DNA vaccines are stable, readily manufactured, induce humoral and CMI, and are licensed for veterinary use 17 , emphasising their potential in developing human vaccines.…”