Novel GMO-Based Vaccines against Tuberculosis: State of the Art and Biosafety Considerations.
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.
Biosafety and Biotechnology Unit, Scientific Institute of Public Health, 14 Juliette Wytsman Street, Brussels 1050, Belgium. Amaya.Leunda@wiv-isp.be.
Amaya
A
Leunda
Biosafety and Biotechnology Unit, Scientific Institute of Public Health, 14 Juliette Wytsman Street, Brussels 1050, Belgium. Aline.Baldo@wiv-isp.be.
Aline
A
Baldo
Biosafety and Biotechnology Unit, Scientific Institute of Public Health, 14 Juliette Wytsman Street, Brussels 1050, Belgium. Martine.Goossens@wiv-isp.be.
Martine
M
Goossens
Immunology Unit, Scientific Institute of Public Health, 642 Engeland Street, Brussels 1180, Belgium. Kris.Huygen@wiv-isp.be.
Kris
K
Huygen
Biosafety and Biotechnology Unit, Scientific Institute of Public Health, 14 Juliette Wytsman Street, Brussels 1050, Belgium. Philippe.Herman@wiv-isp.be.
Philippe
P
Herman
Immunology Unit, Scientific Institute of Public Health, 642 Engeland Street, Brussels 1180, Belgium. Marta.Romano@wiv-isp.be.
Marta
M
Romano
biosafety; clinical trial; genetically modified organism; risk assessment; tuberculosis; vaccine candidate