Leunda Amaya, Baldo Aline, Goossens Martine, Huygen Kris, Herman Philippe, Romano Marta
Biosafety and Biotechnology Unit, Scientific Institute of Public Health, 14 Juliette Wytsman Street, Brussels 1050, Belgium.
Immunology Unit, Scientific Institute of Public Health, 642 Engeland Street, Brussels 1180, Belgium.
Vaccines (Basel). 2014 Jun 16;2(2):463-99. doi: 10.3390/vaccines2020463.
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.
需要新型高效疫苗来控制结核病（TB），结核病是全球发病和死亡的主要原因。目前有几种结核病候选疫苗正处于临床和临床前开发阶段。它们分为两类，一类是设计用于替代卡介苗（BCG）并接种给婴儿的候选疫苗，另一类是设计用作加强疫苗的亚单位疫苗。后者被设计为将接种给已接种卡介苗（或未来接种卡介苗替代疫苗）的个体的疫苗。在本综述中，我们提供了有关正在开发的新型结核病（TB）疫苗的最新信息，重点关注目前正在临床试验中评估的由转基因生物（GMO）组成的候选疫苗的风险评估。事实上，给志愿者接种这些疫苗会引发有关人类健康和环境的生物安全问题，需要进行评估和管理。
