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Biosafety aspects of the recombinant live oral Vibrio cholerae vaccine strain CVD 103-HgR

机译：口服重组霍乱弧菌活疫苗CVD 103-HgR的生物安全性

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The development of live attenuated vaccines, allowing for the safe and effective immunisation at mucosal surfaces, is a strategy of great interest for vaccinologists. The main advantage of this approach over conventional parenteral vaccines is the induction of strong mucosal immune responses, allowing targeting of the pathogen at the initial point of contact with the host. Further advantages include the ease of administration, high acceptance by vaccines, and relatively low production costs. Finally, well-characterised, safe and immunogenic vaccine strains are well suited as vectors for the mucosal delivery of foreign vaccine antigens and of DNA vaccines. However, such vaccines, when based on or containing genetically modified organisms (GMOs), are facing new and specific regulatory hurdles, particularly regarding the potential risks for humans and the environment. In this contribution we address selected aspects of the risk assessment of live attenuated bacterial vaccines covered in the course of the registration of vaccine strain CVD 103-HgR as a recombinant live oral vaccine against cholera.
机译：减毒活疫苗的开发，允许在粘膜表面进行安全有效的免疫接种，是疫苗学家非常感兴趣的策略。与常规的肠胃外疫苗相比，该方法的主要优点是可诱导强烈的粘膜免疫反应，从而可在与宿主接触的最初阶段将病原体靶向。进一步的优势包括易于管理，被疫苗高度接受以及相对较低的生产成本。最后，特征明确，安全且具有免疫原性的疫苗株非常适合作为粘膜递送外来疫苗抗原和DNA疫苗的载体。然而，当这种疫苗基于或包含转基因生物时，正面临着新的和具体的监管障碍，尤其是在对人类和环境的潜在风险方面。在这项贡献中，我们解决了减毒活细菌疫苗的风险评估的某些方面，该减毒细菌疫苗在疫苗株CVD 103-HgR注册为针对霍乱的重组活口服疫苗的过程中涉及。

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