Schneemann Anette, Manchester Marianne
Department of Molecular Biology, The Scripps Research Institute, La Jolla, CA 92037, USA.
Future Microbiol. 2009 Feb;4(1):35-43. doi: 10.2217/17460913.4.1.35.
The CDC recommend 60 days of oral antibiotics combined with a three-dose series of the anthrax vaccine for prophylaxis after potential exposure to aerosolized Bacillus anthracis spores. The anthrax vaccine is currently not licensed for anthrax postexposure prophylaxis and has to be made available under an Investigational New Drug protocol. Postexposure prophylaxis based on antibiotics can be problematic in cases where the use of antibiotics is contraindicated. Furthermore, there is a concern that an exposure could involve antibiotic-resistant strains of B. anthracis. Availability of alternate treatment modalities that are effective in prophylaxis of inhalation anthrax is therefore highly desirable. A major research focus toward this end has been on passive immunization using polyclonal and monoclonal antibodies against B. anthracis toxin components. Since 2001, significant progress has been made in isolation and commercial development of monoclonal and polyclonal antibodies that function as potent neutralizers of anthrax lethal toxin in both a prophylactic and therapeutic setting. Several new products have completed Phase I clinical trials and are slated for addition to the National Strategic Stockpile. These rapid advances were possible because of major funding made available by the US government through programs such as Bioshield and the Biomedical Advanced Research and Development Authority. Continued government funding is critical to support the development of a robust biodefense industry.
美国疾病控制与预防中心建议，在可能接触雾化的炭疽芽孢杆菌孢子后，采用60天口服抗生素并结合三剂次炭疽疫苗进行预防。炭疽疫苗目前未被批准用于炭疽暴露后预防，必须根据新药临床试验申请方案提供。在抗生素使用禁忌的情况下，基于抗生素的暴露后预防可能会出现问题。此外，人们担心暴露可能涉及对炭疽杆菌的耐药菌株。因此，非常需要有可有效预防吸入性炭疽的替代治疗方法。为此，一个主要的研究重点是使用针对炭疽杆菌毒素成分的多克隆和单克隆抗体进行被动免疫。自2001年以来，在单克隆和多克隆抗体的分离及商业开发方面取得了重大进展，这些抗体在预防和治疗环境中均作为炭疽致死毒素的有效中和剂发挥作用。几种新产品已完成I期临床试验，并计划纳入国家战略储备。由于美国政府通过生物盾牌计划和生物医学高级研究与发展管理局等项目提供了大量资金，才得以取得这些快速进展。政府持续提供资金对于支持强大的生物防御产业发展至关重要。
