Edible adjuvant expressed in transgenic soybeans

描述（由申请人提供）：在开发用于人类的新疫苗配方时面临的最重要的限制之一是缺乏安全、有效的佐剂，可以与有希望的新候选疫苗结合以刺激保护性宿主反应，在缺乏安全、有效的佐剂可以与这些新候选疫苗结合的情况下，疫苗本身通常不足以保护个体免受特定微生物疾病的侵害。对于亚单位疫苗的开发尤其如此，亚单位疫苗使用从微生物病原体中分离出的单一蛋白质，试图保护个体免受病毒、细菌或真菌病原体的侵害。这些亚单位疫苗通常非常安全，因为它们不会引起任何感染，而且与疫苗配方中有时使用的减毒或灭活微生物相比，它们的副作用更少。然而，使用这些更安全的亚单位疫苗有一个重大限制。微生物蛋白本身在刺激人体免疫反应方面通常做得很差，除非使用含有强佐剂的疫苗配方，特别是当试图刺激保护性的粘膜反应时。

DESCRIPTION (provided by applicant): One of the most significant limitations faced when developing new vaccine formulations for human use is the lack of safe, efficacious adjuvants that can be combined with promising new vaccine candidates to stimulate a protective host response, in the absence of safe, efficacious adjuvants that can be combined with these new vaccine candidates, the vaccine, by itself, is often not sufficient to protect individuals from a particular microbial disease. This is especially true for the development of subunit vaccines that use a single protein isolated from a microbial pathogen in an attempt to protect individuals from viral, bacterial, or fungal pathogens. These subunit vaccines are often very safe since they do not cause any infection and since they have fewer side effects than attenuated or killed microbes sometimes used in vaccine formulations. However there is one significant limitation in using these safer subunit vaccines. By themselves, the microbial proteins often do a poor job at stimulating human immune responses unless a vaccine formulation containing a strong adjuvant is used, especially when trying to stimulate a protective, mucosal response. In this grant application, Drs. Bost, Piller and Clemente propose to demonstrate the feasibility of developing an edible adjuvant expressed in transgenic plants. These novel studies focus on the use of a known adjuvant, the E. coil heat labile toxin (LT), and its expression in soybeans. A non-toxic form of this bacterial protein, which has potent adjuvant activity, will be expressed in soybeans, and its ability to function as an adjuvant following oral consumption will be demonstrated using a mouse immunization model. If successful, this work will provide an efficient expression system for production of large quantities of an edible adjuvant which is cost-effective to produce, safe to administer, and could be shipped worldwide in a highly stable form (i.e. soybeans). The fact that extensive procedures for processing soybeans into human consumables already exist suggest that this work could be readily translated to the production of a plant derived, edible adjuvant useful in novel human vaccine formulations.