佐剂 GLA-AF 增强了人体皮内疫苗的应答反应。
The adjuvant GLA-AF enhances human intradermal vaccine responses.
机构信息
Infectious Diseases Research Institute, Seattle, WA 98102, USA.
PAI Life Sciences Inc., Seattle, WA 98102, USA.
出版信息
Sci Adv. 2018 Sep 12;4(9):eaas9930. doi: 10.1126/sciadv.aas9930. eCollection 2018 Sep.
Adjuvants are key to shaping the immune response to vaccination, but to date, no adjuvant suitable for human use has been developed for intradermal vaccines. These vaccines could be self-administered and sent through the mail as they do not require long needles or technical expertise in immunization. In the event of a pandemic outbreak, this approach could alleviate the congregation of patients in health centers and thus reduce the potential of these centers to enhance the spread of lethal infection. A reliable and potent vaccine system for self-administration would provide an effective countermeasure for delivery through existing product distribution infrastructure. We report results from preclinical and clinical trials that demonstrate the feasibility of an adjuvanted, intradermal vaccine that induced single shot protection in ferrets and seroprotection in humans against one of the more lethal strains of pandemic flu, Indonesia H5N1. In the human trial, the vaccine was safe and clinical responses were above approvable endpoints for a protective flu vaccine. Inclusion of a modern TLR4 (Toll-like receptor 4) agonist-based adjuvant was critical to the development of the response in the intradermal groups. In humans, this is the first report of a safe and effective intradermal adjuvant, GLA-AF (aqueous formulation of glucopyranosyl lipid adjuvant), and provides a future path for developing a vaccine-device combination for distribution by mail and self-administration in case of a pandemic.
佐剂是塑造疫苗免疫反应的关键,但迄今为止,尚未开发出适合人类使用的皮内疫苗佐剂。这些疫苗可以自我接种,并通过邮件发送,因为它们不需要长针或免疫接种方面的专业技术。在大流行爆发的情况下,这种方法可以减轻患者在医疗中心的聚集,从而降低这些中心增强致命感染传播的可能性。一种可靠且有效的自我接种疫苗系统将为通过现有产品分发基础设施提供有效的应对措施。我们报告了临床前和临床试验的结果,这些结果证明了一种佐剂皮内疫苗的可行性,该疫苗可诱导单次注射保护雪貂免受更致命的流感大流行株之一(印度尼西亚 H5N1)的侵害,并在人类中诱导血清保护。在人体试验中,该疫苗是安全的,临床反应高于保护性流感疫苗的批准终点。包含现代 TLR4(Toll 样受体 4)激动剂佐剂对于皮内组反应的发展至关重要。在人类中,这是首次报道安全有效的皮内佐剂 GLA-AF(葡糖苷脂质佐剂的水性制剂),并为开发在大流行情况下通过邮件发送和自我接种的疫苗设备组合提供了未来的途径。