Department of Pharmaceutical Sciences, College of Pharmacy, Oregon State University, Corvallis, OR 97331, United States.
Int J Pharm. 2010 Jun 30;393(1-2):197-202. doi: 10.1016/j.ijpharm.2010.04.003. Epub 2010 Apr 21.
Nanoparticles are an attractive vaccine carrier with potent adjuvant activity. Data from our previous studies showed that immunization of mice with lecithin/glyceryl monostearate-based nanoparticles with protein antigens conjugated onto their surface induced a strong, quick, and long-lasting antigen-specific immune response. In the present study, we evaluated the feasibility of preserving the immunogenicity of protein antigens carried by nanoparticles without refrigeration using these antigen-conjugated nanoparticles as a model. The nanoparticles were lyophilized, and the immunogenicity of the antigens was evaluated in a mouse model using bovine serum albumin or the Bacillus anthracis protective antigen protein as model antigens. With proper excipients, the nanoparticles can be lyophilized while maintaining the immunogenicity of the antigens. Moreover, the immunogenicity of the model antigen conjugated onto the nanoparticles was undamaged after a relatively extended period of storage at room temperature or under accelerated conditions (37 degrees C) when the nanoparticles were lyophilized with 5% mannitol plus 1% polyvinylpyrrolidone. To our knowledge, the present study represents an early attempt to preserve the immunogenicity of the protein antigens carried by nanoparticles without refrigeration.
纳米颗粒是一种有吸引力的疫苗载体，具有很强的佐剂活性。我们之前的研究数据表明，用表面连接有蛋白抗原的卵磷脂/甘油单硬脂酸酯纳米颗粒免疫小鼠，可诱导强烈、快速和持久的抗原特异性免疫应答。在本研究中，我们评估了使用这些抗原偶联纳米颗粒作为模型，在不冷藏的情况下保持纳米颗粒携带的蛋白抗原免疫原性的可行性。将纳米颗粒冷冻干燥，并在小鼠模型中使用牛血清白蛋白或炭疽保护性抗原蛋白作为模型抗原来评估抗原的免疫原性。通过适当的赋形剂，纳米颗粒可以在冷冻干燥的同时保持抗原的免疫原性。此外，当纳米颗粒用 5%甘露醇加 1%聚乙烯吡咯烷酮冷冻干燥时，在室温或加速条件（37 摄氏度）下储存相对较长时间后，模型抗原在纳米颗粒上的免疫原性并未受损。据我们所知，本研究代表了早期尝试在不冷藏的情况下保持纳米颗粒携带的蛋白抗原免疫原性的努力。
