School of Dental Medicine, University of Pennsylvania, Philadelphia, PA, 19104, USA.
School of Dental Medicine, University of Pennsylvania, Philadelphia, PA, 19104, USA.
Biomaterials. 2022 Sep;288:121671. doi: 10.1016/j.biomaterials.2022.121671. Epub 2022 Jul 18.
Because oral transmission of SARS-CoV-2 is 3-5 orders of magnitude higher than nasal transmission, we investigated debulking of oral viruses using viral trap proteins (CTB-ACE2, FRIL) expressed in plant cells, delivered through the chewing gum. In omicron nasopharyngeal (NP) samples, the microbubble count (based on N-antigen) was significantly reduced by 20 μg of FRIL (p < 0.0001) and 0.925 μg of CTB-ACE2 (p = 0.0001). Among 20 delta or omicron NP samples, 17 had virus load reduced below the detection level of spike protein in the RAPID assay, after incubation with the CTB-ACE2 gum powder. A dose-dependent 50% plaque reduction with 50-100 ng FRIL or 600-800 μg FRIL gum against Influenza strains H1N1, H3N2, and Coronavirus HCoV-OC43 was observed with both purified FRIL, lablab bean powder or gum. In electron micrographs, large/densely packed clumps of overlapping influenza particles and FRIL protein were observed. Chewing simulator studies revealed that CTB-ACE2 release was time/dose-dependent and release was linear up to 20 min chewing. Phase I/II placebo-controlled, double-blinded clinical trial (IND 154897) is in progress to evaluate viral load in saliva before or after chewing CTB-ACE2/placebo gum. Collectively, this study advances the concept of chewing gum to deliver proteins to debulk oral viruses and decrease infection/transmission.
由于 SARS-CoV-2 的经口传播比经鼻传播高出 3-5 个数量级,因此我们研究了使用在植物细胞中表达的病毒陷阱蛋白(CTB-ACE2、FRIL)来减少口腔病毒,这些蛋白通过咀嚼胶递送至体内。在奥密克戎鼻咽(NP)样本中,FRIL(p<0.0001)和 CTB-ACE2(p=0.0001)的用量为 20μg 时,微泡计数(基于 N 抗原)显著降低。在 20 个 delta 或奥密克戎 NP 样本中,在与 CTB-ACE2 口香糖粉末孵育后,17 个样本的病毒载量降低到 RAPID 检测方法中 Spike 蛋白的检测水平以下。用纯化的 FRIL、菜豆粉或口香糖观察到 FRIL 对甲型流感 H1N1、H3N2 和冠状病毒 HCoV-OC43 菌株的 50%噬菌斑减少具有剂量依赖性,50-100ng FRIL 或 600-800μg FRIL 胶用量均可达到。在电子显微镜照片中,观察到大量密集的重叠流感颗粒和 FRIL 蛋白团块。咀嚼模拟器研究表明,CTB-ACE2 的释放量与时间/剂量呈依赖性,在咀嚼 20 分钟内释放量呈线性增加。正在进行 I/II 期安慰剂对照、双盲临床试验(IND 154897),以评估咀嚼 CTB-ACE2/安慰剂口香糖前后唾液中的病毒载量。总的来说,这项研究推进了使用咀嚼胶递送至口腔病毒并减少感染/传播的概念。