Technical Name Nanoemulsion adjuvant for nasal mucosa and preparation method thereof
Project Operator National Health Research Institutes
Summary
The soft and deformable behaviors dominate the monodisperse nanoemulsion can be controlled by the extruder membrane. With the aid of nanoemulsion, the antigen can be recognized by the mucosal immune system to generate broad-spectrum immune responses. This platform offers a better-adapted administration strategy comprising safety and efficacy.
Scientific Breakthrough
黏膜為多數病原感染時的主要標的。經黏膜進行免疫接種,對於誘發黏膜免疫以保護宿主,避免病原進入,為具可行性之策略。目前臨床上尚無核准之黏膜型佐劑,開發中之黏膜型佐劑多以黏膜刺激物或免疫調節劑為基礎,然而其安全性及免疫專一性仍有疑慮。國際NanoBio®公司所發展的NanoStat技術平台,雖然擁有奈米乳液之專利保護(US 8,771,731、US 8,877,208、US 8,962,026),但是該技術提升免疫效果的主要機制,在於使用離子型界面活性劑(cationic surfactant)以及添加免疫刺激物質,此外,所宣告的乳液粒徑大小為500 nm。在此之前,本研究團隊亦發現小鼠經鼻腔給予流感模擬疫苗,只有在添加次微米乳液搭配免疫刺激物質CpG或flagellin之複合佐劑,才能產生有效的保護效果。
此項專利技術的特點在於,可針對欲遞送物質及不同投予途徑,來挑選最適粒徑大小及組成之乳液作為傳遞系統;奈米級乳液之製備過程中,即使不使用離子型界面活性劑調配乳液、以及完全無添加其他免疫刺激物質,單純調整角鯊烯乳液之粒徑大小,次微米乳液與奈米級乳液所能幫助誘導的抗原專一性抗體效價,可達十倍之差別!此奈米級乳液作為疫苗遞送系統,經鼻腔黏膜投予可有效地誘發抗原專一性免疫反應,包括體液型免疫反應及細胞型免疫反應,若添加於癌症治療候選疫苗,可進一步抑制腫瘤的生長。動物實驗亦顯示奈米級乳液不會誘發IgE產生,證實其低致敏性。
1. Design and process different dimensions of the emulsions for optimization of vaccination routes, such as intramuscular, intranasal, oral or ocular vaccination.
2. Avoids damaging the vaccine antigens since the addition of antigens was carried out after high-shear emulsification process and free of organic solvents.
3. Intranasal vaccination with nanoemulsion-formulated antigen effectively elicited antigen-specific humoral and cellular immune responses.
4. Vaccination with nanoemulsion-formulated antigen would not result in the generation of IgE, indicating that this may not cause anaphylactoid reactions.
5. The use of the nanoemulsion as adjuvant for cancer immunotherapy would effectively inhibited tumor growth.
Industrial Applicability
1. A mucosal delivery system for drug/vaccine and nutrients; immunotherapy for cancer diseases, immunodeficiency, hypersensitivity; treatment for respiratory diseases. 
2. A platform technology to elucidate the relationship between the compositions (such as core oil and emulsifiers) of the emulsions and the elicited immune responses.
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