Bo Cunpei, Wei Xiaoli, Wang Xue, Ji Wenheng, Yang Huan, Zhao Yuxiu, Wang Hui
Beijing Institute of Biological Products Company Limited, Beijing 100176, China.
Heliyon. 2023 Jul 28;9(8):e18800. doi: 10.1016/j.heliyon.2023.e18800. eCollection 2023 Aug.
Aluminum salts are by far the most widely used adjuvants for human vaccines, showing acceptable safety and efficacy. Previous studies have shown that each aluminum adjuvant have different charges and morphologies, but whether the manufacturing and production processes affects the physicochemical properties of aluminum adjuvant has not yet been reported. In this study, we explored the physical and chemical properties of different aluminum adjuvants and Hib, sIPV antigens through particle size, zeta potential and morphological characteristics. The adsorption rate and efficacy were also investigated. The results showed that the preparation process had an impact on the physical and chemical properties of aluminum adjuvants, including differences in the particle size，zeta potential and morphological structure. Hib vaccine had larger particle size than sIPV vaccine with different aluminum adjuvants in the process of vaccine preparation. In addition, by measuring the adsorption rate, increasing the concentration of phosphate or Aluminum phosphate (AP) can improve the adsorption rate of Hib, but Aluminium hydroxide (AH) and amorphous aluminum hydroxyphosphate sulfate (AAHS) adjuvants are not affected. result showed that increasing the adsorption rate of Hib could enhance the Hib-IgG antibody titers. In conclusion, this study provides a reference for the application of adjuvants in vaccines by studying the physicochemical properties and adsorption conditions of different aluminum adjuvants and antigens.
铝盐是目前人类疫苗中使用最广泛的佐剂，具有可接受的安全性和有效性。先前的研究表明，每种铝佐剂都有不同的电荷和形态，但制造和生产过程是否会影响铝佐剂的物理化学性质尚未见报道。在本研究中，我们通过粒径、zeta电位和形态特征探索了不同铝佐剂与Hib、sIPV抗原的物理化学性质。还研究了吸附率和效力。结果表明，制备过程对铝佐剂的物理化学性质有影响，包括粒径、zeta电位和形态结构的差异。在疫苗制备过程中，与不同铝佐剂结合的Hib疫苗比sIPV疫苗具有更大的粒径。此外，通过测量吸附率，增加磷酸盐或磷酸铝（AP）的浓度可以提高Hib的吸附率，但氢氧化铝（AH）和无定形羟基磷酸铝硫酸盐（AAHS）佐剂不受影响。结果表明，提高Hib的吸附率可以增强Hib-IgG抗体滴度。总之，本研究通过研究不同铝佐剂和抗原的物理化学性质及吸附条件，为佐剂在疫苗中的应用提供了参考。
