Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Helwan University, Cairo, Egypt.
Pharm Dev Technol. 2013 Sep-Oct;18(5):1175-85. doi: 10.3109/10837450.2011.618949. Epub 2011 Oct 10.
There is a need to use the new technologies to induce immunity with minimum number of vaccination sessions to ensure compliance with reducing cost.
To develop single shot vaccines of tetanus, diphtheria and divalent toxoids microsphere's formulations and to induce their immune response after intranasal and subcutaneous administration in mice.
The microspheres were prepared using different concentrations of chitosan. Microsphere's morphology, particle size analysis, encapsulation efficiency and antigen integrity were performed and the best formulations were selected for in vitro and in vivo testing in mice.
The developed microspheres have a yield percent of 70.3-91.5%. In vitro release of antigens indicated that tetanus release was increased up to 75 and 81% post T5 and TD5 formulations respectively, whereas diphtheria cumulative release increased up to 74 and 69% post D3 and TD5, respectively.
Antibody levels produced were lower than that obtained from alum adsorbed vaccine but higher than the minimum level required to induce immunogenicity (>0.01 IU/mL). The subcutaneous route of administration was superior over the intranasal route in producing higher antibody levels.
Chitosan microspheres were developed successfully and prove that chitosan represents a good candidate for vaccines delivery.
需要利用新技术，通过最少的接种次数诱导免疫，以确保降低成本的同时符合规定。
开发破伤风、白喉和双价类毒素微球的单针疫苗制剂，并在小鼠中经鼻内和皮下给药后诱导其免疫应答。
使用不同浓度的壳聚糖制备微球。对微球的形态、粒径分析、包封效率和抗原完整性进行了研究，并选择最佳配方进行了小鼠体内和体外试验。
所开发的微球的产率为 70.3-91.5%。体外释放的抗原表明，T5 和 TD5 制剂的破伤风释放量分别增加了 75%和 81%，而 D3 和 TD5 制剂的白喉累积释放量分别增加了 74%和 69%。
产生的抗体水平低于铝佐剂吸附疫苗，但高于诱导免疫所需的最低水平（>0.01 IU/mL）。与鼻内途径相比，皮下途径更能产生更高水平的抗体。
壳聚糖微球的开发取得了成功，证明壳聚糖是疫苗输送的良好候选物。
