Savoji Mohammad Ali, Haghighat Setareh, Mirzaee Mina, Golkaran Bahareh, Mirzaee Rayhaneh, Esfandiari Behzad, Mahdavi Mehdi
Department of Microbiology, Faculty of Advanced Sciences & Technology, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.
Department of Epidemiology and Biostatistics, Pasteur Institute of Iran, Tehran, Iran.
Gastroenterol Hepatol Bed Bench. 2019 Fall;12(4):292-300.
In the present study, a new formulation of HBsAg vaccine was developed and compared with a commercial peer.
Vaccination of hepatitis B infection has been an unavoidable affair since the 1980s, though it has numerous limitations such as inefficacy in the induction of cellular immune responses. To address these limitations, research on novel formulations is necessary to develop a superior formulation with the potency of induction of both cellular and humoral immune responses.
HBsAg was formulated in oil-in-water adjuvant Montanide ISA-266 (5 µg/dose) using homogenizer. Balb/C mice were then immunized three times at days 0, 14, and 28 with HBsAg/Montanide ISA-266 or HBsAg/alum with proper control groups. Two weeks after the last immunization, immunological parameters including IL-2, IL-4, TNF-α, IFN-γ, total IgG and IgG1/IgG2a isotypes were assessed by ELISA.
The results demonstrated that the formulation of HBsAg with Montanide ISA-266 enhanced humoral immune responses versus the commercial vaccine and control groups. No significant difference in terms of Th1 pattern was found between HBsAg/Montanide ISA-266 and the commercial vaccine.
Formulation of HBsAg with an oil-based adjuvant may be useful for the induction of a more potent humoral immune response compared to the commercially available HBV vaccine.
在本研究中，研发了一种新型乙肝表面抗原（HBsAg）疫苗制剂，并与市售同类产品进行比较。
自20世纪80年代以来，乙肝感染疫苗接种一直是不可避免的事情，尽管它有许多局限性，如诱导细胞免疫反应无效。为了解决这些局限性，有必要开展新型制剂的研究，以开发出一种既能诱导细胞免疫反应又能诱导体液免疫反应的更优制剂。
使用匀浆器将HBsAg与水包油佐剂Montanide ISA - 266（5微克/剂量）混合制成制剂。然后在第0、14和28天用HBsAg/Montanide ISA - 266或HBsAg/明矾对Balb/C小鼠进行三次免疫，并设置适当的对照组。最后一次免疫后两周，通过酶联免疫吸附测定（ELISA）评估包括白细胞介素-2（IL - 2）、白细胞介素-4（IL - 4）、肿瘤坏死因子-α（TNF - α）、干扰素-γ（IFN - γ）、总免疫球蛋白G（IgG）以及IgG1/IgG2a亚型在内的免疫参数。
结果表明，与市售疫苗和对照组相比，HBsAg与Montanide ISA - 266混合制成的制剂增强了体液免疫反应。HBsAg/Montanide ISA - 266与市售疫苗在Th1模式方面未发现显著差异。
与市售乙肝疫苗相比，用油性佐剂配制HBsAg可能有助于诱导更强的体液免疫反应。
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