Slepenkin Anatoli, Pal Sukumar, Rasley Amy, Coleman Matthew A, de la Maza Luis M
Department of Pathology and Laboratory Medicine, Medical Sciences I, Room D440, University of California, Irvine, Irvine, CA, 92697-4800, USA.
Physical and Life Sciences Directorate, Lawrence Livermore National Laboratory, Livermore, CA, 94550-9234, USA.
NPJ Vaccines. 2024 Jun 10;9(1):104. doi: 10.1038/s41541-024-00880-6.
It is recommended that the adjuvant Montanide ISA 720 VG be used at a concentration of 70% v/v. At this concentration, Montanide causes at the site of immunization a local granuloma that can last for several weeks. To determine the safety and protective efficacy of a Chlamydia muridarum MOMP vaccine, formulated with CpG-1826 and four different concentrations of Montanide (70%, 50%, 30% and 10%), BALB/c (H-2) female mice were immunized twice intramuscularly. Local reactogenicity was significant for vaccines formulated with 70% or 50% Montanide but not for those inoculated with 30% or 10% Montanide. Robust humoral and cell mediated memory immune responses were elicited by the 70%, 50% and 30% Montanide formulations. Mice were challenged intranasally with 10 C. muridarum inclusion forming units (IFU). Based on changes in body weight, lungs's weight and number of IFU recovered, mice vaccinated with the 70%, 50% and 30% Montanide formulations were significantly protected, but not mice receiving 10% Montanide. To conclude, we recommend the 30% Montanide concentration to be tested in humans and animal models to determine its safety and efficacy, in comparison to the 70% Montanide concentration currently used. The 30% Montanide formulation could significantly facilitate licensing of this adjuvant for human use.
建议使用浓度为70%（体积/体积）的佐剂Montanide ISA 720 VG。在此浓度下，Montanide在免疫部位会引起持续数周的局部肉芽肿。为了确定用CpG-1826和四种不同浓度的Montanide（70%、50%、30%和10%）配制的鼠衣原体主要外膜蛋白（MOMP）疫苗的安全性和保护效力，对BALB/c（H-2）雌性小鼠进行了两次肌肉注射免疫。用70%或50% Montanide配制的疫苗局部反应原性显著，但用30%或10% Montanide接种的疫苗则不然。70%、50%和30% Montanide配方引发了强大的体液和细胞介导的记忆免疫反应。用10个鼠衣原体包涵体形成单位（IFU）对小鼠进行鼻内攻毒。根据体重变化、肺重量和回收的IFU数量，接种70%、50%和30% Montanide配方疫苗的小鼠得到了显著保护，但接种10% Montanide的小鼠没有。总之，我们建议在人类和动物模型中测试30% Montanide浓度，以确定其安全性和效力，并与目前使用的70% Montanide浓度进行比较。30% Montanide配方可显著促进该佐剂用于人类的许可。
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