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首页> 外文期刊>Vaccine >Preclinical safety and immunogenicity evaluation of a nonavalent PorA native outer membrane vesicle vaccine against serogroup B meningococcal disease.
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Preclinical safety and immunogenicity evaluation of a nonavalent PorA native outer membrane vesicle vaccine against serogroup B meningococcal disease.

机译：针对血清B组脑膜炎球菌疾病的非价PorA天然外膜囊泡疫苗的临床前安全性和免疫原性评估。

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Background: An improved nonavalent PorA native outer membrane vesicle vaccine was developed with intrinsic adjuvating activity due to presence of less-toxic (lpxL1) LPS. In the present study, the safety and immunogenicity of this next-generation NonaMen vaccine were evaluated following repeated vaccination in rabbits and mice. Methods: A repeated-dose toxicology study was performed in rabbits. Immunogenicity of next-generation NonaMen was evaluated by determining the serum bactericidal antibody (SBA) titers against meningococcal serogroup B strains containing several PorA subtypes. Release of the pro-inflammatory cytokine, interleukin-6 (IL-6), by the human monocytic cell line (MM6) was measured to estimate pyrogenic activity. Results: No toxicologically relevant findings were noted in vaccinated rabbits receiving plain next-generation NonaMen. In agreement, next-generation NonaMen induced reduced amounts of the pro-inflammatory cytokine, IL-6, released by human monocyte cell line. In both rabbits and mice, next-generation NonaMen induced high SBA titers against all tested MenB strains regardless of whether or not aluminium phosphate adjuvant is used. Conclusions: The data suggest that next-generation NonaMen is a safe vaccine with the potential to develop a broadly protective immune response and encourage the start of the first clinical studies.
机译：背景：由于存在毒性较小的（lpxL1）LPS，开发了一种具有内在辅助活性的改良的非价PorA天然外膜囊泡疫苗。在本研究中，在兔子和小鼠中反复接种疫苗后，评估了这种下一代NonaMen疫苗的安全性和免疫原性。方法：对家兔进行了重复剂量毒理学研究。通过确定抗脑膜炎双球菌血清B群菌株的血清杀菌抗体（SBA）滴度来评估下一代NonaMen的免疫原性。测量人单核细胞系（MM6）促炎细胞因子白介素6（IL-6）的释放，以估算热原活性。结果：在接受普通的下一代NonaMen疫苗接种的兔子中，没有发现与毒理学相关的发现。一致的是，下一代NonaMen诱导了人类单核细胞系释放的促炎细胞因子IL-6减少。在兔子和小鼠中，无论是否使用磷酸铝佐剂，新一代的NonaMen均可针对所有测试的MenB菌株诱导较高的SBA效价。结论：数据表明，下一代NonaMen是一种安全的疫苗，具有产生广泛保护性免疫反应的潜力，并鼓励开展第一项临床研究。

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