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Phase I Safety and Immunogenicity Study of a Candidate Meningococcal Disease Vaccine Based on Neisseria lactamica Outer Membrane Vesicles▿

机译:基于乳酸奈瑟氏菌外膜囊泡的候选脑膜炎球菌疾病疫苗的I期安全性和免疫原性研究▿

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摘要

Natural immunity to meningococcal disease in young children is associated epidemiologically with carriage of commensal Neisseria species, including Neisseria lactamica. We have previously demonstrated that outer membrane vesicles (OMVs) from N. lactamica provide protection against lethal challenge in a mouse model of meningococcal septicemia. We evaluated the safety and immunogenicity of an N. lactamica OMV vaccine in a phase I placebo-controlled, double-blinded clinical trial. Ninety-seven healthy young adult male volunteers were randomized to receive three doses of either an OMV vaccine or an Alhydrogel control. Subsequently, some subjects who had received the OMV vaccine also received a fourth dose of OMV vaccine, 6 months after the third dose. Injection site reactions were more frequent in the OMV-receiving group, but all reactions were mild or moderate in intensity. The OMV vaccine was immunogenic, eliciting rises in titers of immunoglobulin G (IgG) against the vaccine OMVs, together with a significant booster response, as determined by an enzyme-linked immunosorbent assay. Additionally, the vaccine induced modest cross-reactive immunity to six diverse strains of serogroup B Neisseria meningitidis, including IgG against meningococcal OMVs, serum bactericidal antibodies, and opsonophagocytic activity. The percentages of subjects showing ≥4-fold rises in bactericidal antibody titer obtained were similar to those previously reported for the Norwegian meningococcal OMV vaccine against the same heterologous meningococcal strain panel. In conclusion, this N. lactamica OMV vaccine is safe and induces a weak but broad humoral immune response to N. meningitidis.
机译:在流行病学上,幼儿对脑膜炎球菌疾病的天然免疫力与携带共生的奈瑟氏球菌,包括乳酸奈瑟氏球菌有关。我们以前已经证明,来自乳杆菌的外膜囊泡(OMV)在脑膜炎球菌败血症的小鼠模型中提供了针对致命性攻击的保护作用。在一项I期安慰剂对照,双盲临床试验中,我们评估了乳酸奈瑟氏菌OMV疫苗的安全性和免疫原性。 97名健康的年轻成年男性志愿者被随机分配接受三剂OMV疫苗或Alhydrogel对照。随后,一些接受过OMV疫苗的受试者在第三次接种后六个月也接受了第四次OMV疫苗接种。在接受OMV的组中,注射部位的反应更为频繁,但所有反应的强度均为轻度或中度。 OMV疫苗具有免疫原性,可引起针对疫苗OMV的免疫球蛋白G(IgG)效价的升高,以及明显的加强免疫反应,如通过酶联免疫吸附测定所确定的。另外,该疫苗对六种不同的B群脑膜炎奈瑟氏球菌菌株产生适度的交叉反应免疫,包括针对脑膜炎球菌OMV的IgG,血清杀菌抗体和调理吞噬活性。显示获得的杀菌抗体效价提高≥4倍的受试者百分率与先前针对相同异源脑膜炎球菌菌株的挪威脑膜炎球菌OMV疫苗报告的百分数相似。总之,这种内酰胺乳杆菌OMV疫苗是安全的,可诱导针对脑膜炎奈瑟氏菌的微弱但广泛的体液免疫反应。

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