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首页> 外文期刊>Clinical and vaccine immunology: CVI >Phase I Safety and Immunogenicity Study of a Candidate Meningococcal Disease Vaccine Based on Neisseria lactamica Outer Membrane Vesicles
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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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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常见的 Neisseria 物种，包括 Neseria lactamica 的运输有关。我们以前已经证明了 N的外膜囊泡（OMV）。 lactamica 在脑膜炎球菌败血症小鼠模型中提供了针对致命性攻击的保护作用。我们评估了 N的安全性和免疫原性。一期安慰剂对照，双盲临床试验中使用了乳酸菌 OMV疫苗。 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注射后六个月也接受了第四次OMV疫苗。在接受OMV的组中，注射部位反应更为频繁，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，这是通过酶联免疫吸附测定确定的。此外，该疫苗还对六种不同的B型脑膜炎奈瑟氏球菌血清菌株产生适度的交叉反应免疫力，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倍的受试者百分比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疫苗报道的百分比相似。总之，这是 N。内酰胺 OMV疫苗是安全的，可诱导对 N的弱但广泛的体液免疫反应。脑膜炎。

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