Yoonjin Kim, Sungyeun Bae, Kyung-Sang Yu, SeungHwan Lee, Chankyu Lee, Jinil Kim, Howard Her, Jaeseong Oh
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引用次数: 0
摘要
我们在健康的韩国成年人中开展了一项随机、主动对照、双盲、首例人体 1 期研究,以评估针对 A、C、W、X 和 Y 血清群的新型五价脑膜炎球菌疫苗 EuNmCV-5 的安全性、耐受性和免疫原性。60 名参与者随机接种一剂 EuNmCV-5 或 MenACWY-CRM(含 A、C、W 和 Y 血清群的四价疫苗)。安全性通过监测过敏反应、28 天的不良反应和 180 天的严重不良反应进行评估。免疫原性通过兔补体依赖性血清杀菌抗体(rSBA)测定进行评估。EuNmCV-5 安全、耐受性良好,并能显著提高抗体滴度。对所有目标血清群的血清保护率超过 96.7%,血清转换率超过 85%。与 MenACWY-CRM.ClinicalTrials.gov identifier.NCT05739292 相比,它对血清 A 群和 C 群的血清转换率更高(p = 0.0016 和 0.0237,分别为 0.0016 和 0.0237),对所有目标血清群的 GMT 抗体滴度也大幅提高:NCT05739292。
A randomized study to evaluate the safety and immunogenicity of a pentavalent meningococcal vaccine.
A randomized, active-controlled, double-blind, first-in-human, phase 1 study was conducted in healthy Korean adults to evaluate the safety, tolerability, and immunogenicity of EuNmCV-5, a new pentavalent meningococcal vaccine targeting serogroups A, C, W, X, and Y. Sixty participants randomly received a single dose of either EuNmCV-5 or MenACWY-CRM, a quadrivalent vaccine containing serogroups A, C, W, and Y. Safety was assessed through monitoring anaphylactic reactions, adverse events for 28 days, and serious adverse events over 180 days. Immunogenicity was assessed via rabbit complement-dependent serum bactericidal antibody (rSBA) assay. EuNmCV-5 was safe, well-tolerated, and elicited a substantial antibody titer increase. The seroprotection rates exceeded 96.7%, and the seroconversion rates were over 85% for all the targeted serogroups. It showed higher seroconversion rates against serogroups A and C (p = 0.0016 and 0.0237, respectively) and elicited a substantial increase in GMT for all targeted serogroups compared to the MenACWY-CRM.ClinicalTrials.gov identifier: NCT05739292.
NPJ VaccinesImmunology and Microbiology-Immunology
CiteScore
11.90
自引率
4.30%
发文量
146
审稿时长
11 weeks
期刊介绍:
Online-only and open access, npj Vaccines is dedicated to highlighting the most important scientific advances in vaccine research and development.