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≥56 岁成年人初次接种四价脑膜炎球菌结合疫苗(MenACYW-TT)5 年后的免疫持久性和加强免疫应答。

Immune persistence and booster response of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) 5 years after primary vaccination of adults at ≥56 years of age.

机构信息

Global Medical Affairs, Sanofi, Swiftwater, PA, USA.

Jacksonville Center for Clinical Research, Jacksonville, FL, USA.

出版信息

Hum Vaccin Immunother. 2024 Dec 31;20(1):2426868. doi: 10.1080/21645515.2024.2426868. Epub 2024 Nov 18.

DOI:10.1080/21645515.2024.2426868
PMID:39555800
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11581192/
Abstract

Stage I of this study (NCT04142242) demonstrated the safety and immunogenicity of a booster dose of a licensed quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) and immune persistence 3 and 6-7 years after priming in older adults who received either quadrivalent meningococcal polysaccharide vaccine (MPSV4) or MenACYW-TT at ≥56 years of age. Stage II, reported here, assessed the antibody persistence after MenACYW-TT versus MPSV4 priming and the safety and immunogenicity of a booster dose of MenACYW-TT in older adults 5 years after primary vaccination with either MPSV4 or MenACYW-TT. A serum bactericidal assay (hSBA) was used to measure functional antibodies against each serogroup immediately before MenACYW-TT booster vaccination and on day (D) 30 post-booster. Safety was also assessed. Antibody persistence declined 5 years post-primary vaccination, with seroprotection (hSBA titer ≥1:8) rates trending higher in MenACYW-TT- versus MPSV4-primed participants. A robust immune response for all four serogroups was observed on D30 after the MenACYW-TT booster, with higher geometric mean titers and seroprotection rates in MenACYW-TT- versus MPSV4-primed participants. Safety outcomes were similar between the two groups. A single booster dose of MenACYW-TT was well tolerated and immunogenic in older adults, with a higher immune response observed in those primed with MenACYW-TT.

摘要

这项研究的第一阶段(NCT04142242)证明了在≥56 岁已接种四价脑膜炎球菌多糖疫苗(MPSV4)或脑膜炎球菌结合疫苗(MenACYW-TT)的老年人中,接种一剂许可的四价脑膜炎球菌结合破伤风类毒素疫苗(MenACYW-TT)加强针的安全性和免疫原性,以及在初次免疫后 3 年和 6-7 年内的免疫持久性。本报告介绍的第二阶段评估了 MenACYW-TT 与 MPSV4 作为初免后,老年人在初次接种 MPSV4 或 MenACYW-TT 后 5 年接种 MenACYW-TT 加强针的抗体持久性,以及安全性和免疫原性。使用血清杀菌试验(hSBA)来测量在 MenACYW-TT 加强针接种前和加强针接种后第 30 天(D)针对每个血清群的功能性抗体。还评估了安全性。初次接种后 5 年,抗体持久性下降,MenACYW-TT 初免者的血清保护率(hSBA 滴度≥1:8)趋势更高。MenACYW-TT 加强针后第 30 天,所有四个血清群均观察到强大的免疫应答,MenACYW-TT 初免者的几何平均滴度和血清保护率更高。两组之间的安全性结果相似。一剂 MenACYW-TT 加强针在老年人中耐受性良好且具有免疫原性,MenACYW-TT 初免者的免疫反应更高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a7e0/11581192/9750db5ad72a/KHVI_A_2426868_F0001_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a7e0/11581192/9750db5ad72a/KHVI_A_2426868_F0001_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a7e0/11581192/9750db5ad72a/KHVI_A_2426868_F0001_OC.jpg

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