Sanofi Pasteur, Swiftwater, PA, USA.
Heartland Research Associates, LLC, Wichita, KS, USA.
Vaccine. 2020 Jun 9;38(28):4405-4411. doi: 10.1016/j.vaccine.2020.04.067. Epub 2020 May 6.
Invasive meningococcal disease has a high mortality rate in individuals aged ≥56 years, but no vaccine is currently licensed in the USA for this age group. This study assessed the safety and immunogenicity of an investigational quadrivalent meningococcal tetanus toxoid conjugate vaccine (MenACYW-TT) compared with a meningococcal quadrivalent polysaccharide vaccine (MPSV4) in this age group.
This was a Phase III, modified double-blind, randomized, non-inferiority study (NCT02842866) across 35 clinical sites in the USA and Puerto Rico in individuals aged ≥56 years. A single dose of the MenACYW-TT (n = 451) or MPSV4 vaccine (n = 455) was administered on Day 0. A serum bactericidal assay with human (hSBA) and baby rabbit (rSBA) complement was used to measure antibodies against serogroups A, C, W, and Y test strains at baseline and Day 30. Safety data were collected up to six months post-vaccination.
The seroresponse to MenACYW-TT was non-inferior to MPSV4 for each of the serogroups (A: 58.2% vs. 42.5%; C: 77.1% vs. 49.7%; W: 62.6% vs. 44.8%, Y: 74.4% vs. 43.4%, respectively). At Day 30, participants achieving hSBA titers ≥1:8 were higher for all serogroups after MenACYW-TT vs. MPSV4 (77.4-91.7 vs. 63.1-84.2%, respectively). No safety concerns were identified for either vaccine.
MenACYW-TT was well-tolerated and immunogenic in ≥56-year-olds, offering the potential to replace MPSV4 in this age group.
侵袭性脑膜炎球菌病在 56 岁及以上人群中的死亡率很高，但目前美国还没有针对该年龄组的疫苗。本研究评估了一种研究性四价脑膜炎球菌破伤风类毒素结合疫苗（MenACYW-TT）与四价脑膜炎球菌多糖疫苗（MPSV4）在该年龄组中的安全性和免疫原性。
这是一项在美国和波多黎各的 35 个临床中心进行的 III 期、改良的双盲、随机、非劣效性研究（NCT02842866），纳入了 56 岁及以上的个体。在第 0 天，一组个体接受 MenACYW-TT（n=451）或 MPSV4 疫苗（n=455）单剂接种。使用人（hSBA）和幼兔（rSBA）补体血清杀菌试验来测量针对血清群 A、C、W 和 Y 测试菌株的抗体，基线和第 30 天。接种疫苗后六个月内收集安全性数据。
对于每个血清群，MenACYW-TT 的血清应答均不劣于 MPSV4（A：58.2% vs. 42.5%；C：77.1% vs. 49.7%；W：62.6% vs. 44.8%，Y：74.4% vs. 43.4%）。在第 30 天，MenACYW-TT 组的 hSBA 滴度≥1:8 的参与者比例高于 MPSV4 组（分别为 77.4-91.7% vs. 63.1-84.2%）。两种疫苗均未发现安全性问题。
MenACYW-TT 在 56 岁及以上人群中耐受性良好且具有免疫原性，有可能替代该年龄组中的 MPSV4。
