Centre for Vaccine Clinical Research, Center for Disease Prevention, 18 Jinzhou Street, 530022 Nanning City, China.
Immun Ageing. 2008 Feb 20;5:2. doi: 10.1186/1742-4933-5-2.
The safety and immunogenicity of an MF59-adjuvanted subunit influenza vaccine (Sub/MF59; FLUAD, Novartis Vaccines) was evaluated among elderly Chinese subjects (> or = 60 years of age). After a preliminary Phase I, open-label study (n = 25) to assess safety 1-14 days post-vaccination, a comparative observer-blind, randomised, controlled clinical trial (n = 600) was performed to assess safety and immunogenicity versus a non-adjuvanted subunit influenza vaccine (Subunit; Agrippal, Novartis Vaccines). Subjects were randomised (2:1) to receive Sub/MF59 or Subunit.
Both vaccines were well tolerated, with no vaccine-related serious adverse events reported during the Phase I trial. During the observer-blind study, local and systemic reactions were generally similar for both vaccines 1-22 days post-vaccination; however, injection-site induration was more frequent among the Subunit group (P < 0.05), and mild pain at the injection site and fever were more frequent among Sub/MF59 recipients (P < or = 0.005). Both vaccines induced a significant (P < 0.001) increase in geometric mean titres (GMTs) for the three strains tested, versus baseline; GMTs against A/H1N1, A/H3N2 and B were significantly higher in the Sub/MF59 group (P = 0.034, P < 0.001 and P = 0.005, respectively). GMT ratios against A/H1N1, A/H3N2 and B were also significantly higher in the Sub/MF59 group (P = 0.038, P < 0.001 and P = 0.006, respectively). Similarly, the percentage of subjects achieving seroprotection or seroconversion on Day 22 was greater for Sub/MF59 recipients, reaching significance for A/H3N2 (P < 0.001).
MF59-adjuvanted subunit influenza vaccine is well tolerated by elderly Chinese subjects and induces a higher level of immunogenicity than a non-adjuvanted subunit influenza vaccine in this population that is at high risk of influenza-related complications.
http://www.clinicaltrials.gov, NCT00310648.
在老年中国受试者（≥ 60 岁）中，评估了 MF59 佐剂亚单位流感疫苗（Sub/MF59；FLUAD，诺华疫苗）的安全性和免疫原性。在初步的 I 期、开放性研究（n = 25）评估接种后 1-14 天的安全性后，进行了一项比较观察者盲法、随机、对照临床试验（n = 600），以评估与非佐剂亚单位流感疫苗（Subunit；Agrippal，诺华疫苗）相比的安全性和免疫原性。受试者按照 2:1 的比例随机分配至 Sub/MF59 或 Subunit 组。
两种疫苗均具有良好的耐受性，在 I 期试验期间未报告与疫苗相关的严重不良事件。在观察者盲法研究中，接种后 1-22 天，两种疫苗的局部和全身反应通常相似；然而，亚单位组的注射部位硬结更常见（P < 0.05），而 Sub/MF59 组的注射部位轻度疼痛和发热更常见（P < 0.005）。与基线相比，两种疫苗均显著（P < 0.001）增加了三种测试菌株的几何平均滴度（GMT）；Sub/MF59 组的 A/H1N1、A/H3N2 和 B 的 GMT 显著更高（P = 0.034，P < 0.001 和 P = 0.005）。Sub/MF59 组针对 A/H1N1、A/H3N2 和 B 的 GMT 比值也显著更高（P = 0.038，P < 0.001 和 P = 0.006）。同样，Sub/MF59 组在第 22 天达到血清保护或血清转化率的受试者百分比也更高，针对 A/H3N2 的结果具有统计学意义（P < 0.001）。
MF59 佐剂亚单位流感疫苗在老年中国受试者中具有良好的耐受性，在该人群中诱导了比非佐剂亚单位流感疫苗更高水平的免疫原性，该人群患与流感相关的并发症的风险较高。
