A Cell Culture-Derived MF59-Adjuvanted Pandemic A/H7N9 Vaccine Is Immunogenic in Adults
A Cell Culture-Derived MF59-Adjuvanted Pandemic A/H7N9 Vaccine Is Immunogenic in Adults
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DOI：
10.1126/scitranslmed.3008761
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发表时间：
2014-04-30
影响因子：
17.1
通讯作者：
Kanesa-thasan, Niranjan
中科院分区：
文献类型：
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作者：
Bart, Stephan A.;Hohenboken, Matthew;Kanesa-thasan, Niranjan
一种可能致命的A/H7N9禽源流感病毒目前是中国持续爆发的原因。因此，已经启动了防备计划，以预防这种病毒的传播，这种病毒似乎有很大的流行潜力。为了有效地防止大流行的展开，快速生产具有可接受的安全性特征的免疫原性疫苗是至关重要的。鉴于对公共卫生的重要性，我们正在报告一项在健康成人中进行的1期研究的免疫原性和安全性结果，该研究使用了四种灭活A/H7N9疫苗制剂之一。三种制剂含有增加量的抗原和水包油佐剂MF 59，一种制剂仅含有最大剂量的抗原而不含佐剂。所有疫苗制剂均使用合成病毒种子技术结合细胞培养方法获得;与常规方法相比，这些技术已被证明可加快疫苗生产。与无佐剂A/H7N9疫苗相比，MF 59佐剂疫苗观察到更高的应答，在对H7N9病毒没有预先存在的免疫力的大多数受试者中，两次剂量后具有显著和潜在的保护性免疫应答。此外，尽管使用MF 59增加了注射部位疼痛和其他轻度作用，但所有制剂均耐受良好。这些关于A/H7N9疫苗的令人鼓舞的免疫原性和安全性数据为进一步的临床开发提供了强有力的依据。通过使用合成种子/细胞培养技术，我们现在距离使用经过临床测试的A/H7 N9疫苗快速、可靠地应对潜在的H7 N9大流行又近了一步。
A potentially deadly A/H7N9 avian-origin influenza virus is currently the cause of an ongoing outbreak in China. Preparedness plans have thus been initiated to preempt the spread of this virus, which appears to have substantial pandemic potential. To effectively prevent a pandemic from unfolding, rapid production of an immunogenic vaccine with an acceptable safety profile is critical. Given the significance to public health, we are reporting immunogenicity and safety results from a phase 1 study in healthy adults administered one of four inactivated A/H7N9 vaccine formulations. Three formulations contained increasing quantities of antigen and of an oil-in-water adjuvant, MF59, and one formulation contained only the maximum dose of antigen without adjuvant. All vaccine formulations were derived using a synthetic virus seed technology in combination with a cell culture approach; together, these techniques have been shown to expedite vaccine production compared to conventional methods. Higher responses were seen with the MF59-adjuvanted versus the nonadjuvanted A/H7N9 vaccine, with significant and potentially protective immune responses after two doses in most subjects with no preexisting immunity to the H7N9 virus. Further, despite increased injection site pain and other mild effects with MF59, all formulations were well tolerated. These encouraging immunogenicity and safety data on the A/H7N9 vaccine provide a strong rationale for further clinical development. By also using synthetic seed/cell culture technology, we are now one step closer to being able to rapidly and reliably respond to a potential H7N9 pandemic using a clinically tested A/H7N9 vaccine.