Rapidly produced SAM(®) vaccine against H7N9 influenza is immunogenic in mice.
Rapidly produced SAM(®) vaccine against H7N9 influenza is immunogenic in mice.
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DOI：
10.1038/emi.2013.54
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发表时间：
2013-08
影响因子：
13.2
通讯作者：
Geall, Andrew J.
中科院分区：
文献类型：
--
作者：
Hekele, Armin;Bertholet, Sylvie;Archer, Jacob;Gibson, Daniel G.;Palladino, Giuseppe;Brito, Luis A.;Otten, Gillis R.;Brazzoli, Michela;Buccato, Scilla;Bonci, Alessandra;Casini, Daniele;Maione, Domenico;Qi, Zhi-Qing;Gill, John E.;Caiazza, Nicky C.;Urano, Jun;Hubby, Bolyn;Gao, George F.;Shu, Yuelong;De Gregorio, Ennio;Mandl, Christian W.;Mason, Peter W.;Settembre, Ethan C.;Ulmer, Jeffrey B.;Venter, J. Craig;Dormitzer, Philip R.;Rappuoli, Rino;Geall, Andrew J.
疫苗可获得的时间节点对于有效应对大流行性流感至关重要。2009年，疫苗在疾病高峰期之后才得以供应，这推动了下一代疫苗技术的研发，以实现更快速的应对。目前处于临床前研发阶段的SAM®疫苗平台基于一种由合成脂质纳米颗粒（LNP）递送的合成的自扩增信使核糖核酸（mRNA）。当用于表达季节性流感血凝素（HA）时，一种SAM疫苗引发了强烈的免疫反应，与一种已获许可的流感亚单位疫苗制剂所引发的反应相当。当来自中国H7N9流感疫情的编码血凝素和神经氨酸酶（NA）基因的序列被发布在一个基于网络的数据共享系统上时，快速准确的无细胞基因合成与SAM疫苗技术相结合，使得在8天内就生产出了一种候选疫苗。首次免疫两周后，小鼠体内产生了可测量的针对新病毒的血凝素抑制（HI）和中和抗体滴度。第二次免疫两周后，所有小鼠的HI滴度都达到了被认为具有保护作用的水平。如果SAM疫苗平台在人体中被证明是安全、有效、耐受性良好的，那么全合成疫苗技术可以提供无与伦比的响应速度，以遏制流感爆发的初期浪潮，使得在发现一种新病毒几天后就能首次获得候选疫苗。
The timing of vaccine availability is essential for an effective response to pandemic influenza. In 2009, vaccine became available after the disease peak, and this has motivated the development of next generation vaccine technologies for more rapid responses. The SAM® vaccine platform, now in pre-clinical development, is based on a synthetic, self-amplifying mRNA, delivered by a synthetic lipid nanoparticle (LNP). When used to express seasonal influenza hemagglutinin (HA), a SAM vaccine elicited potent immune responses, comparable to those elicited by a licensed influenza subunit vaccine preparation. When the sequences coding for the HA and neuraminidase (NA) genes from the H7N9 influenza outbreak in China were posted on a web-based data sharing system, the combination of rapid and accurate cell-free gene synthesis and SAM vaccine technology allowed the generation of a vaccine candidate in 8 days. Two weeks after the first immunization, mice had measurable hemagglutinin inhibition (HI) and neutralizing antibody titers against the new virus. Two weeks after the second immunization, all mice had HI titers considered protective. If the SAM vaccine platform proves safe, potent, well tolerated and effective in humans, fully synthetic vaccine technologies could provide unparalleled speed of response to stem the initial wave of influenza outbreaks, allowing first availability of a vaccine candidate days after the discovery of a new virus.
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