Oral MucoRice-CTB vaccine is safe and immunogenic in healthy US adults
Oral MucoRice-CTB vaccine is safe and immunogenic in healthy US adults
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口服 MucoRice-CTB 疫苗对健康的美国成年人来说是安全的且具有免疫原性
DOI：
10.1016/j.vaccine.2022.04.051
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发表时间：
2022
期刊：
影响因子：
5.5
通讯作者：
Kiyono Hiroshi
中科院分区：
文献类型：
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作者：
Yuki Yoshikazu;Nojima Masanori;Kashima Koji;Sugiura Kotomi;Maruyama Shinichi;Kurokawa Shiho;Yamanoue Tomoyuki;Nakahashi-Ouchida Rika;Nakajima Hiroyuki;Hiraizumi Takashi;Kohno Hitoshi;Goto Eiji;Fujihashi Kohtaro;Kiyono Hiroshi
MucoRice-CTB是一种很有前途的无冷链口服霍乱疫苗候选者。在这里，我们报告了一项在美国进行的双盲、随机、安慰剂对照、I期研究，其中接种6 g剂量的MucoRice-CT B诱导了针对霍乱毒素B亚单位（CT B）和肠促炎性大肠杆菌不耐热肠毒素的交叉反应性抗原特异性抗体，而未诱导严重不良事件。对于健康男性和女性来说，该剂量是可接受的安全且可耐受的。此外，它诱导的CTB特异性伊加反应的唾液中的两个9个治疗的受试者;在一个主题，唾液伊加的免疫动力学类似的血清CTB特异性伊加。来自五名疫苗应答者中的三名的抗体阻止CTB结合其GM 1神经节苷脂受体。这些结果与日本I期研究的结果一致，表明口服MucoRice-CTB可诱导产生针对大肠杆菌毒素的中和抗体，无论种族如何。
MucoRice-CTB is a promising cold-chain-free oral cholera vaccine candidate. Here, we report a double-blind, randomized, placebo-controlled, phase I study conducted in the USA in which vaccination with the 6-g dose of MucoRice-CTB induced cross-reactive antigen-specific antibodies against the B subunit of cholera toxin (CTB) and enterotoxigenicEscherichia coliheat-labile enterotoxin without inducing serious adverse events. This dosage was acceptably safe and tolerable in healthy men and women. In addition, it induced a CTB-specific IgA response in the saliva of two of the nine treated subjects; in one subject, the immunological kinetics of the salivary IgA were similar to those of the serum CTB-specific IgA. Antibodies from three of the five responders to the vaccine prevented CTB from binding its GM1 ganglioside receptor. These results are consistent with those of the phase I study in Japan, suggesting that oral MucoRice-CTB induces neutralizing antibodies against diarrheal toxins regardless of ethnicity.