Vaccine · 2022
Oral MucoRice-CTB vaccine is safe and immunogenic in healthy US adults.
Клиническое исследование I фазыСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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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
Аннотация
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 enterotoxigenic Escherichia coli heat-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.