Oral MucoRice-CTB vaccine is safe and immunogenic in healthy US adults

Academic Article


  • 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.
  • Published In

  • Vaccine  Journal
  • Digital Object Identifier (doi)

    Author List

  • Yuki Y; Nojima M; Kashima K; Sugiura K; Maruyama S; Kurokawa S; Yamanoue T; Nakahashi-Ouchida R; Nakajima H; Hiraizumi T
  • Start Page

  • 3372
  • End Page

  • 3379
  • Volume

  • 40
  • Issue

  • 24