Oral MucoRice-CTB vaccine is safe and immunogenic in healthy US adults.
Vaccine
; 40(24): 3372-3379, 2022 05 26.
Article
em En
| MEDLINE
| ID: mdl-35484039
ABSTRACT
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.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Oryza
/
Vacinas contra Cólera
/
Escherichia coli Enterotoxigênica
Tipo de estudo:
Clinical_trials
Limite:
Female
/
Humans
/
Male
Idioma:
En
Revista:
Vaccine
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Japão