title: Evaluation of enteric-coated tablets as a whole cell inactivated vaccine candidate against Vibrio cholerae.
abstract: A vaccine candidate against cholera was developed in the form of oral tablets to avoid difficulties during application exhibited by current whole cell inactivated cholera vaccines. In this study, enteric-coated tablets were used to improve the protection of the active compound from gastric acidity. Tablets containing heat-killed whole cells of Vibrio cholerae strain C7258 as the active pharmaceutical compound was enteric-coated with the polymer Kollicoat(®) MAE-100P, which protected them efficiently from acidity when a disintegration test was carried out. Enzyme-linked immunosorbent assay (ELISA) anti-lipopolysaccharide (LPS) inhibition test and Western blot assay revealed the presence of V. cholerae antigens as LPS, mannose-sensitive haemagglutinin (MSHA) and outer membrane protein U (Omp U) in enteric-coated tablets. Immunogenicity studies (ELISA and vibriocidal test) carried out by intraduodenal administration in rabbits showed that the coating process of tablets did not affect the immunogenicity of V. cholerae-inactivated cells. In addition, no differences were observed in the immune response elicited by enteric-coated or uncoated tablets, particularly because the animal model and immunization route used did not allow discriminating between acid resistances of both tablets formulations in vivo. Clinical studies with volunteers will be required to elucidate this aspect, but the results suggest the possibility of using enteric-coated tablets as a final pharmaceutical product for a cholera vaccine.
authors.affiliation: Microbiology, Finlay Institute, Havana, Cuba. sfernandez@finlay.edu.cu
authors.forename: Sonsire
authors.initials: S
authors.lastname: Fernández
authors.forename: Gemma
authors.initials: G
authors.lastname: Año
authors.forename: Jorge
authors.initials: J
authors.lastname: Castaño
authors.forename: Yadira
authors.initials: Y
authors.lastname: Pino
authors.forename: Evangelina
authors.initials: E
authors.lastname: Uribarri
authors.forename: Luis A
authors.initials: LA
authors.lastname: Riverón
authors.forename: Bárbara
authors.initials: B
authors.lastname: Cedré
authors.forename: Tania
authors.initials: T
authors.lastname: Valmaseda
authors.forename: Gustavo
authors.initials: G
authors.lastname: Falero
authors.forename: José L
authors.initials: JL
authors.lastname: Pérez
authors.forename: Juan F
authors.initials: JF
authors.lastname: Infante
authors.forename: Luis G
authors.initials: LG
authors.lastname: García
authors.forename: Rosa L
authors.initials: RL
authors.lastname: Solís
authors.forename: Gustavo
authors.initials: G
authors.lastname: Sierra
authors.forename: Arturo
authors.initials: A
authors.lastname: Talavera
mesh_terms: D000284:Administration, Oral; D000704:Analysis of Variance; D000818:Animals; D000907:Antibodies, Bacterial / Q000097:blood; D058491:Bacterial Load; D015153:Blotting, Western; D002771:Cholera / Q000517:prevention & control; D022121:Cholera Vaccines / Q000737:chemistry / Q000276:immunology / Q000494:pharmacology*; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D008070:Lipopolysaccharides / Q000276:immunology; D011817:Rabbits; D018709:Statistics, Nonparametric; D013608:Tablets, Enteric-Coated / Q000737:chemistry / Q000494:pharmacology; D015164:Vaccines, Inactivated / Q000737:chemistry / Q000276:immunology / Q000494:pharmacology; D014734:Vibrio cholerae / Q000276:immunology*
chemical_list: D000907:Antibodies, Bacterial; D022121:Cholera Vaccines; D007074:Immunoglobulin G; D008070:Lipopolysaccharides; D013608:Tablets, Enteric-Coated; D015164:Vaccines, Inactivated