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Preparation and evaluation of a freeze-dried oral killed cholera vaccine formulation

Journal article
Authors Annika Borde
Anette Larsson
Jan Holmgren
Erik Nygren
Published in European journal of pharmaceutics and biopharmaceutics
Volume 79
Issue 3
Pages 508-518
ISSN 0939-6411
Publication year 2011
Published at Institute of Biomedicine, Department of Microbiology and Immunology
Pages 508-518
Language en
Links dx.doi.org/10.1016/j.ejpb.2011.06.0...
Keywords Freeze-drying, Stabilization, Mannitol, Sucrose, Trehalose, Vibrio, cholerae, toxin b-subunit, vibrio-cholerae, field trial, escherichia-coli, immunization, antibodies, bangladesh, membranes, risk, Administration, Oral, Animals, Antibodies, Bacterial, biosynthesis, blood, Calorimetry, Differential Scanning, Chemistry, Pharmaceutical, Cholera Toxin, immunology, Cholera Vaccines, administration & dosage, chemistry, immunology, Enzyme-Linked Immunosorbent Assay, Freeze Drying, Immunoglobulin A, biosynthesis, blood, Intestine, Small, immunology, Lipopolysaccharides, immunology, Mice, Mice, Inbred BALB C, Microscopy, Electron, Scanning, Surface Properties, Technology, Pharmaceutical, Vaccines, Inactivated, administration & dosage, chemistry, immunology, Vibrio cholerae, immunology, X-Ray Diffraction
Subject categories Microbiology in the medical area, Pharmaceutics, Chemical Sciences

Abstract

Different oral liquid cholera vaccines have proved to be safe and effective, but their formulations present problems for use in low-income countries, since large package volumes have to be transported and cold chain maintenance is required. A solid state formulation would here be more advantageous, and consequently, the possibility to develop a dry cholera vaccine formulation by freeze-drying was investigated. The ability of sucrose, trehalose and mannitol to provide process stabilization during freeze-drying was tested on a formalin-killed whole-cell Vibrio cholerae model vaccine. A matrix of sucrose or trehalose prevented bacterial aggregation, preserved cell morphology and maintained practically completely the protective lipopolysaccharide (LPS) antigen on the cell surface and its reactivity with specific antibody in vitro. After reconstitution, this formulation also retained the capacity to elicit a strong serum and gut mucosal anti-LPS antibody response in orally immunized mice, as compared to the corresponding liquid vaccine formulation. The full preservation of the in vivo immunogenicity was also maintained when the internationally widely licensed oral cholera vaccine Dukoral (TM), which comprises a cocktail of inactivated V. cholerae together with cholera toxin B-subunit (CTB), was freeze-dried using sucrose for stabilization. Thus, we present a process generating a dry oral inactivated whole-cell cholera vaccine formulation with attractive features for public health use in cholera-afflicted settings.

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