title: Thermostable formulations of a hepatitis B vaccine and a meningitis A polysaccharide conjugate vaccine produced by a spray drying method.
abstract: Thermostable vaccines promise to simplify the logistics of vaccine distribution and expand the immunization coverage. In this study, a pilot-scale spray drying process was developed and used to produce glassy state formulations of a recombinant hepatitis B (HepB) vaccine containing aluminum adjuvant and Neisseria meningitidis A (MenA) protein-polysaccharide conjugate vaccine, representing two common types of subunit vaccines in use today: the spray-dried HepB vaccine formulations were stable for at least 24 months at 37 degrees C while several MenA vaccine formulations exhibited complete stability at temperatures up to 60 degrees C. This study demonstrates the feasibility of producing thermostable vaccines with advanced processing and formulation technologies.
authors.affiliation: PATH, Seattle, WA 98121, USA. dchen@path.org
authors.forename: D
authors.initials: D
authors.lastname: Chen
authors.forename: S
authors.initials: S
authors.lastname: Kapre
authors.forename: A
authors.initials: A
authors.lastname: Goel
authors.forename: K
authors.initials: K
authors.lastname: Suresh
authors.forename: S
authors.initials: S
authors.lastname: Beri
authors.forename: J
authors.initials: J
authors.lastname: Hickling
authors.forename: J
authors.initials: J
authors.lastname: Jensen
authors.forename: M
authors.initials: M
authors.lastname: Lal
authors.forename: J M
authors.initials: JM
authors.lastname: Preaud
authors.forename: M
authors.initials: M
authors.lastname: Laforce
authors.forename: D
authors.initials: D
authors.lastname: Kristensen
mesh_terms: D000276:Adjuvants, Immunologic / Q000494:pharmacology; D017607:Aluminum Compounds / Q000494:pharmacology; D000818:Animals; D001428:Bacterial Vaccines / Q000737:chemistry* / Q000276:immunology / Q000494:pharmacology; D003890:Desiccation; D004355:Drug Stability; D017325:Hepatitis B Vaccines / Q000737:chemistry* / Q000276:immunology / Q000494:pharmacology; D006515:Hepatitis B virus / Q000276:immunology; D051379:Mice; D008807:Mice, Inbred BALB C; D038381:Neisseria meningitidis, Serogroup A / Q000276:immunology; D010865:Pilot Projects; D011134:Polysaccharides / Q000276:immunology; D011208:Powders / Q000494:pharmacology; D013696:Temperature; D018074:Vaccines, Conjugate / Q000737:chemistry / Q000276:immunology / Q000494:pharmacology; D022223:Vaccines, Subunit / Q000737:chemistry / Q000276:immunology / Q000494:pharmacology
chemical_list: D000276:Adjuvants, Immunologic; D017607:Aluminum Compounds; D001428:Bacterial Vaccines; D017325:Hepatitis B Vaccines; D011134:Polysaccharides; D011208:Powders; D018074:Vaccines, Conjugate; D022223:Vaccines, Subunit