title: The immunogenicity of thin-film freeze-dried, aluminum salt-adjuvanted vaccine when exposed to different temperatures.
abstract: Insoluble aluminum salts such as aluminum oxyhydroxide have been used for decades as adjuvants in human vaccines, and many vaccines contain aluminum salts as adjuvants. Aluminum salt-adjuvanted vaccines must be managed in cold-chain (2-8° C) during transport and storage, as vaccine antigens in general are too fragile to be stable in ambient temperatures, and unintentional slowing freezing causes irreversible aggregation and permanent damage to the vaccines. Previously, we reported that thin-film freeze-drying can be used to convert vaccines adjuvanted with an aluminum salt from liquid suspension into dry powder without causing particle aggregation or decreasing in immunogenicity following reconstitution. In the present study, using ovalbumin (OVA)-adsorbed Alhydrogel® (i.e. aluminum oxyhydroxide, 2% w/v) as a model vaccine, we showed that the immunogenicity of thin-film freeze-dried OVA-adsorbed Alhydrogel® vaccine powder was not significantly changed after it was exposed for an extended period of time in temperatures as high as 40° C or subjected to repeated slow freezing-and-thawing. It is expected that immunization programs can potentially benefit by integrating thin-film freeze-drying into vaccine preparations.
authors.affiliation: a The University of Texas at Austin, College of Pharmacy, Pharmaceutics Division , Austin , TX , USA.
authors.forename: Sachin G
authors.initials: SG
authors.lastname: Thakkar
authors.affiliation: a The University of Texas at Austin, College of Pharmacy, Pharmaceutics Division , Austin , TX , USA.
authors.forename: Tinashe B
authors.initials: TB
authors.lastname: Ruwona
authors.affiliation: a The University of Texas at Austin, College of Pharmacy, Pharmaceutics Division , Austin , TX , USA.
authors.forename: Robert O
authors.initials: RO
authors.lastname: Williams
authors.affiliation: a The University of Texas at Austin, College of Pharmacy, Pharmaceutics Division , Austin , TX , USA.
authors.forename: Zhengrong
authors.initials: Z
authors.lastname: Cui
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000528:radiation effects*; D000536:Aluminum Hydroxide / Q000008:administration & dosage / Q000528:radiation effects*; D000818:Animals; D005260:Female; D005612:Freeze Drying; D008807:Mice, Inbred BALB C; D010047:Ovalbumin / Q000008:administration & dosage / Q000276:immunology / Q000528:radiation effects; D013696:Temperature; D064166:Vaccine Potency; D014612:Vaccines / Q000008:administration & dosage / Q000276:immunology* / Q000528:radiation effects*
chemical_list: D000276:Adjuvants, Immunologic; D014612:Vaccines; D000536:Aluminum Hydroxide; D010047:Ovalbumin
keywords: aluminum oxyhydroxide; antibody responses; antigen desorption; particle aggregation; thin-film freeze-drying