title: Ability of ELISA and a toxin neutralization assay to detect changes in immunogenicity of a recombinant Bacillus anthracis protective antigen vaccine upon storage.
abstract: We examined the capability of a mouse immunogenicity assay to detect improper storage of a recombinant protective antigen (rPA)-based anthrax vaccine formulated with an aluminum adjuvant, using ELISA and a toxin neutralization assay (TNA) to measure the antibody response to rPA. The vaccine was stored at 4 °C, room temperature (RT) or 37 °C for one, four and eight weeks and used for immunization, along with freshly prepared vaccine. Results showed that, contrary to ELISA, TNA is suitable to detect a loss of immunogenicity of the rPA vaccine following its exposure to RT for a period of eight weeks and to 37 °C for a period as short as 1 week.
authors.affiliation: Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Mail Code HFM-443, Rockville, MD 20852, USA.
authors.forename: Rocío I
authors.initials: RI
authors.lastname: Domínguez-Castillo
authors.forename: Anita
authors.initials: A
authors.lastname: Verma
authors.forename: Juan C
authors.initials: JC
authors.lastname: Amador-Molina
authors.forename: Lev
authors.initials: L
authors.lastname: Sirota
authors.forename: Juan L
authors.initials: JL
authors.lastname: Arciniega
mesh_terms: D000276:Adjuvants, Immunologic / Q000737:chemistry; D000536:Aluminum Hydroxide / Q000737:chemistry / Q000276:immunology; D000818:Animals; D000881:Anthrax / Q000276:immunology / Q000382:microbiology / Q000517:prevention & control; D022122:Anthrax Vaccines / Q000008:administration & dosage / Q000737:chemistry / Q000276:immunology*; D000907:Antibodies, Bacterial / Q000097:blood / Q000276:immunology*; D000942:Antigens, Bacterial / Q000235:genetics / Q000276:immunology* / Q000633:toxicity; D001408:Bacillus anthracis / Q000235:genetics / Q000276:immunology; D001427:Bacterial Toxins / Q000276:immunology / Q000633:toxicity; D002460:Cell Line; D002470:Cell Survival / Q000187:drug effects / Q000276:immunology; D004356:Drug Storage / Q000379:methods; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D007114:Immunization; D051379:Mice; D009500:Neutralization Tests / Q000379:methods*; D011994:Recombinant Proteins / Q000737:chemistry / Q000276:immunology; D015203:Reproducibility of Results; D013696:Temperature; D013997:Time Factors
chemical_list: D000276:Adjuvants, Immunologic; D022122:Anthrax Vaccines; D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; D001427:Bacterial Toxins; D011994:Recombinant Proteins; C030325:anthrax toxin; D000536:Aluminum Hydroxide