title: Evaluation of a botulinum fragment C-based ELISA for measuring the humoral immune response in primates.
abstract: An enzyme-linked immunosorbent assay (ELISA) using botulinum neurotoxin serotype B recombinant fragment C (rBoNTB(HC)) was developed to measure specific humoral immune responses of monkeys vaccinated with a vaccine consisting of rBoNTB(HC). Several fundamental parameters for a bioassay were evaluated. The evaluation results demonstrated that using BoNTB(HC) as the capture antigen led to a specific and sensitive ELISA for botulinum type B antibody with excellent precision, accuracy, and linearity. There was a good correlation (r=0.91) between ELISA titers and neutralization bioassay titers. Experimental results suggested that the ELISA could be useful for detecting botulinum type B antibody levels and may supplement mouse neutralization bioassays during planned clinical manufacturing and clinical trials of rBoNTB(HC) vaccine.
authors.affiliation: Office of Product Development and Regulatory Affairs, US Army Medical Research Institute of Infectious Diseases, 1425 Porter Street, Fort Detrick, MD 21702-5011, USA. changhong.lindsey@amedd.army.mil
authors.forename: Changhong Y
authors.initials: CY
authors.lastname: Lindsey
authors.forename: Leonard A
authors.initials: LA
authors.lastname: Smith
authors.forename: Michael W
authors.initials: MW
authors.lastname: West
authors.forename: James W
authors.initials: JW
authors.lastname: Boles
authors.forename: J Edward
authors.initials: JE
authors.lastname: Brown
mesh_terms: D000818:Animals; D000917:Antibody Formation; D001905:Botulinum Toxins / Q000276:immunology*; D002138:Calibration; D009500:Neutralization Tests; D011323:Primates; D015203:Reproducibility of Results
chemical_list: D001905:Botulinum Toxins; C096324:botulinum toxin type C