In vitro assay for quantitating secreted antibodies in lymphocyte supernatant for evaluation of vaccine or antigen induced specific antibody secretion from ex vivo circulating antibody-secreting lymphocytes
a lymphocyte and supernatant technology, applied in the field of vaccines and epidemiology, can solve the problem of inability to distinguish between recently produced antibodies and preexisting antibodies
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[0042]I. Human Exposure to Antigen Via Vaccine Clinical Trial:
[0043]ALS assay for V. cholerae antitoxin IgA and IgG during an oral cholera vaccine clinical trial: To apply the ALS assay for measurement of the antigen-induced specific humoral response, PBMC samples were collected during a safety and immunogenicity trial of an oral killed cholera vaccine in healthy adult volunteers. A standard liquid formulation of the vaccine and a spray dry formulation of the vaccine were compared. The liquid formulation was stored continuously at 4° C., but the dry vaccine was placed at room temperature for 30 days. Volunteers were randomized to receive two doses of either vaccine in a double-blind manner. Healthy volunteers between 18 and 50 years of age were recruited from the Baltimore area. Each volunteer received two doses of vaccine. Serum and PBMC were collected at days 0, 14, 21, and 24 after administration of dose one. The ALS assay was used to measure antitoxin IgA and IgG. (The complete ...
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