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U.S. Department of Health and Human Services

Scientific Publications by FDA Staff

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Vaccine 2009 Jul 16;27(33):4537-42

Comparability of ELISA and toxin neutralization to measure immunogenicity of Protective Antigen in mice, as part of a potency test for anthrax vaccines.

Parreiras PM, Sirota LA, Wagner LD, Menzies SL, Arciniega JL


Complexities of lethal challenge models have prompted the investigation of immunogenicity assays as potency tests of anthrax vaccines. An ELISA and a lethal toxin neutralization assay (TNA) were used to measure antibody response to Protective Antigen (PA) in mice immunized once with either a commercial or a recombinant PA (rPA) vaccine formulated in-house. Even though ELISA and TNA results showed correlation, ELISA results may not be able to accurately predict TNA results in this single immunization model.

Category: Journal Article
PubMed ID: #19501205 DOI: 10.1016/j.vaccine.2009.05.045
Includes FDA Authors from Scientific Area(s): Biologics
Entry Created: 2011-10-04 Entry Last Modified: 2012-08-29