Ability of ELISA and a toxin neutralization assay to detect changes in immunogenicity of a recombinant Bacillus anthracis protective antigen vaccine upon storage

Biologicals. 2013 Mar;41(2):111-4. doi: 10.1016/j.biologicals.2012.10.002. Epub 2012 Nov 6.

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.

Publication types

  • Research Support, U.S. Gov't, Non-P.H.S.
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adjuvants, Immunologic / chemistry
  • Aluminum Hydroxide / chemistry
  • Aluminum Hydroxide / immunology
  • Animals
  • Anthrax / immunology
  • Anthrax / microbiology
  • Anthrax / prevention & control
  • Anthrax Vaccines / administration & dosage
  • Anthrax Vaccines / chemistry
  • Anthrax Vaccines / immunology*
  • Antibodies, Bacterial / blood
  • Antibodies, Bacterial / immunology*
  • Antigens, Bacterial / genetics
  • Antigens, Bacterial / immunology*
  • Antigens, Bacterial / toxicity
  • Bacillus anthracis / genetics
  • Bacillus anthracis / immunology
  • Bacterial Toxins / immunology
  • Bacterial Toxins / toxicity
  • Cell Line
  • Cell Survival / drug effects
  • Cell Survival / immunology
  • Drug Storage / methods
  • Enzyme-Linked Immunosorbent Assay / methods*
  • Female
  • Immunization
  • Mice
  • Neutralization Tests / methods*
  • Recombinant Proteins / chemistry
  • Recombinant Proteins / immunology
  • Reproducibility of Results
  • Temperature
  • Time Factors

Substances

  • Adjuvants, Immunologic
  • Anthrax Vaccines
  • Antibodies, Bacterial
  • Antigens, Bacterial
  • Bacterial Toxins
  • Recombinant Proteins
  • anthrax toxin
  • Aluminum Hydroxide