Development of an in Vitro-Based Potency Assay for Anthrax Vaccine

Abstract

The potency assay currently used to evaluate consistency of manufacture for the anthrax vaccine is contingent upon meeting specified parameters after statistical analysis of the percent survival and time to death of vaccinated guinea pigs after challenge with spores of a virulent strain of Bacillus anthracis. During the development of a new anthrax vaccine based upon recombinant protective antigen (rPA) adsorbed to aluminum hydroxide gel (Alhydrogel), we found that the serological response of female A/J mice, as measured by a quantitative anti-rPA IgG ELISA, may be an effective method to monitor a manufacturer's consistency for rPA-based vaccines. An advantage of the proposed in vitro-based potency assay is that it will not need stringent biosafety containment measures as required by the current guinea pig potency assay.

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Document Details

Document Type
Technical Report
Publication Date
Feb 08, 2004
Accession Number
ADA429742

Entities

People

  • B. E. Ivins
  • P. F. Fellows
  • S. F. Little
  • S. L. Norris
  • W. M. Webster

Organizations

  • United States Army Medical Research Institute of Infectious Diseases

Tags

Communities of Interest

  • Air Platforms
  • Biomedical

DTIC Thesaurus Topics

  • Aluminum
  • Animals
  • Biomedical Research
  • Body Fluids
  • Cells
  • Consistency
  • Data Science
  • Factor Analysis
  • Information Science
  • Laboratory Animals
  • Linear Regression Analysis
  • Materials
  • Regression Analysis
  • Rodents
  • Standards
  • Statistical Analysis
  • Vaccines

Fields of Study

  • Biology

Readers

  • Critical Infrastructure Protection in CBRN and WMD Threats.
  • Immunology

Technology Areas

  • Biotechnology