Aluminum Adjuvant Dose Guidelines in Vaccine Formulation for Preclinical Evaluations

J Pharm Sci. 2012 Jan;101(1):17-20. doi: 10.1002/jps.22759. Epub 2011 Sep 14.

Abstract

Aluminum (Al) salt-based adjuvants are present in a large variety of licensed vaccines and their use is widely considered for formulations in clinical trials. Although the regulatory agencies have clearly stated the acceptable levels of Al salts in vaccines for human use, there are no general indications for preclinical research. This brief commentary reviews the current status of Al concentrations in licensed vaccines, the related potential toxicity in preclinical species, and proposes a general guideline for selection of suitable Al salt levels in preclinical models, focusing on the formulation development for recombinant protein antigens. A table with conversion factors is included in order to provide a tool for calculation of doses with different Al salts.

Publication types

  • Review

MeSH terms

  • Adjuvants, Immunologic / administration & dosage
  • Adjuvants, Immunologic / chemistry*
  • Adjuvants, Immunologic / standards*
  • Aluminum / administration & dosage
  • Aluminum / adverse effects
  • Aluminum / chemistry*
  • Aluminum / standards*
  • Animals
  • Chemistry, Pharmaceutical / methods
  • Drug Evaluation, Preclinical / methods
  • Humans
  • Vaccines / administration & dosage
  • Vaccines / chemistry*
  • Vaccines / standards*

Substances

  • Adjuvants, Immunologic
  • Vaccines
  • Aluminum