Aluminum adjuvant dose guidelines in vaccine formulation for preclinical evaluations

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 indica...

Full description

Saved in:

Bibliographic Details
Published in:	Journal of pharmaceutical sciences Vol. 101; no. 1; p. 17
Main Authors:	Vecchi, Simone, Bufali, Simone, Skibinski, David A G, O'Hagan, Derek T, Singh, Manmohan
Format:	Journal Article
Language:	English
Published:	United States 01-01-2012
Subjects:	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
Online Access:	Get more information
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
Summary:	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.
ISSN:	1520-6017
DOI:	10.1002/jps.22759