Aluminum adjuvant dose guidelines in vaccine formulation for preclinical evaluations.

Aluminum adjuvant dose guidelines in vaccine formulation for preclinical evaluations.

Journal of pharmaceutical sciences (2011-09-16)

Simone Vecchi, Simone Bufali, David A G Skibinski, Derek T O'Hagan, Manmohan Singh

PMID21918987

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.

MATERIALS

Product Number

Brand

Product Description

01-2570

Sigma-Aldrich

Aluminum, CP

326852

Sigma-Aldrich

Aluminum, foil, thickness 0.25 mm, 99.999% trace metals basis

266574

Sigma-Aldrich

Aluminum, foil, thickness 0.45-0.55 mm, 99.999% trace metals basis

266957

Sigma-Aldrich

Aluminum, foil, thickness 1.0 mm, 99.999% trace metals basis

326860

Sigma-Aldrich

Aluminum, foil, thickness 0.13 mm, ≥99.99% trace metals basis

338788

Sigma-Aldrich

Aluminum, pellets, 3-12 mm, 99.99% trace metals basis

IRMM523A

Aluminum, IRMM^®, certified reference material, 0.1 mm foil

GF90308538

Aluminum, wire reel, 50m, diameter 0.125mm, as drawn, 99.99+%

GF86639811

Aluminum, wire reel, 5m, diameter 0.25mm, hard, 99.99+%

GF70878976

Aluminum, wire reel, 50m, diameter 0.125mm, as drawn, 99.5%

GF04614724

Aluminum, honeycomb, 600x600mm, thickness 10mm, cell size 3.2mm, cell wall 0.025mm, core density 0g/cm³, phenolic adhesive (resin), 99.5%

GF04958084

Aluminum, honeycomb, 300x300mm, thickness 5mm, cell size 3.2mm, cell wall 0.025mm, core density 0.072g/cm³, phenolic adhesive (resin), 99.5%

GF14206047

Aluminum, foam, 33x140mm, thickness 20mm, bulk density 0.2g/cm³, porosity 0.93, aluminum 6101 grade, 98.5%

GF70010222

Aluminum, honeycomb, 150x150mm, thickness 10mm, cell size 3.2mm, cell wall 0.025mm, core density 0g/cm³, phenolic adhesive (resin), 99.5%

GF74590724

Aluminum, honeycomb, 600x600mm, thickness 26.5mm, cell size 6.3mm, cell wall 0.064mm, core density 0.083g/cm³, phenolic adhesive (resin), facing skin glass fiber 0.5mm, 99.9%

GF46654375

Aluminum, honeycomb, 600x600mm, thickness 13.9mm, cell size 6.3mm, cell wall 0.064mm, core density 0.083g/cm³, phenolic adhesive (resin), facing skin aluminum 0.55mm, 99.9%

GF07499010

Aluminum, foam, 150x150mm, thickness 10mm, bulk density 0.2g/cm³, porosity 0.93, aluminum 6101 grade, 98.5%

GF98757770

Aluminum, wire reel, 1000m, diameter 0.25mm, as drawn, 99.95+%

GF29976407

Aluminum, wire reel, 10m, diameter 0.25mm, hard, 99.99+%

GF55775470

Aluminum, wire reel, 10m, diameter 0.7mm, as drawn, 99.5%

GF28638692

Aluminum, wire reel, 25m, diameter 0.025mm, as drawn, 99.0+%

GF82602907

Aluminum, wire reel, 10m, diameter 1.0mm, as drawn, 99.5%