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

326887

Sigma-Aldrich

Aluminum, wire, diam. 0.58 mm, ≥99.99% trace metals basis

433705

Sigma-Aldrich

Aluminum, evaporation slug, diam. × L 6.3 mm × 6.3 mm, 99.999% trace metals basis

326941

Sigma-Aldrich

Aluminum, pellets, 3-8 mesh, ≥99.999% trace metals basis

518573

Sigma-Aldrich

Aluminum, granular, <1 mm, 99.7% trace metals basis

266558

Sigma-Aldrich

Aluminum, wire, diam. 1.0 mm, 99.999% trace metals basis

11009

Sigma-Aldrich

Aluminum, powder, ≥91% (complexometric)

IRMM523C

Aluminum, IRMM^®, certified reference material, 1.0 mm wire

733369

Sigma-Aldrich

Aluminum, foil, thickness 8 μm, 99% trace metals basis

IRMM523B

Aluminum, IRMM^®, certified reference material, 1.0 mm foil

GF23840221

Aluminum, honeycomb, 300x300mm, thickness 26.5mm, cell size 6.3mm, cell wall 0.064mm, core density 0.083g/cm³, phenolic adhesive (resin), facing skin aluminum 0.55mm, 99.9%

GF19760081

Aluminum, honeycomb, 600x600mm, thickness 5mm, cell size 3.2mm, cell wall 0.025mm, core density 0.072g/cm³, phenolic adhesive (resin), 99.5%

GF85240694

Aluminum, honeycomb, 600x600mm, thickness 20mm, cell size 3.2mm, cell wall 0.025mm, core density 0.072g/cm³, phenolic adhesive (resin), 99.5%

GF03467202

Aluminum, honeycomb, 300x300mm, thickness 52.3mm, cell size 6.3mm, cell wall 0.064mm, core density 0.083g/cm³, phenolic adhesive (resin), facing skin glass fiber 0.75mm, 99.9%

GF63970498

Aluminum, honeycomb, 300x300mm, thickness 26.5mm, cell size 6.3mm, cell wall 0.064mm, core density 0.083g/cm³, phenolic adhesive (resin), facing skin carbon fiber / epoxy, 99.9%

GF24569602

Aluminum, foam, 150x150mm, thickness 30mm, bulk density 0.2g/cm³, porosity 0.93, aluminum 6101 grade, 98.5%

GF36470178

Aluminum, honeycomb, 300x300mm, thickness 5mm, cell size 13mm, cell wall 0.1mm, core density 0.062g/cm³, phenolic adhesive (resin), 99.5%

GF31987525

Aluminum, honeycomb, 300x300mm, thickness 10mm, cell size 6.3mm, cell wall 0.064mm, core density 0.083g/cm³, phenolic adhesive (resin), 99.5%

GF68037723

Aluminum, wire reel, 1000m, diameter 0.30mm, as drawn, 99.5%

GF09755837

Aluminum, wire reel, 100m, diameter 0.5mm, as drawn, 99.95+%

GF08137166

Aluminum, wire reel, 1000m, diameter 0.7mm, as drawn, 99.5%

GF91218911

Aluminum, wire reel, 100m, diameter 0.05mm, as drawn, 99.99+%

GF71298546

Aluminum, wire reel, 100m, diameter 0.063mm, annealed, 99.99%

GF40404574

Aluminum, wire reel, 100m, diameter 0.25mm, as drawn, 99.5%

GF72634103

Aluminum, rod, 50mm, diameter 28mm, as drawn, 99.999%

GF93309037

Aluminum, tube, 200mm, outside diameter 1.42mm, inside diameter 1.166mm, wall thickness 0.127mm, as drawn, 99.5%

GF48798309

Aluminum, rod, 100mm, diameter 6.0mm, as drawn, 99.999%

GF62984346

Aluminum, tube, 2m coil, as drawn, outside diameter 0.30mm, inside diameter 0.2mm, wall thickness 0.05mm, 99.5%

GF06197014

Aluminum, rod, 200mm, diameter 10.0mm, as drawn, 99.999%

GF16562246

Aluminum, tube, 500mm, outside diameter 3.0mm, inside diameter 1.62mm, wall thickness 0.69mm, hard, 99.5%

GF82284408

Aluminum, microleaf disks, 25mm, thinness 0.15μm, specific density 41.28μg/cm², removable support, 99.999%