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

IRMM523A

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

338788

Sigma-Aldrich

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

266957

Sigma-Aldrich

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

266574

Sigma-Aldrich

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

326852

Sigma-Aldrich

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

326860

Sigma-Aldrich

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

GF70878976

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

GF19881928

Aluminum, honeycomb, 300x300mm, thickness 20mm, cell size 3.2mm, cell wall 0.025mm, core density 0.072g/cm³, phenolic adhesive (resin), 99.5%

GF12106897

Aluminum, foam, 150x150mm, thickness 6.35mm, bulk density 0.2g/cm³, porosity 0.93, 4 pores/cm, 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%

GF31796725

Aluminum, honeycomb, 300x300mm, 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%

GF33055185

Aluminum, foam, 150x150mm, thickness 6.35mm, bulk density 0.2g/cm³, porosity 0.93, 16 pores/cm, aluminum 6101 grade, 98.5%

GF26812043

Aluminum, foam, 150x150mm, thickness 3.2mm, bulk density 0.2g/cm³, porosity 0.93, 16 pores/cm, aluminum 6101 grade, 98.5%

GF51278070

Aluminum, honeycomb, 300x300mm, thickness 10mm, cell size 3.2mm, cell wall 0.025mm, core density 0g/cm³, phenolic adhesive (resin), 99.5%

GF99626103

Aluminum, honeycomb, 600x600mm, thickness 20mm, cell size 4.8mm, cell wall 0.038mm, core density 0.070g/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%

GF04614724

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

GF25360354

Aluminum, rod, 50mm, diameter 30.0mm, as drawn, 99.999%

GF44675781

Aluminum, rod, 1000mm, diameter 12.7mm, 99%

GF20500197

Aluminum, tube, 200mm, outside diameter 1.96mm, inside diameter 1.4mm, wall thickness 0.28mm, as drawn, 99.5%

GF86830566

Aluminum, mesh, 600x600mm, nominal aperture 0.38mm, wire diameter 0.25mm, 40x40 wires/inch, open area 37%, plain weave mesh

GF04746472

Aluminum, tube, 100mm, outside diameter 1.42mm, inside diameter 1.166mm, wall thickness 0.127mm, as drawn, 99.5%

GF31003456

Aluminum, rod, 100mm, diameter 5.0mm, as drawn, 99.999%

GF37288020

Aluminum, rod, 1000mm, diameter 6.0mm, as drawn, 99.999%

GF64700524

Aluminum, rod, 1000mm, diameter 5.0mm, as drawn, 99.999%

GF52964006

Aluminum, tube, 100mm, outside diameter 1.96mm, inside diameter 1.4mm, wall thickness 0.28mm, as drawn, 99.5%

GF98449576

Aluminum, rod, 100mm, diameter 10.0mm, as drawn, 99.999%

GF53989497

Aluminum, microleaf disks, 10mm, thinness 0.5μm, specific density 120.6μg/cm², removable support, 99.999%

GF47667819

Aluminum, microfoil, disks, 10mm, thinness 0.0075μm, specific density 1.84μg/cm², permanent mylar 3.5μm support, 99.999%