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

266574

Sigma-Aldrich

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

338788

Sigma-Aldrich

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

326860

Sigma-Aldrich

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

266957

Sigma-Aldrich

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

326852

Sigma-Aldrich

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

IRMM523A

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

GF14206047

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

GF99626103

Aluminum, honeycomb, 600x600mm, thickness 20mm, cell size 4.8mm, cell wall 0.038mm, core density 0.070g/cm³, phenolic adhesive (resin), 99.5%

GF12106897

Aluminum, foam, 150x150mm, thickness 6.35mm, bulk density 0.2g/cm³, porosity 0.93, 4 pores/cm, aluminum 6101 grade, 98.5%

GF04958084

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

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%

GF18113880

Aluminum, wire reel, 0.5m, diameter 3.0mm, as drawn, 99.999%

GF21518850

Aluminum, wire reel, 1000m, diameter 0.25mm, as drawn, 99.5%

GF09240858

Aluminum, wire reel, 100m, diameter 1.0mm, as drawn, 99.95+%

GF53989497

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

GF86830566

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

GF98449576

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

GF54777460

Aluminum, microfoil, disks, 50mm, thinness 0.0075μm, specific density 1.84μg/cm², permanent mylar 3.5μm support, 99.999%

GF28367860

Aluminum, insulated wire, 5m, conductor diameter 0.1mm, insulation thickness 0.005mm, polyimide insulation, 99.95+%

GF10162066

Aluminum, microleaf disks, 10mm, thinness 0.15μm, specific density 41.28μg/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%

GF66886521

Aluminum, microfoil, disks, 50mm, thinness 0.1μm, specific density 25.6μg/cm², permanent mylar 3.5μm support, 99.999%

GF28435844

Aluminum, microleaf disks, 10mm, thinness 0.25μm, specific density 68.8μg/cm², removable support, 99.999%

GF70044342

Aluminum, rod, 100mm, diameter 30.0mm, as drawn, 99.999%

GF88785725

Aluminum, microfoil, disks, 10mm, thinness 0.1μm, specific density 25.6μg/cm², permanent mylar 3.5μm support, 99.999%

GF64700524

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

GF31003456

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

GF37288020

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

GF02407553

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

GF15743594

Aluminum, wire reel, 1m, diameter 2.0mm, as drawn, 99.999%