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

653608

Sigma-Aldrich

Aluminum, powder, <5 μm particle size, 99.5% trace metals basis

11009

Sigma-Aldrich

Aluminum, powder, ≥91% (complexometric)

IRMM523B

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

433705

Sigma-Aldrich

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

326887

Sigma-Aldrich

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

202584

Sigma-Aldrich

Aluminum, powder, <75 μm, ≥99.95% trace metals basis

326941

Sigma-Aldrich

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

266558

Sigma-Aldrich

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

266515

Sigma-Aldrich

Aluminum, ≤30 μm, spherical powder, ≥99%

518573

Sigma-Aldrich

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

IRMM523C

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

733369

Sigma-Aldrich

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

GF72634103

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

GF48798309

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

GF72881297

Aluminum, microfoil, disks, 50mm, thinness 1.0μm, specific density 269.9μg/cm², permanent mylar 3.5μm support, 99.999%

GF98025239

Aluminum, tube, 100mm, outside diameter 0.55mm, inside diameter 0.4mm, wall thickness 0.075mm, as drawn, 99.5%

GF04709695

Aluminum, rod, 44mm, diameter 77.5mm, as drawn, 99.999%

GF02208923

Aluminum, tube, 200mm, outside diameter 0.86mm, inside diameter 0.76mm, wall thickness 0.05mm, as drawn, 99.5%

GF09680306

Aluminum, microfoil, disks, 25mm, thinness 0.0075μm, specific density 1.84μg/cm², permanent mylar 3.5μm support, 99.999%

GF87559420

Aluminum, tube, 0.5m coil, as drawn, outside diameter 0.30mm, inside diameter 0.2mm, wall thickness 0.05mm, 99.5%

GF09755837

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

GF71298546

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

GF49694743

Aluminum, tube, 100mm, outside diameter 0.6mm, inside diameter 0.3mm, wall thickness 0.15mm, as drawn, 99.5%

GF94706354

Aluminum, mesh, 150x150mm, nominal aperture 0.38mm, wire diameter 0.25mm, 40x40 wires/inch, open area 37%, plain weave mesh

GF93309037

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

GF06197014

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

GF54273944

Aluminum, tube, 500mm, outside diameter 0.55mm, inside diameter 0.4mm, wall thickness 0.075mm, as drawn, 99.5%

GF16562246

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

GF95990068

Aluminum, wire reel, 100m, diameter 0.25mm, hard, 99.99+%

GF98718935

Aluminum, sphere, 100pcs, diameter 1.0mm, aluminum alloy 2017 precision sphere, grade 200, 95.2%