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

326941

Sigma-Aldrich

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

266515

Sigma-Aldrich

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

266558

Sigma-Aldrich

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

11009

Sigma-Aldrich

Aluminum, powder, ≥91% (complexometric)

326887

Sigma-Aldrich

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

IRMM523C

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

IRMM523B

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

733369

Sigma-Aldrich

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

653608

Sigma-Aldrich

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

518573

Sigma-Aldrich

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

GF48732532

Aluminum, wire reel, 5m, diameter 0.25mm, as drawn, 99.999%

GF65371327

Aluminum, wire reel, 50m, diameter 0.5mm, as drawn, 99.5%

GF41557035

Aluminum, wire reel, 5m, diameter 0.025mm, as drawn, 99.0+%

GF72634103

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

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%

GF12154171

Aluminum, sphere, 200pcs, diameter 6.0mm, 99%

GF32029444

Aluminum, rod, 100mm, diameter 12.7mm, 99%

GF85927056

Aluminum, microleaf disks, 25mm, thinness 0.5μm, specific density 120.6μg/cm², removable support, 99.999%

GF95825403

Aluminum, sphere, 100pcs, diameter 3.0mm, aluminum alloy 2017 precision sphere, grade 200, 95.2%

GF85983205

Aluminum, microleaf disks, 25mm, thinness 1.0μm, specific density 269.9μg/cm², removable support, 99.999%

GF52495500

Aluminum, tube, 0.1m coil, as drawn, outside diameter 0.30mm, inside diameter 0.2mm, wall thickness 0.05mm, 99.5%

GF93309037

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

GF47839124

Aluminum, insulated wire, 20m, conductor diameter 0.1mm, insulation thickness 0.005mm, polyimide insulation, 99.95+%

GF54273944

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

GF93280732

Aluminum, rod, 500mm, diameter 15.0mm, as drawn, 99.999%

GF36586042

Aluminum, rod, 100mm, diameter 20.0mm, as drawn, 99.999%

GF20784360

Aluminum, sphere, 100pcs, diameter 2.5mm, aluminum alloy 2017 precision sphere, grade 200, 95.2%

GF86733726

Aluminum, rod, 200mm, diameter 15.0mm, as drawn, 99.999%

GF72881297

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