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

733369

Sigma-Aldrich

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

IRMM523B

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

11009

Sigma-Aldrich

Aluminum, powder, ≥91% (complexometric)

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

202584

Sigma-Aldrich

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

326887

Sigma-Aldrich

Aluminum, wire, diam. 0.58 mm, ≥99.99% 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%

433705

Sigma-Aldrich

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

IRMM523C

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

GF47839124

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

GF53821234

Aluminum, mesh, 900x900mm, nominal aperture 0.38mm, wire diameter 0.25mm, 40x40 wires/inch, open area 37%, plain weave mesh

GF84145462

Aluminum, microfoil, disks, 25mm, thinness 1.0μm, specific density 269.9μg/cm², permanent mylar 3.5μm support, 99.999%

GF27426944

Aluminum, insulated wire, 2m, conductor diameter 0.1mm, insulation thickness 0.005mm, polyimide insulation, 99.95+%

GF82284408

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

GF10105524

Aluminum, microleaf disks, 25mm, thinness 0.25μm, specific density 68.8μg/cm², removable support, 99.999%

GF12712610

Aluminum, sphere, 100pcs, diameter 6.0mm, 99%

GF16562246

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

GF85927056

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

GF72709151

Aluminum, rod, 100mm, diameter 28mm, as drawn, 99.999%

GF88323206

Aluminum, wire reel, 500m, diameter 1.0mm, as drawn, 99.95+%

GF44532604

Aluminum, wire reel, 20m, diameter 0.02mm, hard, 99.99%

GF90204038

Aluminum, wire reel, 10m, diameter 1.5mm, as drawn, 99.999%

GF65733958

Aluminum, wire reel, 500m, diameter 0.30mm, as drawn, 99.5%

GF86715029

Aluminum, wire reel, 10m, diameter 0.015mm, hard, 99.99%

GF35183471

Aluminum, wire reel, 2m, diameter 0.25mm, as drawn, 99.999%

GF13033033

Aluminum, wire reel, 200m, diameter 0.25mm, as drawn, 99.95+%

GF47050017

Aluminum, wire reel, 20m, diameter 0.25mm, hard, 99.99+%