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

GF28435844

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

GF02417677

Aluminum, tube, 100mm, outside diameter 0.86mm, inside diameter 0.76mm, wall thickness 0.05mm, as drawn, 99.5%

GF97088068

Aluminum, rod, 500mm, diameter 12.0mm, as drawn, 99.999%

GF02018236

Aluminum, rod, 50mm, diameter 20.0mm, as drawn, 99.999%

GF64700524

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

GF20500197

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

GF20899604

Aluminum, rod, 200mm, diameter 6.0mm, as drawn, 99.999%

GF53989497

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

GF14472266

Aluminum, rod, 50mm, diameter 25.0mm, as drawn, 99.999%

GF37288020

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

GF31003456

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

GF29732496

Aluminum, tube, 200mm, outside diameter 3.0mm, inside diameter 1.62mm, wall thickness 0.69mm, hard, 99.5%

GF35425009

Aluminum, tube, 100mm, outside diameter 0.30mm, inside diameter 0.2mm, wall thickness 0.05mm, as drawn, 99.5%

GF70044342

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

GF98449576

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

GF01823284

Aluminum, wire reel, 100m, diameter 0.5mm, 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%

GF38637850

Aluminum, tube, 100mm, outside diameter 3.0mm, inside diameter 1.62mm, wall thickness 0.69mm, hard, 99.5%

GF61103146

Aluminum, wire reel, 100m, diameter 0.125mm, as drawn, 99.99+%

GF38294646

Aluminum, mesh, 300x300mm, nominal aperture 0.38mm, wire diameter 0.25mm, 40x40 wires/inch, open area 37%, plain weave mesh

GF74626342

Aluminum, rod, 500mm, diameter 10.0mm, as drawn, 99.999%

GF88510383

Aluminum, tube, 1m coil, as drawn, outside diameter 0.30mm, inside diameter 0.2mm, wall thickness 0.05mm, 99.5%

GF24582900

Aluminum, wire reel, 0.2m, diameter 3.0mm, as drawn, 99.999%

GF15509101

Aluminum, tube, 1000mm, outside diameter 1.96mm, inside diameter 1.4mm, wall thickness 0.28mm, as drawn, 99.5%

GF59425476

Aluminum, wire reel, 1000m, diameter 1.0mm, as drawn, 99.5%

GF70280669

Aluminum, tube, 1000mm, outside diameter 3.0mm, inside diameter 1.62mm, wall thickness 0.69mm, hard, 99.5%

GF06754013

Aluminum, rod, 100mm, diameter 15.0mm, as drawn, 99.999%

GF52283404

Aluminum, tube, 1000mm, outside diameter 0.6mm, inside diameter 0.3mm, wall thickness 0.15mm, as drawn, 99.5%

GF58886803

Aluminum, wire reel, 100m, diameter 0.30mm, as drawn, 99.5%