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.

MATERIALI

Numero di prodotto

Marchio

Descrizione del prodotto

266523

Sigma-Aldrich

Aluminum, ReagentPlus^®, beads, 5-15 mm, 99.9% trace metals basis

518573

Sigma-Aldrich

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

266558

Sigma-Aldrich

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

326852

Sigma-Aldrich

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

338788

Sigma-Aldrich

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

266574

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

310360

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Aluminum, ACS reagent, 99%, wire, wire diam. ~1.5 mm

326860

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

733369

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

326887

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

326941

Sigma-Aldrich

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

433705

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

GF29732496

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

266957

Sigma-Aldrich

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

GF44675781

Aluminum, rod, 1000mm, diameter 12.7mm, 99%

GF20784360

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

GF94706354

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

GF85240694

Aluminum, honeycomb, 600x600mm, thickness 20mm, cell size 3.2mm, cell wall 0.025mm, core density 0.072g/cm³, phenolic adhesive (resin), 99.5%

GF38294646

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

GF74087758

Aluminum, wire reel, 1m, diameter 0.02mm, hard, 99.99%

IRMM523B

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

GF98718935

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

GF53821234

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

GF24569602

Aluminum, foam, 150x150mm, thickness 30mm, bulk density 0.2g/cm³, porosity 0.93, aluminum 6101 grade, 98.5%

GF02417677

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

IRMM523A

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

GF26812043

Aluminum, foam, 150x150mm, thickness 3.2mm, bulk density 0.2g/cm³, porosity 0.93, 16 pores/cm, aluminum 6101 grade, 98.5%

GF51598761

Aluminum, rod, 200mm, diameter 12.7mm, 99%

GF33055185

Aluminum, foam, 150x150mm, thickness 6.35mm, bulk density 0.2g/cm³, porosity 0.93, 16 pores/cm, aluminum 6101 grade, 98.5%

GF86118969

Aluminum, honeycomb, 300x300mm, thickness 5mm, cell size 19mm, cell wall 0.064mm, core density 0.029g/cm³, phenolic adhesive (resin), 99.5%