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

GF95990068

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

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266523

Sigma-Aldrich

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

733369

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

IRMM523B

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

IRMM523C

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

11009

Sigma-Aldrich

Aluminum, powder, ≥91% (complexometric)

266558

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326887

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433705

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

326941

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

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

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

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Aluminum, wire reel, 5m, diameter 1.0mm, as drawn, 99.999%

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Aluminum, honeycomb, 300x300mm, thickness 52.3mm, cell size 6.3mm, cell wall 0.064mm, core density 0.083g/cm³, phenolic adhesive (resin), facing skin glass fiber 0.75mm, 99.9%

GF33400224

Aluminum, honeycomb, 600x600mm, thickness 52.3mm, cell size 6.3mm, cell wall 0.064mm, core density 0.083g/cm³, phenolic adhesive (resin), facing skin glass fiber 0.75mm, 99.9%

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Aluminum, foam, 150x150mm, thickness 6.35mm, bulk density 0.2g/cm³, porosity 0.93, 2 pores/cm, aluminum 6101 grade, 98.5%