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

11009

Sigma-Aldrich

Aluminum, powder, ≥91% (complexometric)

IRMM523C

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

IRMM523B

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

GF12712610

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

GF74087758

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

310360

Sigma-Aldrich

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

GF58303098

Aluminum, wire reel, 500m, diameter 0.5mm, as drawn, 99.5%

GF08278296

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

GF41557035

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

GF72281088

Aluminum, wire reel, 20m, diameter 0.7mm, as drawn, 99.5%

GF95825403

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

GF67949937

Aluminum, wire reel, 5m, diameter 2.0mm, as drawn, 99.999%

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

GF40404574

Aluminum, wire reel, 100m, diameter 0.25mm, as drawn, 99.5%

GF19654803

Aluminum, rod, 200mm, diameter 5.0mm, as drawn, 99.999%

GF12154171

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

GF09680306

Aluminum, microfoil, disks, 25mm, thinness 0.0075μm, specific density 1.84μg/cm², permanent mylar 3.5μm support, 99.999%

GF89906743

Aluminum, wire reel, 30m, diameter 0.063mm, annealed, 99.99%

GF48396730

Aluminum, wire reel, 50m, diameter 1.0mm, as drawn, 99.999%

GF37306267

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

GF26773230

Aluminum, honeycomb, 300x300mm, thickness 13.9mm, cell size 6.3mm, cell wall 0.064mm, core density 0.083g/cm³, phenolic adhesive (resin), facing skin aluminum 0.55mm, 99.9%

GF10029596

Aluminum, foam, 150x150mm, thickness 6.35mm, bulk density 0.2g/cm³, porosity 0.93, 8 pores/cm, aluminum 6101 grade, 98.5%

GF96312326

Aluminum, honeycomb, 600x600mm, thickness 26.5mm, cell size 6.3mm, cell wall 0.064mm, core density 0.083g/cm³, phenolic adhesive (resin), facing skin carbon fiber / epoxy, 99.9%

GF33610395

Aluminum, foam, 300x400mm, thickness 6.35mm, bulk density 0.2g/cm³, porosity 0.93, aluminum 6101 grade, 98.5%

GF85240694

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

GF03467202

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%

GF58771301

Aluminum, honeycomb, 600x600mm, thickness 5mm, cell size 13mm, cell wall 0.1mm, core density 0.062g/cm³, phenolic adhesive (resin), 99.5%

GF23840221

Aluminum, honeycomb, 300x300mm, thickness 26.5mm, cell size 6.3mm, cell wall 0.064mm, core density 0.083g/cm³, phenolic adhesive (resin), facing skin aluminum 0.55mm, 99.9%