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

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)

326887

Sigma-Aldrich

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

433705

Sigma-Aldrich

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

326941

Sigma-Aldrich

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

266558

Sigma-Aldrich

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

733369

Sigma-Aldrich

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

310360

Sigma-Aldrich

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

518573

Sigma-Aldrich

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

GF06074120

Aluminum, wire reel, 0.5m, diameter 1.0mm, as drawn, 99.999%

GF02208923

Aluminum, tube, 200mm, outside diameter 0.86mm, inside diameter 0.76mm, wall thickness 0.05mm, as drawn, 99.5%

GF71298546

Aluminum, wire reel, 100m, diameter 0.063mm, annealed, 99.99%

GF72709151

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

GF88567037

Aluminum, wire reel, 10m, diameter 0.125mm, as drawn, 99.5%

GF65085510

Aluminum, wire reel, 5m, diameter 0.125mm, as drawn, 99.99+%

GF48732532

Aluminum, wire reel, 5m, diameter 0.25mm, as drawn, 99.999%

GF78825998

Aluminum, wire reel, 5m, diameter 3.0mm, as drawn, 99.999%

GF65371327

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

GF11053606

Aluminum, wire reel, 5m, diameter 0.30mm, as drawn, 99.5%

GF41557035

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

GF08278296

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

GF89906743

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

GF75278043

Aluminum, wire reel, 50m, diameter 0.5mm, as drawn, 99.95+%

GF93567921

Aluminum, wire reel, 50m, diameter 0.25mm, hard, 99.99+%

GF01863097

Aluminum, wire reel, 5m, diameter 0.05mm, as drawn, 99.99+%

GF54185474

Aluminum, wire reel, 5m, diameter 0.025mm, as drawn, 99.99+%

266523

Sigma-Aldrich

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

GF31987525

Aluminum, honeycomb, 300x300mm, thickness 10mm, cell size 6.3mm, cell wall 0.064mm, core density 0.083g/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%