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

266558

Sigma-Aldrich

Aluminum, wire, diam. 1.0 mm, 99.999% 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

518573

Sigma-Aldrich

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

326887

Sigma-Aldrich

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

IRMM523C

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

IRMM523B

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

11009

Sigma-Aldrich

Aluminum, powder, ≥91% (complexometric)

266523

Sigma-Aldrich

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

310360

Sigma-Aldrich

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

GF11053606

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

GF75278043

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

GF65371327

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

GF65085510

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

GF15273929

Aluminum, wire reel, 50m, diameter 1.0mm, as drawn, 99.95+%

GF08278296

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

GF01863097

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

GF44532604

Aluminum, wire reel, 20m, diameter 0.02mm, hard, 99.99%

GF72634103

Aluminum, rod, 50mm, diameter 28mm, as drawn, 99.999%

GF48798309

Aluminum, rod, 100mm, diameter 6.0mm, as drawn, 99.999%

GF98025239

Aluminum, tube, 100mm, outside diameter 0.55mm, inside diameter 0.4mm, wall thickness 0.075mm, as drawn, 99.5%

GF04709695

Aluminum, rod, 44mm, diameter 77.5mm, as drawn, 99.999%

GF85983205

Aluminum, microleaf disks, 25mm, thinness 1.0μm, specific density 269.9μg/cm², removable support, 99.999%

GF87559420

Aluminum, tube, 0.5m coil, as drawn, outside diameter 0.30mm, inside diameter 0.2mm, wall thickness 0.05mm, 99.5%

GF09680306

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

GF02208923

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

GF49694743

Aluminum, tube, 100mm, outside diameter 0.6mm, inside diameter 0.3mm, wall thickness 0.15mm, as drawn, 99.5%

GF86572042

Aluminum, rod, 100mm, diameter 12.0mm, as drawn, 99.999%

GF93309037

Aluminum, tube, 200mm, outside diameter 1.42mm, inside diameter 1.166mm, wall thickness 0.127mm, as drawn, 99.5%

GF12154171

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