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

326860

Sigma-Aldrich

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

266574

Sigma-Aldrich

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

266957

Sigma-Aldrich

Aluminum, foil, thickness 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

IRMM523A

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

GF76115505

Aluminum, tube, 500mm, outside diameter 0.86mm, inside diameter 0.76mm, wall thickness 0.05mm, as drawn, 99.5%

GF58886803

Aluminum, wire reel, 100m, diameter 0.30mm, as drawn, 99.5%

GF63629219

Aluminum, tube, 500mm, outside diameter 1.42mm, inside diameter 1.166mm, wall thickness 0.127mm, as drawn, 99.5%

GF01823284

Aluminum, wire reel, 100m, diameter 0.5mm, as drawn, 99.5%

GF47667819

Aluminum, microfoil, disks, 10mm, thinness 0.0075μm, specific density 1.84μg/cm², permanent mylar 3.5μm support, 99.999%

GF63192371

Aluminum, wire reel, 0.5m, diameter 1.5mm, as drawn, 99.999%

GF38637850

Aluminum, tube, 100mm, outside diameter 3.0mm, inside diameter 1.62mm, wall thickness 0.69mm, hard, 99.5%

GF54777460

Aluminum, microfoil, disks, 50mm, thinness 0.0075μm, specific density 1.84μg/cm², permanent mylar 3.5μm support, 99.999%

GF86639811

Aluminum, wire reel, 5m, diameter 0.25mm, hard, 99.99+%

GF70878976

Aluminum, wire reel, 50m, diameter 0.125mm, as drawn, 99.5%

GF14206047

Aluminum, foam, 33x140mm, thickness 20mm, bulk density 0.2g/cm³, porosity 0.93, aluminum 6101 grade, 98.5%

GF26812043

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

GF51278070

Aluminum, honeycomb, 300x300mm, thickness 10mm, cell size 3.2mm, cell wall 0.025mm, core density 0g/cm³, phenolic adhesive (resin), 99.5%

GF33055185

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

GF00479145

Aluminum, wire reel, 1m, diameter 0.015mm, hard, 99.99%

GF05275403

Aluminum, wire reel, 500m, diameter 1.0mm, as drawn, 99.5%

GF19479594

Aluminum, wire reel, 200m, diameter 0.5mm, as drawn, 99.95+%

GF20922061

Aluminum, wire reel, 35m, diameter 0.05mm, as drawn, 99.99+%

GF82602907

Aluminum, wire reel, 10m, diameter 1.0mm, as drawn, 99.5%

GF44722469

Aluminum, wire reel, 10m, diameter 0.125mm, as drawn, 99.99+%

GF28638692

Aluminum, wire reel, 25m, diameter 0.025mm, as drawn, 99.0+%

GF16762305

Aluminum, wire reel, 1m, diameter 0.5mm, as drawn, 99.999%

GF34949289

Aluminum, wire reel, 500m, diameter 0.5mm, as drawn, 99.95+%

GF93741330

Aluminum, wire reel, 10m, diameter 2.0mm, as drawn, 99.999%