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

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

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

IRMM523A

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

GF88696928

Aluminum, wire reel, 25m, diameter 0.125mm, as drawn, 99.5%

GF22816830

Aluminum, wire reel, 50m, diameter 0.25mm, as drawn, 99.95+%

GF89409673

Aluminum, wire reel, 500m, diameter 0.125mm, as drawn, 99.5%

GF70878976

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

GF86639811

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

GF59893723

Aluminum, wire reel, 5m, diameter 0.015mm, hard, 99.99%

GF87322002

Aluminum, wire reel, 70m, diameter 0.05mm, as drawn, 99.99+%

GF10973550

Aluminum, wire reel, 50m, diameter 0.5mm, as drawn, 99.999%

GF58886803

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

GF80901637

Aluminum, tube, 200mm, outside diameter 0.55mm, inside diameter 0.4mm, wall thickness 0.075mm, as drawn, 99.5%

GF40979773

Aluminum, rod, 500mm, diameter 6.0mm, as drawn, 99.999%

GF21371082

Aluminum, wire reel, 100m, diameter 0.7mm, as drawn, 99.5%

GF80418269

Aluminum, tube, 500mm, outside diameter 0.6mm, inside diameter 0.3mm, wall thickness 0.15mm, as drawn, 99.5%

GF70280669

Aluminum, tube, 1000mm, outside diameter 3.0mm, inside diameter 1.62mm, wall thickness 0.69mm, hard, 99.5%

GF18113880

Aluminum, wire reel, 0.5m, diameter 3.0mm, as drawn, 99.999%

GF70442209

Aluminum, wire reel, 100m, diameter 1.0mm, as drawn, 99.5%

GF49592076

Aluminum, wire reel, 100m, diameter 1.0mm, as drawn, 99.999%

GF21518850

Aluminum, wire reel, 1000m, diameter 0.25mm, as drawn, 99.5%

GF52104260

Aluminum, wire reel, 100m, diameter 0.25mm, as drawn, 99.95+%

GF09240858

Aluminum, wire reel, 100m, diameter 1.0mm, as drawn, 99.95+%

GF98757770

Aluminum, wire reel, 1000m, diameter 0.25mm, as drawn, 99.95+%

GF87115271

Aluminum, wire reel, 100m, diameter 0.125mm, as drawn, 99.5%

GF15743594

Aluminum, wire reel, 1m, diameter 2.0mm, as drawn, 99.999%

GF32887244

Aluminum, wire reel, 10m, diameter 0.05mm, as drawn, 99.99+%