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

326887

Sigma-Aldrich

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

266558

Sigma-Aldrich

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

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%

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%

GF87997000

Aluminum, honeycomb, 300x300mm, thickness 20mm, cell size 4.8mm, cell wall 0.038mm, core density 0.070g/cm³, phenolic adhesive (resin), 99.5%

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%

GF10029596

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

GF48798309

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

GF20784360

Aluminum, sphere, 100pcs, diameter 2.5mm, aluminum alloy 2017 precision sphere, grade 200, 95.2%

GF14437975

Aluminum, tube, 1000mm, outside diameter 0.86mm, inside diameter 0.76mm, wall thickness 0.05mm, as drawn, 99.5%

GF04709695

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

GF71298546

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

GF73255237

Aluminum, rod, 200mm, diameter 20.0mm, as drawn, 99.999%

GF53651796

Aluminum, tube, 1000mm, outside diameter 1.42mm, inside diameter 1.166mm, wall thickness 0.127mm, as drawn, 99.5%

GF86572042

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

GF08137166

Aluminum, wire reel, 1000m, diameter 0.7mm, as drawn, 99.5%

GF93309037

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

GF72634103

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

GF62984346

Aluminum, tube, 2m coil, as drawn, outside diameter 0.30mm, inside diameter 0.2mm, wall thickness 0.05mm, 99.5%

GF06197014

Aluminum, rod, 200mm, diameter 10.0mm, as drawn, 99.999%

GF32029444

Aluminum, rod, 100mm, diameter 12.7mm, 99%

GF68037723

Aluminum, wire reel, 1000m, diameter 0.30mm, as drawn, 99.5%

GF28125390

Aluminum, tube, 200mm, outside diameter 0.30mm, inside diameter 0.2mm, wall thickness 0.05mm, as drawn, 99.5%

GF18607473

Aluminum, tube, 1000mm, outside diameter 0.55mm, inside diameter 0.4mm, wall thickness 0.075mm, as drawn, 99.5%

GF21896039

Aluminum, rod, 200mm, diameter 12.0mm, as drawn, 99.999%

GF40404574

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

GF79836654

Aluminum, wire reel, 100m, diameter 0.025mm, as drawn, 99.0+%

GF51598761

Aluminum, rod, 200mm, diameter 12.7mm, 99%

GF36586042

Aluminum, rod, 100mm, diameter 20.0mm, as drawn, 99.999%