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Adju-Phos® Guidelines

Our ADJU-PHOS® series addresses two main applications:

1) Human applications for use in vaccines

2) Experimental immunology

Within these fields ADJU-PHOS® may be used in both basic research and R&D, as well as small and large scale production. ADJU-PHOS® could also be used for the manufacture of veterinary vaccines. However, this application is not yet widespread.

Human applications:

Distinctions are as follows -

1) Profyllactic Vaccines (vaccinating a sound patient to protect against infections).

2) Therapeutic vaccines (vaccinating a patient already sick to cure or treat the disease).

Application of ADJU-PHOS®: Dosing

In veterinary vaccines there is no defined maximum limit for the allowed content of aluminum ADJUVANTS. Here the dose is normally set from a balance between efficacy and local reactogenicity. However, there are limitations for the content of aluminum allowed in vaccines for humans. These limits are 1.25 mg. aluminum per dose in Europe 1, and in USA 0.85 mg. aluminum per dose if determined by assay, 1.14 mg. if determined by calculation and 1.25 mg. if safety and efficacy data justifies it 2.

1 Ph.Eur. 6.ed. (2009) vaccines for human use pp. 3971.
2 Code of Federal Regulations (2009) 21, vil. 7: sec 610.15 (constituent materials) rev. 1. April.

ADJU-PHOS® as ADJUVANT in DNA vaccines:

ADJU-PHOS® has been tested for use in experimental combination vaccines where adsorbed protein vaccines were combined with DNA oligonucleotide vaccines 1. The technology was quite promising in a BALB/c system when using surface and core antigen from hepatitis B virus.

1 Kwissa, M.; Lindblad, E.B.; Schirmbeck, R. and Reimann, J. (2003) Co-delivery of a DNA Vaccine and a Protein Vaccine with Aluminum Phosphate Stimulates a Potent and Multivalent Immune Response. J. Mol. Med. 81:8. 502-511.