AddaVax™

Vaccine Adjuvant: Squalene-Oil-in-water

AddaVax™ is a squalene-based oil-in-water nano-emulsion with a formulation similar to that of MF59® that has been licensed in Europe for adjuvanted flu vaccines [1]. Squalene is an oil more readily metabolized than the paraffin oil used in Freund’s adjuvants [1]. Squalene oil-in-water emulsions, such as MF59®, elicit both cellular (Th1) and humoral (Th2) immune responses [2, 3].

This class of adjuvants is believed to act through recruitment and activation of APC and stimulation of cytokines and chemokines production by macrophages and granulocytes [1].
 

AddaVax™ is VacciGrade™, a high-quality pre-clinical grade.

AddaVax™ is for research use only, and not for human or veterinary use.

Note: MF59® is a registered trademark of Novartis, and is used for comparative purposes only. AddaVax™ is not made by, affiliated with, sponsored by, or endorsed by Novartis. Novartis has not evaluated or approved the representations contained herein.

References:

1. Ott G. et al., 2000. The adjuvant MF59: a 10-year perspective. Methods in Molecular Medicine, Vol 42, 211-228.
2. Calabro, S. et al., 2013. The adjuvant effect of MF59 is due to the oil-in-water emulsion formulation, none of the individual components induce a comparable adjuvant effect. Vaccine 31:3363–9.
3. Ott G. et al., 1995. MF59. Design and evaluation of a safe and potent adjuvant for human vaccines. Pharm Biotechnol 6: 277-96.

Specifications

Specificity: Th1/Th2 response

VacciGrade™ (preclinical grade)

Working concentration: 1:1 (AddaVax™:antigen)

Quality control:

• Sterility guaranteed
• Endotoxin level < 1 EU/ml (measurement by kinetic chromogenic LAL assay)
• Particle size ~ 160 nm

Contents

• 10 ml AddaVax™ provided as a ready-to-use sterile emulsion.

AddaVax™ is shipped at room temperature.

Upon receipt, store at 4°C.

AddaVax™ is stable for 2 years from the date of manufacture (see certificate of analysis for further information).

DO NOT FREEZE.  Do not store AddaVax™ in plastic tubes.

VacciGrade™

VacciGrade™ is a high-quality pre-clinical grade. VacciGrade™ products are filter-sterilized (0.2 µm) and filled under strict aseptic conditions in a clean room*. The absence of bacterial contamination is assessed by a sterility test using a pharmacopeia-derived assay. The level of bacterial contaminants (endotoxins and lipoproteins) in each lot is verified using a LAL assay and/or a TLR2 and TLR4 reporter assay.
*Except for LPS VacciGrade™, which is prepared in a laminar flow hood dedicated to LPS.