AddaS03™ Adjuvant

Vaccine Adjuvant: Squalene emulsion

Composition and immune responses to AddaS03™

AddaS03™ is an oil-in-water nano-emulsion adjuvant, with a formulation similar to that of the adjuvant system AS03®, a fundamental component of pandemic influenza and protein-based covid vaccines [approved by relevant regulatory authorities] [1]. It is composed of the same percentage of two biodegradable oils, squalene and DL-α-tocopherol, and the surfactant, polysorbate 80 (Tween® 80), for increased stability. Squalene oil-in-water emulsions, such as MF59® or AS03®, allow for antigen dose sparing and result in mixed cell-mediated and humoral immune responses (Th1/Th2) [2-5]. A consistent signature pattern of early post-vaccine activation of myeloid and lymphoid cells following the administration of these adjuvants has emerged across multiple studies in humans [1].

AddaS03™ is VacciGrade™, a high-quality pre-clinical grade.

AddaS03™ is for research use only, and not for human or veterinary use.

Note: AS03® is a registered trademark of GSK, and is used for comparative purposes only. AddaS03™ is not made by, affiliated with, sponsored by, or endorsed by GSK. GSK has not evaluated or approved the representations contained herein.

 Read our review on Vaccine Adjuvants

​References:

1. O'Hagan, DT. et al. 2021. "World in motion" - emulsion adjuvants rising to meet the pandemic challenges. npj vaccines 6(1):158.
2. Morel, S. et al. 2011. Adjuvant System AS03 containing alpha-tocopherol modulates innate immune response and leads to improved adaptive immunity. Vaccine 29:2461.
3. 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.
4. Wilkins, AL et al., 2017. AS03- and MF59-Adjuvanted Influenza Vaccines in Children. Front Immunol 8:1760.
5. Shi, S. et al. 2019. Vaccine adjuvants: Understanding the structure and mechanism of adjuvanticity. Vaccine 37:3167.

Specifications

VacciGrade™ (preclinical grade)

Formulation: AddaS03™ is a nano-emulsion of DL-α-tocopherol (5% v/v) in squalene oil 5% (v/v) and Tween® 80 (1.8% v/v) in PBS (pH 6.8)

Note: The nano-emulsion is produced using a microfluidizer and filtered through a 0.22-µm filter to remove any large droplets and sterilize the final product. 

Quality control:

• Sterility guaranteed 
• Endotoxin level < 10 EU/ml (determined using the HEK-Blue™ LPS Detection Kit 2)
• AddaS03™ physio-chemical characteristics have been confirmed by sizing (determined by the dynamic light scattering method) and HPLC.

Contents

• 10 ml AddaS03™, provided as a ready-to-use sterile nano-emulsion

 AddaS03™ is shipped at room temperature.

 Upon receipt,  AddaS03™ should be stored at 4°C.

 DO NOT FREEZE.

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.