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ISCOMATRIX® |
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Vaxjo ID |
87 |
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Vaccine Adjuvant Name |
ISCOMATRIX® |
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Adjuvant VO ID |
VO_0001333
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Description |
ISCOMATRIX is a particulate adjuvant comprising cholesterol, phospholipid and saponin but without antigen. The combination of an antigen with ISCOMATRIX is called an ISCOMATRIX vaccine. Antigens can be formulated with the ISCOMATRIX to produce ISCOMATRIX vaccines that can provide the similar antigen presentation and immunomodulatory properties as the ISCOMs but with much broader application as they are not limited to hydrophobic membrane proteins (Sun et al., 2009). ISCOMATRIX® adjuvant also demonstrates significant potential as a mucosal adjuvant, particularly for intranasal administration (Pearse and Drane, 2005). |
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Stage of Development |
Clinical Trial |
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Components |
Purified saponin fraction, cholesterol and phospholipid |
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Preparation |
The ISCOMATRIX® adjuvant forms spontaneously when saponin, cholesterol and phospholipid are mixed under controlled conditions. The manufacturing process is well defined and has been extensively optimised to produce a process that is robust, simple and amenable to production at large scale (Pearse and Drane, 2005). |
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Function |
ISCOMATRIX® vaccines are potent inducers of both humoral and cellular (CD4+ and CD8+ T-cell) immune responses (Pearse and Drane, 2005). |
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Safety |
The issue of reactogenicity with saponin-based adjuvants has been raised as a potential impediment to their widespread use in human and veterinary vaccines. This suggestion was largely based on mouse studies involving the administration of large adjuvant doses. However, in all other species tested including chickens, cats, monkeys, dogs, sheep, cattle and horses little reactogenicity has been observed with parenterally administered ISCOM® vaccines [12]. GLP toxicity studies have been performed on ISCOPREP™ saponin, ISCOMATRIX™ adjuvant and both ISCOM® and ISCOMATRIX® vaccines. In all cases, the formulations have been well tolerated with little evidence of reactogenicity following repeated dosing. To date, ISCOM® and ISCOMATRIX® vaccines have been administered to almost 1000 people without any vaccine-related serious adverse events or clinically significant biochemical or haematological abnormalities. The most common adverse event was pain/ache at the injection site, which was mild to moderate and transient in nature (2–3 days), resolving without the need for medical intervention (Pearse and Drane, 2005). |
| Related Vaccine(s) |
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| References |
Pearse and Drane, 2005: Pearse MJ, Drane D. ISCOMATRIX adjuvant for antigen delivery. Advanced drug delivery reviews. 2005; 57(3); 465-474. [PubMed: 15560952].
Sun et al., 2009: Sun HX, Xie Y, Ye YP. ISCOMs and ISCOMATRIX. Vaccine. 2009; 27(33); 4388-4401. [PubMed: 19450632].
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