title: ISCOMATRIX() vaccines: Safety in human clinical studies.
abstract: ISCOMATRIX() adjuvant is a component of a variety of developmental vaccines. To evaluate the safety profile of ISCOMATRIX() adjuvant we have pooled and analyzed the safety data obtained from a number of vaccine development programs. Overall, the ISCOMATRIX() vaccines from studies included in the analysis were found to be safe and well tolerated, with no vaccine related deaths or Serious Adverse Events. A greater proportion of subjects who received ISCOMATRIX() vaccines experienced local and systemic reactogenicity compared with subjects who received placebo or active comparator, however this reactogenicity was generally mild, self-limiting and of short duration. Similar safety profiles were seen for each of these vaccines. To date, the ISCOMATRIX() vaccines have not been associated with events suggestive of autoimmune or allergic disorders. Specifically, analysis of the ISCOMATRIX() adjuvant adverse event database showed that there was no clustering of symptoms to suggest an allergic or autoimmune syndrome. Additionally, there were no reported autoimmune diagnoses and no events of anaphylaxis per se reported in any of the studies. Generally ISCOMATRIX() adjuvant did not adversely affect safety laboratory parameters and there was no clinically significant difference observed between studies or treatment groups. Studies using ISCOMATRIX() vaccines are ongoing and we continue to proactively analyze the safety of ISCOMATRIX() adjuvant.
authors.affiliation: CSL Limited, Parkville, VIC, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: McKenzie
authors.forename: Marli
authors.initials: M
authors.lastname: Watt
authors.forename: Charmaine
authors.initials: C
authors.lastname: Gittleson