Abstract:
:Montanide ISA 720 is an experimental adjuvant, formulated as water-in-oil emulsions, that induces high antibody titers in several animal species. It has been used in human vaccine trials with malaria and HIV vaccines. The heightened response is likely due, in part, to the formation of a depot at the injection site. However, post-formulation modifications were seen with seven proteins tested during storage of ISA 720 formulations at 37 degrees C for 1 week and two proteins stored longer at 4 degrees C. Potency studies in mice, in which the stored vaccines were diluted into placebo emulsions for appropriate dosing, indicated that this instability could lead to loss of immunogenicity in the post-injection depot, limiting the allowable storage time of preformed vaccines. We describe point-of-injection formulation for ISA 720 vaccines that meets the requirement for in vitro stability. For preformed vaccines, addition of glycine or glycylglycine prevented antigen modification on storage at 37 degrees C, providing a potential way of stabilizing antigen/ISA 720 formulations for in vitro storage and the post-injection depot.
journal_name
Vaccinejournal_title
Vaccineauthors
Miles AP,McClellan HA,Rausch KM,Zhu D,Whitmore MD,Singh S,Martin LB,Wu Y,Giersing BK,Stowers AW,Long CA,Saul Adoi
10.1016/j.vaccine.2004.08.049subject
Has Abstractpub_date
2005-03-31 00:00:00pages
2530-9issue
19eissn
0264-410Xissn
1873-2518pii
S0264-410X(04)00709-1journal_volume
23pub_type
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