Montanide ISA 720 vaccines: quality control of emulsions, stability of formulated antigens, and comparative immunogenicity of vaccine formulations.

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

Vaccine

journal_title

Vaccine

authors

Miles AP,McClellan HA,Rausch KM,Zhu D,Whitmore MD,Singh S,Martin LB,Wu Y,Giersing BK,Stowers AW,Long CA,Saul A

doi

10.1016/j.vaccine.2004.08.049

subject

Has Abstract

pub_date

2005-03-31 00:00:00

pages

2530-9

issue

19

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(04)00709-1

journal_volume

23

pub_type

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