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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Hum+Vaccin+Immunother
2016 ; 12
(1
): 159-69
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Safety and tolerability evaluation of the use of Montanide ISA?51 as vaccine
adjuvant: A systematic review
#MMPMID26378866
van Doorn E
; Liu H
; Huckriede A
; Hak E
Hum Vaccin Immunother
2016[]; 12
(1
): 159-69
PMID26378866
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Montanide ISA?51 (ISA 51) is a vaccine adjuvant which has been tested in
therapeutic and prophylactic vaccine trials. The aim of this review is to present
a comprehensive examination of the safety and tolerability of ISA 51 containing
vaccines. A systematic literature search was conducted in PubMed, EMBASE and
clinicaltrials.gov . Eligible studies were categorized into: (A) uncontrolled
studies with non-healthy subjects, (B) controlled studies with non-healthy
subjects, and (C) controlled studies with healthy subjects. Reported adverse
events (AEs) were assessed. 91 studies were included in our review. Generally
observed AEs included injection site reaction; injection site pain; myalgia;
headache; gastro-intestinal disorders; fatigue and fever - regardless of the
administration route and subject characteristic. Specific AEs, e.g. injection
site reactions and rash, were more frequently reported from subjects receiving
ISA 51-adjuvanted vaccines than from subjects receiving antigen or ISA 51 only.
The reported AEs were mainly mild to moderate in intensity. Serious AEs (SAEs)
were reported in 27% of the uncontrolled trials and 2 trials conducted with
healthy subjects. Notably, 2 other trials conducted with healthy subjects were
stopped due to unacceptable AEs. Some studies indicate that the mixing procedure
of antigen and adjuvant might influence the occurrence of AEs. Reports on SAEs
and premature termination of 2 trials advise caution when using ISA 51. Yet, AEs
might be preventable by proper mixing of vaccine and adjuvant to a stable
emulsion. Trials including an active control group are needed for a fair
evaluation of adjuvant safety.
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