PMID- 26378866
OWN - NLM
STAT- MEDLINE
DCOM- 20161213
LR  - 20181202
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 12
IP  - 1
DP  - 2016
TI  - Safety and tolerability evaluation of the use of Montanide ISA51 as vaccine 
      adjuvant: A systematic review.
PG  - 159-69
LID - 10.1080/21645515.2015.1071455 [doi]
AB  - Montanide ISA51 (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.
FAU - van Doorn, Eva
AU  - van Doorn E
AD  - a Unit of PharmacoEpidemiology and PharmacoEconomics (PE2); Department of 
      Pharmacy; University of Groningen ; Groningen , The Netherlands.
FAU - Liu, Heng
AU  - Liu H
AD  - a Unit of PharmacoEpidemiology and PharmacoEconomics (PE2); Department of 
      Pharmacy; University of Groningen ; Groningen , The Netherlands.
FAU - Huckriede, Anke
AU  - Huckriede A
AD  - b Department of Medical Microbiology ; University of Groningen; University 
      Medical Center of Groningen ; Groningen , The Netherlands.
FAU - Hak, Eelko
AU  - Hak E
AD  - a Unit of PharmacoEpidemiology and PharmacoEconomics (PE2); Department of 
      Pharmacy; University of Groningen ; Groningen , The Netherlands.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PT  - Systematic Review
DEP - 20150917
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Adjuvants, Immunologic)
RN  - 0 (Oleic Acids)
RN  - 0 (Vaccines)
RN  - 0 (montanide ISA 51)
RN  - 3OWL53L36A (Mannitol)
SB  - IM
MH  - Adjuvants, Immunologic/*administration & dosage/*adverse effects
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/*pathology
MH  - Fatigue/chemically induced
MH  - Fever/chemically induced
MH  - Gastrointestinal Diseases/chemically induced
MH  - Headache/chemically induced
MH  - Humans
MH  - Mannitol/administration & dosage/adverse effects/*analogs & derivatives
MH  - Oleic Acids/*administration & dosage/*adverse effects
MH  - Pain/chemically induced
MH  - Skin Diseases/chemically induced/pathology
MH  - Vaccines/administration & dosage
PMC - PMC4962750
OTO - NOTNLM
OT  - ISA 51
OT  - Montanide
OT  - adverse event
OT  - safety
OT  - systematic review
OT  - tolerability
EDAT- 2015/09/18 06:00
MHDA- 2016/12/15 06:00
PMCR- 2016/09/17
CRDT- 2015/09/18 06:00
PHST- 2015/09/18 06:00 [entrez]
PHST- 2015/09/18 06:00 [pubmed]
PHST- 2016/12/15 06:00 [medline]
PHST- 2016/09/17 00:00 [pmc-release]
AID - 1071455 [pii]
AID - 10.1080/21645515.2015.1071455 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2016;12(1):159-69. doi: 10.1080/21645515.2015.1071455. 
      Epub 2015 Sep 17.