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Montanide ISA 51

Vaxjo ID 31
Vaccine Adjuvant Name Montanide ISA 51
Alternative Names Purified IFA
Adjuvant VO ID VO_0001270
Description Montanide ISA 51 has been used as an experimental adjuvant for protein and peptide vaccines (Wu et al., 2008).
Stage of Development Clinical Trial
Components Like Freund’s Incomplete Adjuvant (FIA), it is based on mineral oil with a mannide monooleate emulsifier (Wu et al., 2008).
Structure Mannide oleate (mostly mannide monooleate, esters of mannitol and oleic acids -an example shown below) (MONTANIDE 80) in mineral oil solution (DRAKEOL 6VR) (Vogel and Powell, 1995).
Appearance Limpid clear yellow liquid (Vogel and Powell, 1995).
Storage Store at 4° C or room temperature under nitrogen. Stable at room temperature for at least 1 year. Store at physiological pH (Vogel and Powell, 1995).
Function In contrast to FIA, a highly purified emulsifier is used in Montanide ISA51, thus avoiding impurities that contributed to the toxicity of some batches of FIA. It also uses a different ratio of emulsifier to oil, resulting in a more consistent and controllable emulsion (Wu et al., 2008).
Safety Experience in human trials indicated that Montanide ISA 51 was an effective immune enhancer and was generally well tolerated. Most reported adverse reactions were transient local reactions, including local swelling and pain with or without fever. In these studies, mild injection site nodules were reported that resolved within weeks without medical intervention (Wu et al., 2008).
Related Vaccine(s)
References
Vogel and Powell, 1995: Vogel FR, Powell MF. A compendium of vaccine adjuvants and excipients. Pharmaceutical biotechnology. 1995; 6; 141-228. [PubMed: 7551218].
Wu et al., 2008: Wu Y, Ellis RD, Shaffer D, Fontes E, Malkin EM, Mahanty S, Fay MP, Narum D, Rausch K, Miles AP, Aebig J, Orcutt A, Muratova O, Song G, Lambert L, Zhu D, Miura K, Long C, Saul A, Miller LH, Durbin AP. Phase 1 trial of malaria transmission blocking vaccine candidates Pfs25 and Pvs25 formulated with montanide ISA 51. PloS one. 2008; 3(7); e2636. [PubMed: 18612426].