Safety and tolerability evaluation of the use of Montanide ISA™51 as vaccine adjuvant: A systematic review

Doorn, Eva van; Liu, Heng; Huckriede, Anke; Hak, Eelko

doi:10.1080/21645515.2015.1071455

Cited by 108 publications

(95 citation statements)

References 44 publications

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“…To determine whether the ability to induce polarized Tfh responses is shared by these adjuvants, we tested two of them, Montanide ISA 51 VG™ (ISA51) and Montanide ISA 720 VG™ (ISA720), which have been both used in numerous clinical trials related to therapeutic vaccines (14, 15). Montanide ISA 51 VG™, similar to IFA, contains a non-metabolizable mineral oil as its main component whereas Montanide ISA 720 VG™ incorporates squalene as a metabolizable oil.…”

Section: Resultsmentioning

confidence: 99%

Water-in-Oil–Only Adjuvants Selectively Promote T Follicular Helper Cell Polarization through a Type I IFN and IL-6–Dependent Pathway

Riteau

Radtke

Shenderov

et al. 2016

The Journal of Immunology

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T follicular helper (Tfh) cells are a subset of CD4+ T lymphocytes that promote the development of humoral immunity. While the triggers required for the differentiation of the other major T helper subsets are well defined, those responsible for Tfh responses are still poorly understood. We determined that mice immunized with either peptide or protein antigens emulsified in incomplete Freund’s adjuvant or related water-in-oil adjuvants develop a highly polarized response in which the majority of the antigen-specific CD4+ T cells are germinal center-homing CXCR5+Bcl6+ Tfh. Despite the absence of exogenous microbial PAMPs, the Tfh responses observed were partially MyD88 dependent. Importantly, in addition to IL-6, T cell intrinsic type I IFN signaling is also required for optimal Tfh polarization. These findings suggest that water-in-oil adjuvants promote Tfh dominated responses by triggering endogenous alarm signals that in turn induce type I IFN-dependent differentiation pathway functioning in T cells.

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Section: Resultsmentioning

confidence: 99%

Water-in-Oil–Only Adjuvants Selectively Promote T Follicular Helper Cell Polarization through a Type I IFN and IL-6–Dependent Pathway

Riteau

Radtke

Shenderov

et al. 2016

The Journal of Immunology

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“…The montanide adjuvant is a known irritant, 26 and many of the most frequent toxicities consisted of mild to moderate local reactions and inflammation: injection site reaction (46%), fatigue (32%), skin induration (32%), and injection site pruritus (27%). These toxicities were self-limited and responded to local supportive measures and analgesics.…”

Section: Safety and Toxicitymentioning

confidence: 99%

Phase 2 trial of a multivalent WT1 peptide vaccine (galinpepimut-S) in acute myeloid leukemia

et al. 2018

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“…Montanide ISA-51 has been used in thousands of subjects in clinical trials. Reported adverse events were mainly mild to moderate in intensity and include pain or a reaction at the injection site, headache and myalgia [28, 29]. Montanide ISA-51 creates a water-in-oil emulsion previously shown to enhances the cellular immune responses when added to FLU-v [13, 24].…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the immunogenicity and safety of different doses and formulations of a broad spectrum influenza vaccine (FLU-v) developed by SEEK: study protocol for a single-center, randomized, double-blind and placebo-controlled clinical phase IIb trial

et al. 2017

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BackgroundCurrent influenza vaccines, based on antibodies against surface antigens, are unable to provide protection against newly emerging virus strains which differ from the vaccine strains. Therefore the population has to be re-vaccinated annually. It is thus important to develop vaccines which induce protective immunity to a broad spectrum of influenza viruses. This trial is designed to evaluate the immunogenicity and safety of FLU-v, a vaccine composed of four synthetic peptides with conserved epitopes from influenza A and B strains expected to elicit both cell mediated immunity (CMI) and humoral immunity providing protection against a broad spectrum of influenza viruses.MethodsIn a single-center, randomized, double-blind and placebo-controlled phase IIb trial, 222 healthy volunteers aged 18–60 years will be randomized (2:2:1:1) to receive two injections of a suspension of 500 μg FLU-v in saline (arm 1), one dose of emulsified 500 μg FLU-v in Montanide ISA-51 and water for injection (WFI) followed by one saline dose (arm 2), two saline doses (arm 3), or one dose of Montanide ISA-51 and WFI emulsion followed by one saline dose (arm 4). All injections will be given subcutaneously. Primary endpoints are safety and FLU-v induced CMI, evaluated by cytokine production by antigen specific T cell populations (flow-cytometry and ELISA). Secondary outcomes are measurements of antibody responses (ELISA and multiplex), whereas exploratory outcomes include clinical efficacy and additional CMI assays (ELISpot) to show cross-reactivity.DiscussionBroadly protective influenza vaccines able to provide protection against multiple strains of influenza are urgently needed. FLU-v is a promising vaccine which has shown to trigger the cell-mediated immune response. The dosages and formulations tested in this current trial are also estimated to induce antibody response. Therefore, both cellular and humoral immune responses will be evaluated.Trial registrationEudraCT number 2015–001932-38; retrospectively registered clinicaltrials.gov NCT02962908 (November 7th 2016).

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Safety and tolerability evaluation of the use of Montanide ISA™51 as vaccine adjuvant: A systematic review

Cited by 108 publications

References 44 publications

Water-in-Oil–Only Adjuvants Selectively Promote T Follicular Helper Cell Polarization through a Type I IFN and IL-6–Dependent Pathway

Water-in-Oil–Only Adjuvants Selectively Promote T Follicular Helper Cell Polarization through a Type I IFN and IL-6–Dependent Pathway

Phase 2 trial of a multivalent WT1 peptide vaccine (galinpepimut-S) in acute myeloid leukemia

Evaluation of the immunogenicity and safety of different doses and formulations of a broad spectrum influenza vaccine (FLU-v) developed by SEEK: study protocol for a single-center, randomized, double-blind and placebo-controlled clinical phase IIb trial

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