Safety data of Montanide ISA 51 VG and Montanide ISA 720 VG, two adjuvants dedicated to human therapeutic vaccines

Ascarateil, Stephane; Puget, Aude; Koziol, Marie-Eve

doi:10.1186/2051-1426-3-s2-p428

Cited by 30 publications

(24 citation statements)

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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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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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“…Fifteen HLA-A2 positive patients with biopsy verified stage III–IV NSCLC in stable disease after standard chemotherapy were treated with subcutaneous vaccinations (100 μg IDO5 peptide, sequence ALLEIASCL, formulated in 900 μl of the adjuvant Montanide) ( 11 ). This study was carried out in accordance with the recommendations of GCP with written informed consent from all subjects.…”

Section: Methodsmentioning

confidence: 99%

Durable Clinical Responses and Long-Term Follow-Up of Stage III–IV Non-Small-Cell Lung Cancer (NSCLC) Patients Treated With IDO Peptide Vaccine in a Phase I Study—A Brief Research Report

et al. 2018

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Background: Long-term follow-up on a clinical trial of 15 stage III-IV NSCLC patients treated with an Indoleamine 2,3-Dioxygenase (IDO) peptide vaccine (NCT01219348).Methods: Fifteen HLA-A2-positive patients with stable stage III-IV NSCLC after standard chemotherapy were treated with subcutaneous vaccinations (100 μg IDO5 peptide, sequence ALLEIASCL, formulated in 900 μl Montanide) biweekly for 2.5 months and thereafter monthly until progression or up to 5 years. Here we report long-term clinical follow-up, toxicity and immunity.Results: Three of 15 patients are still alive corresponding to a 6-year overall survival of 20 %. Two patients continued monthly vaccinations for 5 years (56 vaccines). One of the two patients developed a partial response (PR) of target lesions in the liver 15 months after the first vaccine and has remained in PR ever since. The other patient had a solitary distant metastasis in a lymph node in retroperitoneum at baseline which normalized during treatment. All following evaluation scans during the treatment have been tumor free. The vaccine was well tolerated for all 5 years with no long-term toxicities registered. The third long-term surviving patient discontinued vaccinations after 11 months due to disease progression. Flow cytometry analyses of PBMCs from the two long-term responders demonstrated stable CD8+ and CD4+ T-cell populations during treatment. In addition, presence of IDO-specific T-cells was detected by IFN-γ Elispot in both patients at several time points during treatment.Conclusion: IDO peptide vaccination was well tolerated for administration up to 5years. Two of 15 patients are long-term responders with ongoing clinical response 6 years after 1st vaccination.

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“…The use of an emulsion as a delivery system has been of specific interest in adjuvant research for a long time. Some emulsion adjuvants available in the market and undergoing clinical trials include oil-in-water (O/W) emulsions MF59 [23] (Novartis, Basel, Switzerland), AS02 and AS03 [24] (GSK), AF03 [25] (Sanofi Pasteur, Lyon, France), SE, MPL-SE, GLA-SE, and SLA-SE (Infectious Disease Research Institute, Seattle, WA, USA) [26][27][28][29], and water-in-oil (W/O) emulsions Montanide ISA720 and Montanide ISA51 [30][31][32] (Seppic's Montanide).…”

Section: Emulsion Adjuvantsmentioning

confidence: 99%

Better Adjuvants for Better Vaccines: Progress in Adjuvant Delivery Systems, Modifications, and Adjuvant–Antigen Codelivery

Wang

2020

Vaccines

113

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Traditional aluminum adjuvants can trigger strong humoral immunity but weak cellular immunity, limiting their application in some vaccines. Currently, various immunomodulators and delivery carriers are used as adjuvants, and the mechanisms of action of some of these adjuvants are clear. However, customizing targets of adjuvant action (cellular or humoral immunity) and action intensity (enhancement or inhibition) according to different antigens selected is time-consuming. Here, we review the adjuvant effects of some delivery systems and immune stimulants. In addition, to improve the safety, effectiveness, and accessibility of adjuvants, new trends in adjuvant development and their modification strategies are discussed.

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Safety data of Montanide ISA 51 VG and Montanide ISA 720 VG, two adjuvants dedicated to human therapeutic vaccines

Cited by 30 publications

References 0 publications

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

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

Durable Clinical Responses and Long-Term Follow-Up of Stage III–IV Non-Small-Cell Lung Cancer (NSCLC) Patients Treated With IDO Peptide Vaccine in a Phase I Study—A Brief Research Report

Better Adjuvants for Better Vaccines: Progress in Adjuvant Delivery Systems, Modifications, and Adjuvant–Antigen Codelivery

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