SynthesisHuman vaccines & immunotherapeutics2016
Safety and tolerability evaluation of the use of Montanide ISA™51 as vaccine adjuvant: A systematic review.
Synthesis in Human vaccines & immunotherapeutics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 77 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
77 citing papers in PubMed, 1 synthesis or guideline pooled it, 126 citations in OpenAlex.
- Immunosenescence: A systems-level overview of immune cell biology and strategies for improving vaccine responses.Experimental gerontology · 2019Pooled it
- Phase I/II trial of a peptide-based COVID-19 T-cell activator in patients with B-cell deficiency.Nature communications · 2023Trial
- Phase IIa Study of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Trial
- Randomized clinical trial to assess the protective efficacy of a Plasmodium vivax CS synthetic vaccine.Nature communications · 2022Trial
- Vaccination against RhoC induces long-lasting immune responses in patients with prostate cancer: results from a phase I/II clinical trial.Journal for immunotherapy of cancer · 2020Trial
- Phase 2 trial of a multivalent WT1 peptide vaccine (galinpepimut-S) in acute myeloid leukemia.Blood advances · 2018Trial
- 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.BMC infectious diseases · 2017Trial
- A data-driven cartography of NSCLC vaccine research: Quantifying the paradigm shift toward immuno-oncology combination therapies.Human vaccines & immunotherapeutics · 2026Review
- Therapeutic vaccines targeting solid tumors: A series of clinical trial analysis over the past decade.Translational oncology · 2026Review
- Vaccination with cationic liposome-encapsulated CD4 and CD8 T cell neoepitopes induces superior tumor control.Materials today. Bio · 2026Article
- Assessment of the Immune Potential of Calcium Phosphate-Outer Membrane Protein-Nanoparticles (CaP-Omp-Nps) Adjuvanted Nano-Vaccine AgainstPharmaceutics · 2026Article
- Designer Solid Self-Emulsifying Nanovaccines Enable Dual Modulation of Dendritic Cells and T Cells for Potent Antitumor Immunity.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Efficacy of Immunostimulatory Adjuvants and Nano-Adjuvants in Current SARS-CoV-2 Vaccines: A Comprehensive Review.Health science reports · 2025Article
- Construction and Immune Strategy Optimization of a Vaccine Strain for Influenza A (H5N8) Subtype.Viruses · 2025Article
- MDSC depletion during immunization with heat-killedFrontiers in immunology · 2025Article
- REGAL: galinpepimut-S vs. best available therapy as maintenance therapy for acute myeloid leukemia in second remission.Future oncology (London, England) · 2025Article
- Vaccine therapies for glioma: clinical frontiers and potential breakthrough.Frontiers in oncology · 2025Review
- Enhancing vaccine effectiveness in the elderly to counter antibiotic resistance: The potential of adjuvants via pattern recognition receptors.Human vaccines & immunotherapeutics · 2024Review
- Vaccine adjuvants for infectious disease in the clinic.Bioengineering & translational medicine · 2024Review
- Safety and efficacy of C. muridarum vaccines adjuvanted with CpG-1826 and four concentrations of Montanide-ISA-720-VG.NPJ vaccines · 2024Article
17 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.