Randomized, double-blind phase II trial of NY-ESO-1 ISCOMATRIX vaccine and ISCOMATRIX adjuvant alone in patients with resected stage IIc, III, or IV malignant melanoma.

Cebon, Jonathan; McArthur, Grant A.; Chen, W; Davis, Ian D.; Gore, M.; Thompson, John F.; Millward, Michael; Mpn., Findlay; Dunbar, P. Rod; Chh., Ottensmeier; Venhaus, Ralph; Nathan, Paul; Dalgleish, Angus; Cerundolo, Vincenzo; Maraskovsky, Eugene; Hopkins, Wendie; Marsden, J.R.; Smithers, B. Mark; Hersey, Peter; Trj., Evans

doi:10.1200/jco.2014.32.15_suppl.9050

Cited by 5 publications

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“…An alternative form of ISCOM is ISCOMATRIX, which is formulated without antigen [136]. ISCOMATRIX adjuvant has been used for both prophylactic and therapeutic vaccines in clinical trials [137,138]. ISCOMATRIX adjuvant has been used for both prophylactic and therapeutic vaccines in clinical trials [137,138].…”

Section: Immunostimulating Complexesmentioning

confidence: 99%

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Novel approaches for the design, delivery and administration of vaccine technologies

Wallis

Shenton

Carlisle

2019

Clinical and Experimental Immunology

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Summary It is easy to argue that vaccine development represents humankind’s most important and successful endeavour, such is the impact that vaccination has had on human morbidity and mortality over the last 200 years. During this time the original method of Jenner and Pasteur, i.e. that of injecting live‐attenuated or inactivated pathogens, has been developed and supplemented with a wide range of alternative approaches which are now in clinical use or under development. These next‐generation technologies have been designed to produce a vaccine that has the effectiveness of the original live‐attenuated and inactivated vaccines, but without the associated risks and limitations. Indeed, the method of development has undoubtedly moved away from Pasteur’s three Is paradigm (isolate, inactivate, inject) towards an approach of rational design, made possible by improved knowledge of the pathogen–host interaction and the mechanisms of the immune system. These novel vaccines have explored methods for targeted delivery of antigenic material, as well as for the control of release profiles, so that dosing regimens can be matched to the time‐lines of immune system stimulation and the realities of health‐care delivery in dispersed populations. The methods by which vaccines are administered are also the subject of intense research in the hope that needle and syringe dosing, with all its associated issues regarding risk of injury, cross‐infection and patient compliance, can be replaced. This review provides a detailed overview of new vaccine vectors as well as information pertaining to the novel delivery platforms under development.

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Section: Immunostimulating Complexesmentioning

confidence: 99%

“…This approach allows for a more flexible application, as almost any antigen can potentially be mixed with the ISCOMATRIX adjuvant. ISCOMATRIX adjuvant has been used for both prophylactic and therapeutic vaccines in clinical trials [137,138].…”

Section: Immunostimulating Complexesmentioning

confidence: 99%

Novel approaches for the design, delivery and administration of vaccine technologies

Wallis

Shenton

Carlisle

2019

Clinical and Experimental Immunology

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“…Vaccines adjuvanted with either ISCOMATRIX or Matrix-M ™ have been shown to induce strong antibody and T-cell responses and to be well tolerated in both pre-clinical and clinical studies [ 24 , 25 ]. ISCOMATRIX is currently under evaluation in candidate vaccines against hepatitis C virus (HCV) [ 26 ], influenza [ 27 ] and cancer [ 28 – 30 ]. Matrix-M ™ is currently being investigated in vaccines for influenza, HSV type 2 and malaria [ 23 , 31 ].…”

Section: Introductionmentioning

confidence: 99%

Meta-Analysis on Randomized Controlled Trials of Vaccines with QS-21 or ISCOMATRIX Adjuvant: Safety and Tolerability

2016

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Background and ObjectivesQS-21 shows in vitro hemolytic effect and causes side effects in vivo. New saponin adjuvant formulations with better toxicity profiles are needed. This study aims to evaluate the safety and tolerability of QS-21 and the improved saponin adjuvants (ISCOM, ISCOMATRIX and Matrix-M™) from vaccine trials.MethodsA systematic literature search was conducted from MEDLINE, EMBASE, Cochrane library and Clinicaltrials.gov. We selected for the meta-analysis randomized controlled trials (RCTs) of vaccines adjuvanted with QS-21, ISCOM, ISCOMATRIX or Matrix-M™, which included a placebo control group and reported safety outcomes. Pooled risk ratios (RRs) and their 95% confidence intervals (CIs) were calculated using a random-effects model. Jadad scale was used to assess the study quality.ResultsNine RCTs were eligible for the meta-analysis: six trials on QS-21-adjuvanted vaccines and three trials on ISCOMATRIX-adjuvanted, with 907 patients in total. There were no studies on ISCOM or Matrix-M™ adjuvanted vaccines matching the inclusion criteria. Meta-analysis identified an increased risk for diarrhea in patients receiving QS21-adjuvanted vaccines (RR 2.55, 95% CI 1.04–6.24). No increase in the incidence of the reported systemic AEs was observed for ISCOMATRIX-adjuvanted vaccines. QS-21- and ISCOMATRIX-adjuvanted vaccines caused a significantly higher incidence of injection site pain (RR 4.11, 95% CI 1.10–15.35 and RR 2.55, 95% CI 1.41–4.59, respectively). ISCOMATRIX-adjuvanted vaccines also increased the incidence of injection site swelling (RR 3.43, 95% CI 1.08–10.97).ConclusionsOur findings suggest that vaccines adjuvanted with either QS-21 or ISCOMATRIX posed no specific safety concern. Furthermore, our results indicate that the use of ISCOMATRIX enables a better systemic tolerability profile when compared to the use of QS-21. However, no better local tolerance was observed for ISCOMATRIX-adjuvanted vaccines in immunized non-healthy subjects. This meta-analysis is limited by the relatively small number of individuals recruited in the included trials, especially in the control groups.

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Immunomodulatory Nanosystems

et al. 2019

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Immunotherapy has emerged as an effective strategy for the prevention and treatment of a variety of diseases, including cancer, infectious diseases, inflammatory diseases, and autoimmune diseases. Immunomodulatory nanosystems can readily improve the therapeutic effects and simultaneously overcome many obstacles facing the treatment method, such as inadequate immune stimulation, off‐target side effects, and bioactivity loss of immune agents during circulation. In recent years, researchers have continuously developed nanomaterials with new structures, properties, and functions. This Review provides the most recent advances of nanotechnology for immunostimulation and immunosuppression. In cancer immunotherapy, nanosystems play an essential role in immune cell activation and tumor microenvironment modulation, as well as combination with other antitumor approaches. In infectious diseases, many encouraging outcomes from using nanomaterial vaccines against viral and bacterial infections have been reported. In addition, nanoparticles also potentiate the effects of immunosuppressive immune cells for the treatment of inflammatory and autoimmune diseases. Finally, the challenges and prospects of applying nanotechnology to modulate immunotherapy are discussed.

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Randomized, double-blind phase II trial of NY-ESO-1 ISCOMATRIX vaccine and ISCOMATRIX adjuvant alone in patients with resected stage IIc, III, or IV malignant melanoma.

Cited by 5 publications

References 0 publications

Novel approaches for the design, delivery and administration of vaccine technologies

Novel approaches for the design, delivery and administration of vaccine technologies

Meta-Analysis on Randomized Controlled Trials of Vaccines with QS-21 or ISCOMATRIX Adjuvant: Safety and Tolerability

Immunomodulatory Nanosystems

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