Evidence map›Paper›PMID 26581199›Full record

Trial reportCancer immunology, immunotherapy : CII2016

A randomized pilot trial testing the safety and immunologic effects of a MAGE-A3 protein plus AS15 immunostimulant administered into muscle or into dermal/subcutaneous sites.

Craig L Slingluff, Gina R Petroni, Walter C Olson, Mark E Smolkin, Kimberly A Chianese-Bullock, Ileana S Mauldin, Kelly T Smith, Donna H Deacon, Nikole E Varhegyi, Sean B Donnelly and 4 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01425749 (T Cell Activation and Immune Cell Function in Melanoma Patients Treated With recMAGE-A3 + AS15 Immunological Adjuvant System), which is not on this map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
1.7field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT01425749 early_phase1completednot on this map

T Cell Activation and Immune Cell Function in Melanoma Patients Treated With recMAGE-A3 + AS15 Immunological Adjuvant System

TypeinterventionalSponsorCraig L Slingluff, JrRan2011 to 2015Enrolled25ConditionsMelanomaArmsrecMAGE-A3 + AS15 ASCI
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 37 citations in OpenAlex.

  1. Trial
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  3. Statistical controversies in clinical research: early-phase adaptive design for combination immunotherapies.Annals of oncology : official journal of the European Society for Medical Oncology · 2017
    Trial
  4. Trial
  5. Review
  6. TLR9: A Double-Dealing Toll-Like Receptor.ImmunoTargets and therapy · 2025
    Review
  7. Review
  8. Article
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  19. Immunomodulatory Nanosystems.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2019
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 1 institution in 1 country.

Craig L SlingluffDivision of Surgical Oncology, Department of Surgery, Human Immune Therapy Center, Cancer Center, University of Virginia, 1352 Jordan Hall, P.O. Box 801457, Charlottesville, VA, 22908, USA. cls8h@virginia.edu.
Gina R PetroniDepartment of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.
Walter C OlsonDivision of Surgical Oncology, Department of Surgery, Human Immune Therapy Center, Cancer Center, University of Virginia, 1352 Jordan Hall, P.O. Box 801457, Charlottesville, VA, 22908, USA.
Mark E SmolkinDepartment of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.
Kimberly A Chianese-BullockDivision of Surgical Oncology, Department of Surgery, Human Immune Therapy Center, Cancer Center, University of Virginia, 1352 Jordan Hall, P.O. Box 801457, Charlottesville, VA, 22908, USA.
Ileana S MauldinDivision of Surgical Oncology, Department of Surgery, Human Immune Therapy Center, Cancer Center, University of Virginia, 1352 Jordan Hall, P.O. Box 801457, Charlottesville, VA, 22908, USA.
Kelly T SmithDivision of Surgical Oncology, Department of Surgery, Human Immune Therapy Center, Cancer Center, University of Virginia, 1352 Jordan Hall, P.O. Box 801457, Charlottesville, VA, 22908, USA.
Donna H DeaconDivision of Surgical Oncology, Department of Surgery, Human Immune Therapy Center, Cancer Center, University of Virginia, 1352 Jordan Hall, P.O. Box 801457, Charlottesville, VA, 22908, USA.
Nikole E VarhegyiDepartment of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.
Sean B DonnellyDivision of Surgical Oncology, Department of Surgery, Human Immune Therapy Center, Cancer Center, University of Virginia, 1352 Jordan Hall, P.O. Box 801457, Charlottesville, VA, 22908, USA.
Caroline M ReedDivision of Surgical Oncology, Department of Surgery, Human Immune Therapy Center, Cancer Center, University of Virginia, 1352 Jordan Hall, P.O. Box 801457, Charlottesville, VA, 22908, USA.
Kristy ScottDivision of Surgical Oncology, Department of Surgery, Human Immune Therapy Center, Cancer Center, University of Virginia, 1352 Jordan Hall, P.O. Box 801457, Charlottesville, VA, 22908, USA.
Nadejda V GaleassiDivision of Surgical Oncology, Department of Surgery, Human Immune Therapy Center, Cancer Center, University of Virginia, 1352 Jordan Hall, P.O. Box 801457, Charlottesville, VA, 22908, USA.
William W GroshDivision of Hematology-Oncology, Department of Medicine, University of Virginia, Charlottesville, VA, USA.
University of Virginia · US

Funding

Women's Oncology Program - WONP30CA044579 · NCI · UNIVERSITY OF VIRGINIA CHARLOTTESVILLE · PI Thomas P. Loughran · 1987 to 2026
$72.1M
Cancer Research Training Program: From Molecular Mechanisms to Therapeutic StrategiesT32CA009109 · NCI · UNIVERSITY OF VIRGINIA CHARLOTTESVILLE · PI Andrew Carl Dudley, Melanie R Rutkowski · 1985 to 2026
$13.9M
NCI NIH HHS P30 CA044579NCI NIH HHS P30 CA44579NCI NIH HHS T32 CA009109
6 · The paper itself

Abstract

introductionMethods to induce T cell responses to protein vaccines have not been optimized. The immunostimulant AS15 has been administered with the recombinant MAGE-A3 protein (recMAGE-A3) i.m. but not i.d. or s.c. This study tests hypotheses that the i.d./s.c. route is safe and will increase CD4(+) and CD8(+) T cell responses to MAGE-A3. PATIENTS AND

methodsTwenty-five patients with resected stage IIB-IV MAGE-A3(+) melanoma were randomized to immunization with recMAGE-A3 combined with AS15 immunostimulant (MAGE-A3 immunotherapeutic) either i.m. (group A, n = 13) or i.d./s.c. (group B, n = 12). Adverse events were recorded. Ab responses to MAGE-A3 were measured by ELISA. T cell responses to overlapping MAGE-A3 peptides were assessed in PBMC and a sentinel immunized node (SIN) after 1 in vitro stimulation with recMAGE-A3, by IFN-γ ELISPOT assay and by flow cytometry for multifunctional (TNF-α/IFN-γ) responses.

resultsBoth routes of immunization were well tolerated without treatment-related grade 3 adverse events. All patients had durable Ab responses. For all 25 patients, the T cell response rate by ELISPOT assay was 30 % in SIN (7/23) but only 4 % (1/25) in PBMC. By flow cytometry, multifunctional CD8(+) T cell responses were identified in one patient in each group; multifunctional CD4(+) T cell response rates for groups A and B, respectively, were 31 and 64 % in SIN and 31 and 50 % in PBMC.

conclusionThe MAGE-A3 immunotherapeutic was well tolerated after i.d./s.c. administration, with trends to higher CD4(+) T cell response rates than with i.m. administration. This study supports further study of AS15 by i.d./s.c. administration.

Indexed as

Adjuvants, ImmunologicAdultAgedAged, 80 and overAntigens, NeoplasmCancer VaccinesHumansInjections, IntramuscularMiddle AgedNeoplasm ProteinsPilot ProjectsTreatment OutcomeAdjuvants, ImmunologicAntigens, NeoplasmCancer VaccinesNeoplasm ProteinsCancer vaccinesHumanMelanoma/imTLR agonistsT lymphocytesVaccine adjuvants

Identifiers

PMID26581199
PMCPMC5010424
OpenAlexW2177794153

What OpenQuestion holds

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LicenceTDM
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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.