Evidence map›Paper›PMID 42082270›Full record

ArticleJournal for immunotherapy of cancer2026

Safety and immunogenicity of a tri-antigen vaccine targeting IGFBP-2, HER2, and IGF-IR in participants with non-metastatic breast cancer.

Sasha E Stanton, Denise L Cecil, Howard H Bailey, Ying Liu, William R Gwin, Andrew L Colveler, John B Liao, Kari B Wisinski, Lisa Barroilhet, KyungMann Kim and 8 more

Registry-linked trialAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal for immunotherapy of cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02780401 (A Phase I Trial of the Safety and Immunogenicity of a DNA Plasmid Based Vaccine), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

NCT02780401 phase1completednot on this map

A Phase I Trial of the Safety and Immunogenicity of a DNA Plasmid Based Vaccine (WOKVAC) Encoding Epitopes Derived From Three Breast Cancer Antigens (IGFBP-2, HER2, and IGF-1R) in Patients With Breast Cancer

TypeinterventionalSponsorUniversity of WashingtonRan2016 to 2022Enrolled32ConditionsHER2/Neu Negative, No Evidence of Disease, One or More Positive Axillary Nodes, Stage IB Breast CancerArmsLaboratory Biomarker Analysis, pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine, Sargramostim
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
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

18 authors.

Sasha E StantonUW Medicine Cancer Vaccine Institute, University of Washington, Seattle, Washington, USA.ORCID http://orcid.org/0000-0002-4300-551X
Denise L CecilUW Medicine Cancer Vaccine Institute, University of Washington, Seattle, Washington, USA.ORCID http://orcid.org/0000-0002-9923-3618
Howard H BaileyUniversity of Wisconsin Carbone Cancer Center, Madison, Wisconsin, USA.
Ying LiuUW Medicine Cancer Vaccine Institute, University of Washington, Seattle, Washington, USA.
William R GwinUW Medicine Cancer Vaccine Institute, University of Washington, Seattle, Washington, USA.
Andrew L ColvelerUW Medicine Cancer Vaccine Institute, University of Washington, Seattle, Washington, USA.ORCID http://orcid.org/0000-0003-1710-5637
John B LiaoUW Medicine Cancer Vaccine Institute, University of Washington, Seattle, Washington, USA.ORCID http://orcid.org/0000-0002-3018-7879
Kari B WisinskiUniversity of Wisconsin Carbone Cancer Center, Madison, Wisconsin, USA.ORCID http://orcid.org/0000-0003-3535-0652
Lisa BarroilhetUniversity of Wisconsin Carbone Cancer Center, Madison, Wisconsin, USA.
KyungMann KimUniversity of Wisconsin Carbone Cancer Center, Madison, Wisconsin, USA.
Thomas C HavighurstUniversity of Wisconsin Carbone Cancer Center, Madison, Wisconsin, USA.
Katina DeShongUniversity of Wisconsin Carbone Cancer Center, Madison, Wisconsin, USA.
Kyleigh TwaroskiUniversity of Wisconsin Carbone Cancer Center, Madison, Wisconsin, USA.
Jennifer S ChildsUW Medicine Cancer Vaccine Institute, University of Washington, Seattle, Washington, USA.
Eileen DimondDivision of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA.
Margaret WojtowiczDivision of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA.
Brandy M Heckman-StoddardDivision of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA.
Mary L DisisUW Medicine Cancer Vaccine Institute, University of Washington, Seattle, Washington, USA ndisis@uw.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDuctal carcinoma in situ (DCIS) is a preinvasive form of breast cancer. Current treatment consists of surgery, radiation, and often systemic therapy exposing patients to unnecessary health risks. Vaccines targeting DCIS may be a way to intercept preinvasive lesions and prevent the development of invasive breast cancer.

methodsWe developed a Th1 selective multiantigen, polyepitope plasmid-DNA vaccine encoding segments of IGFBP-2, HER2, and IGF-IR, all antigens expressed in hormone receptor positive and negative DCIS. We then performed a Phase I study in participants with non-metastatic breast cancer with no evidence of disease. The primary objective was to assess the safety of 3 monthly intradermal doses (150, 300, or 600 µg) of the tri-antigen vaccine with granulocyte macrophage colony-stimulating factor as an adjuvant. 32 participants were enrolled, 10 per dose level. Toxicity evaluations occurred monthly with vaccination and at 1 and 6 months after the last vaccine. Blood was collected at baseline and at 1 and 6 months after the last immunization to assess cellular immune responses. Participants were followed annually for 5 years for long-term toxicity.

resultsThere was no significant difference in adverse events (AEs) across dose levels and all related AEs were grades 1 or 2. All doses were immunogenic; responders included 70% of participants at the 150 µg dose level, 67% at the 300 µg dose, and 40% at the 600 µg dose level. All participants at the 300 µg dose retained significant Th1-antigen-specific immune response at 6 months after end of immunizations. T-cells derived from vaccine immunologic responders exhibited gene expression profiles that indicated an increased metabolic fitness as compared with immunologic non-responders.

conclusionsThe tri-antigen vaccine appears safe and immunogenic. The intermediate dose (300 µg) was chosen as the Phase II dose due to the long-term persistence of immunity after vaccination. The vaccine will be studied in Phase II trials for the treatment of DCIS. TRIAL REGISTRATION NUMBER: NCT02780401.

Indexed as

Breast NeoplasmsCancer VaccinesErb-b2 Receptor Tyrosine KinasesVaccines, DNAAdultAgedAntigens, NeoplasmFemaleHumansImmunogenicity, VaccineMiddle AgedAntigens, NeoplasmCancer VaccinesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesVaccines, DNABreast CancerT cellVaccine

Identifiers

PMID42082270
PMCPMC13141069

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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.