Evidence map›Paper›PMID 23497415›Full record

ArticleJournal of translational medicine2013

Phase 1 studies of the safety and immunogenicity of electroporated HER2/CEA DNA vaccine followed by adenoviral boost immunization in patients with solid tumors.

Claudia Marcela Diaz, Alberto Chiappori, Luigi Aurisicchio, Ansuman Bagchi, Jason Clark, Sheri Dubey, Arthur Fridman, Jesus C Fabregas, John Marshall, Elisa Scarselli and 3 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Journal of translational medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 50 papers.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed
4.3field-weighted citation impact, top 5% 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.

NCT00250419 phase1completednot on this map

A Phase I Study to Evaluate the Safety/Tolerability and Immunogenicity of V-930 in Patients With Cancers Expressing HER-2 and/or CEA

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2005 to 2008Enrolled26ConditionsCancers Expressing HER-2 and/or CEAArmsV930
NCT00647114 phase1completednot on this map

A Phase I Study to Evaluate the Safety/Tolerability and Immunogenicity of V930/V932 in Patients With Cancer Expressing HER-2 and/or CEA

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2007 to 2009Enrolled41ConditionsCancerArmsV930, V932
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 77 citations in OpenAlex.

  1. Targeting Carcinoembryonic Antigen with DNA Vaccination: On-Target Adverse Events Link with Immunologic and Clinical Outcomes.Clinical cancer research : an official journal of the American Association for Cancer Research · 2016
    Trial
  2. Trial
  3. Immunotherapy in Breast Cancer: Beyond Immune Checkpoint Inhibitors.International journal of molecular sciences · 2025
    Review
  4. Article
  5. Review
  6. Review
  7. Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. Article
  13. Review
  14. Engineering neoantigen vaccines to improve cancer personalized immunotherapy.International journal of biological sciences · 2022
    Review
  15. Therapeutic vaccines for breast cancer: Has the time finally come?European journal of cancer (Oxford, England : 1990) · 2022
    Review
  16. Review
  17. Review
  18. Article
  19. Article
  20. HER2-Positive Breast Cancer Immunotherapy: A Focus on Vaccine Development.Archivum immunologiae et therapiae experimentalis · 2020
    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

13 authors at 9 institutions in 2 countries.

Claudia Marcela DiazMedical University of South Carolina, Hollings Cancer Center, Charleston, USA.
Alberto Chiappori
Luigi Aurisicchio
Ansuman Bagchi
Jason Clark
Sheri Dubey
Arthur Fridman
Jesus C Fabregas
John Marshall
Elisa Scarselli
Nicola La Monica
Gennaro Ciliberto
Alberto J Montero
IRBM Science Park · ITMerck & Co., Inc., Rahway, NJ, USA (United States) · USGeorgetown University Medical Center · USIdera Pharmaceuticals (United States) · USIncyte (United States) · USMedical University of South Carolina · USMoffitt Cancer Center · USSylvester Comprehensive Cancer Center · USUniversity of Miami · US

Funding

Enhancing T-Cell Responses with the Glutathione Mimetic NOV-002 in Breast CancerK23CA148893 · NCI · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI MONTERO, ALBERTO JOSE · 2010 to 2014
$798k
Programming T Cells for Successful Adoptive Cell TherapyK01CA134927 · NCI · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI DIAZ-MONTERO, CLAUDIA MARCELA · 2009 to 2013
$645k
NCI NIH HHS K01 CA134927NCI NIH HHS K23 CA148893
6 · The paper itself

Abstract

backgroundDNA electroporation has been demonstrated in preclinical models to be a promising strategy to improve cancer immunity, especially when combined with other genetic vaccines in heterologous prime-boost protocols. We report the results of 2 multicenter phase 1 trials involving adult cancer patients (n=33) with stage II-IV disease.

methodsPatients were vaccinated with V930 alone, a DNA vaccine containing equal amounts of plasmids expressing the extracellular and trans-membrane domains of human HER2, and a plasmid expressing CEA fused to the B subunit of Escherichia coli heat labile toxin (Study 1), or a heterologous prime-boost vaccination approach with V930 followed by V932, a dicistronic adenovirus subtype-6 viral vector vaccine coding for the same antigens (Study 2).

resultsThe use of the V930 vaccination with electroporation alone or in combination with V932 was well-tolerated without any serious adverse events. In both studies, the most common vaccine-related side effects were injection site reactions and arthralgias. No measurable cell-mediated immune response (CMI) to CEA or HER2 was detected in patients by ELISPOT; however, a significant increase of both cell-mediated immunity and antibody titer against the bacterial heat labile toxin were observed upon vaccination.

conclusionV930 vaccination alone or in combination with V932 was well tolerated without any vaccine-related serious adverse effects, and was able to induce measurable immune responses against bacterial antigen. However, the prime-boost strategy did not appear to augment any detectable CMI responses against either CEA or HER2.

trial registrationStudy 1 - ClinicalTrials.gov, NCT00250419; Study 2 - ClinicalTrials.gov, NCT00647114.

Indexed as

Genes, erbB-2AdenoviridaeAgedCancer VaccinesCarcinoembryonic AntigenEnzyme-Linked Immunosorbent AssayFemaleGenetic VectorsHumansMaleMiddle AgedNeoplasmsPlasmidsVaccines, DNACancer VaccinesCarcinoembryonic AntigenVaccines, DNA

Identifiers

PMID23497415
PMCPMC3599587
OpenAlexW2132802699

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.